protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04126031 | 12.4 | Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP | 12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable regulatory authority in any area of the world, or if the Investigator is aware of any new information that might influence the evaluation of the be... | [] |
NCT04126031 | 13 | DEFINITION OF END OF TRIAL | 13. DEFINITION OF END OF TRIAL | [] |
NCT04126031 | 13.1 | End of Trial in a Member State | 13.1. End of Trial in a Member State End of trial in a Member State of the European Union is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application (ie, clinical trial application [CTA]) and ethics application in... | [] |
NCT04126031 | 13.2 | End of Trial in All Other Participating Countries | 13.2. End of Trial in All Other Participating Countries The end of the trial in all other participating countries is defined as 'the last visit of the last subject undergoing the study' or the date of study closure in the case of early study termination, whichever date is later. The study may be terminated at individua... | [] |
NCT04126031 | 14 | SPONSOR DISCONTINUATION CRITERIA | 14. SPONSOR DISCONTINUATION CRITERIA Premature termination of this study may occur because of a regulatory authority decision, change in opinion of the IRB/EC, or investigational product safety problems, or at the discretion of Pfizer. In addition, Pfizer retains the right to discontinue development of CAZ-AVI at any t... | [] |
NCT04126031 | 15 | PUBLICATION OF STUDY RESULTS | 15. PUBLICATION OF STUDY RESULTS | [] |
NCT04126031 | 15.1 | Communication of Results by Pfizer | 15.1. Communication of Results by Pfizer Pfizer fulfills its commitment to publicly disclose clinical trial results through posting the results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance wit... | [
"www.clinicaltrials.gov",
"EudraCT",
"www.pfizer.com"
] |
NCT04126031 | 15.2 | Publications by Investigators | 15.2. Publications by Investigators Pfizer supports the exercise of academic freedom and has no objection to publication by the Principal Investigator (PI) of the results of the study based on information collected or generated by the PI, whether or not the results are favorable to the Pfizer product. However, to ensur... | [] |
NCT04126031 | 16 | REFERENCES | 16. REFERENCES - 1. AVYCAZ. (ceftazidime-avibactam) [United States Package Insert]. Allergan USA, Inc., Irvine, CA 92612. 2019. - 2. Zavicefta. (ceftazidime-avibactam) [European Summary of Product Characteristics]. Pfizer Ireland Pharmaceuticals, Ringaskiddy, County Cork, Ireland. 2018. - 3. Engle WA. Age terminology d... | [
"Appendix 1. Abbreviations",
"Appendix 2. Calculation of Corrected Age for Pre-Term Infant Eligibility for Cohort 1",
"Corrected Age (days) = PMA or CGA (days) – 280",
"Appendix 3. Table of Potential Alternative Doses of CAZ-AVI for Infants and Neonates",
"Starting dose regimens for this protocol are underl... |
NCT04153929 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT04153929 | 1.1 | MEDICAL BACKGROUND | 1.1 MEDICAL BACKGROUND Type 2 diabetes mellitus (T2DM) is a highly prevalent disease affecting 30.3 million Americans, or 9.4% of the US population in 2015. According to the American Diabetes Association, about 1.5 million Americans are newly diagnosed with type 2 diabetes every year. T2DM is associated with a variety ... | [] |
NCT04153929 | 1.2 | DRUG PROFILE | 1.2 DRUG PROFILE
Mode of action  Semaglutide is a GLP-1R agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Semaglutide has demonstrated improved glycemic control and body weight loss. The most common adverse reactions, reported in ≥5% of patie... | [
"Mode of action"
] |
NCT04153929 | 1.3 | RATIONALE FOR PERFORMING THE TRIAL | 1.3 RATIONALE FOR PERFORMING THE TRIAL BI 456906 is a dual GLP-1R and GCGR agonist being evaluated in the indications of glycemic control in T2DM and chronic weight management in obesity/overweight.  This study is a 16-week phase 2 study to examine up to 6 dose levels of BI 456906 administered o... | [] |
NCT04153929 | 1.4 | BENEFIT - RISK ASSESSMENT | 1.4 BENEFIT - RISK ASSESSMENT More information on the benefits, risks, and known AEs will be presented in the Investigator's Brochure. The US prescribing information for semaglutide will be provided which gives more information on the known and expected benefits and risks of semaglutide. | [] |
NCT04153929 | 1.4.1 | Benefits | 1.4.1 Benefits In the proposed patient population with T2DM, improvements in hyperglycemia and body weight are anticipated. The expected benefit for the selected patient population is improved glycemic control and body weight loss, and an improvement of the associated metabolic risk factors and patient reported outcome... | [
"c26686857-02 Clinical Trial Protocol Page 21 of 87"
] |
NCT04153929 | 1.4.2 | Risks | 1.4.2 Risks The risk for patients caused by the study procedures and the risks related to the exposure to the study drug are reasonably low and do not outweigh the potential benefits. The expected side effects are known to be dose dependent, easy to monitor and manageable in clinical trials. Among the expected and well... | [
"c26686857-02 Clinical Trial Protocol Page 22 of 87"
] |
NCT04153929 | 1.4.3 | Discussion | 1.4.3 Discussion BI 456906 was well tolerated in safety pharmacology and toxicology studies and the main effects seen reflected the intended pharmacology of the compound. In a multiple rising dose trial with weekly dose escalation up to 3.0 mg q.w., BI 456906 did not reveal relevant safety signals although drug-related... | [] |
NCT04153929 | 2 | TRIAL OBJECTIVES AND ENDPOINTS | 2. TRIAL OBJECTIVES AND ENDPOINTS | [] |
NCT04153929 | 2.1 | MAIN OBJECTIVES, PRIMARY AND SECONDARY ENDPOINTS | 2.1 MAIN OBJECTIVES, PRIMARY AND SECONDARY ENDPOINTS | [] |
NCT04153929 | 2.1.1 | Main objectives | 2.1.1 Main objectives The main objective of the trial is to demonstrate a dose-relationship of BI 456906 on HbA1c (absolute change) from baseline to 16 weeks relative to placebo in patients with T2DM. Secondary objectives are to assess the effect of BI 456906 on change in body weight. An open-label comparator (semaglut... | [] |
NCT04153929 | 2.1.2 | Primary endpoint | 2.1.2 Primary endpoint Absolute change in HbA1c from baseline to 16 weeks. | [] |
NCT04153929 | 2.1.3 | Secondary endpoints | 2.1.3 Secondary endpoints - 1. The relative body weight change from baseline to 16 weeks (key secondary endpoint). - 2. The absolute body weight change from baseline to 16 weeks. - 3. The absolute change in waist circumference from baseline to 16 weeks. - 4. The percentage of patients with 5% or greater body weight los... | [
"c26686857-02 Clinical Trial Protocol Page 24 of 87"
] |
NCT04153929 | 3 | DESCRIPTION OF DESIGN AND TRIAL POPULATION | 3. DESCRIPTION OF DESIGN AND TRIAL POPULATION | [] |
NCT04153929 | 3.1 | OVERALL TRIAL DESIGN AND PLAN | 3.1 OVERALL TRIAL DESIGN AND PLAN This trial is a multicenter, randomized, double-blinded within dose groups, parallel, placebo-controlled clinical trial with dose-escalation schemes in patients with T2DM. In addition, an open-label GLP-1R (semaglutide) group will be included as benchmark to compare response curves and... | [
"c26686857-02 Clinical Trial Protocol Page 26 of 87"
] |
NCT04153929 | 3.2 | DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF CONTROL GROUPS | 3.2 DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF CONTROL GROUPS This trial is designed to evaluate safety, tolerability, PK and PD of BI 456906 in male and female patients with T2DM using multiple escalation schemes and doses, and will support dose selection for phase 3 clinical development of BI 456906. To comp... | [] |
NCT04153929 | 3.3 | SELECTION OF TRIAL POPULATION | 3.3 SELECTION OF TRIAL POPULATION It is planned to screen 615 patients and randomize 410 patients with type 2 diabetes in this clinical trial. Enrollment will be competitive and patients will be enrolled in approximately 80 study sites in multiple countries. Additional study sites may be added for patient recruitment, ... | [] |
NCT04153929 | 3.3.1 | Main diagnosis for trial entry | 3.3.1 Main diagnosis for trial entry Patients with T2DM who have insufficient glycemic control despite diet, exercise and metformin treatment.
c26686857-02 Clinical Trial Protocol Page 27 of 87 Proprietary confidential information © 2020 Boehringer Ingelheim International GmbH or one or more of its affiliated companie... | [
"c26686857-02 Clinical Trial Protocol Page 27 of 87"
] |
NCT04153929 | 3.3.2 | Inclusion criteria | 3.3.2 Inclusion criteria - 1. Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial. - 2. Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent. - 3. Diagnosis of T2DM at least 6 months prior to i... | [] |
NCT04153929 | 3.3.3 | Exclusion criteria | 3.3.3 Exclusion criteria - 1. Patients with type 1 diabetes. - 2. Exposure to semaglutide, or other GLP-1R agonists (including combination products) within 3 months prior to screening, or any previous exposure to BI 456906, or history of relevant allergy or hypersensitivity (including allergy, intolerability or lack of... | [
"Examples of excluded medications:",
"c26686857-02 Clinical Trial Protocol Page 30 of 87"
] |
NCT04153929 | 3.3.4 | Withdrawal of patients from treatment or assessments | 3.3.4 Withdrawal of patients from treatment or assessments Patients may discontinue trial treatment or withdraw consent to trial participation as a whole ("withdrawal of consent") with very different implications; please see [section 3.3.4.1](#page-30-0) and [3.3.4.2](#page-31-0) below. Every effort should be made to k... | [
"c26686857-02 Clinical Trial Protocol Page 31 of 87"
] |
NCT04153929 | 3.3.4.1 | Discontinuation of trial treatment | 3.3.4.1 Discontinuation of trial treatment An individual patient will discontinue trial treatment if: - The patient wants to discontinue trial treatment, without the need to justify the decision. - An AE or clinically significant laboratory change or abnormality occurred that the investigator judges to warrant disconti... | [
"c26686857-02 Clinical Trial Protocol Page 32 of 87"
] |
NCT04153929 | 3.3.4.2 | Withdrawal of consent to trial participation | 3.3.4.2 Withdrawal of consent to trial participation Patients may withdraw their consent to trial participation at any time without the need to justify the decision. If a patient wants to withdraw consent, the investigator should be involved in the discussion with the patient and explain the difference between trial tr... | [] |
NCT04153929 | 3.3.4.3 | Discontinuation of the trial by the sponsor | 3.3.4.3 Discontinuation of the trial by the sponsor Boehringer Ingelheim reserves the right to discontinue the trial overall or at a particular trial site at any time for the following reasons: - 1. Failure to meet expected enrollment goals overall or at a particular trial site. - 2. Emergence of any efficacy/safety in... | [] |
NCT04153929 | 4 | TREATMENTS | 4. TREATMENTS  c26686857-02 Clinical Trial Protocol Page 34 of 87 c26686857-02 Clinical Trial Protocol Page 35 of 87 Proprietary confidential information © 2020 Boehringer Ingelheim International GmbH or one or more of its affiliated companies  | [] |
NCT04153929 | 4.1.2 | Selection of doses in the trial and dose modifications | 4.1.2 Selection of doses in the trial and dose modifications Doses from 0.3 mg to 3.6 mg were selected for weekly or twice-weekly dosing based on the following considerations: Safety and tolerability of BI 456906 was evaluated in healthy subjects and patients with obesity/overweight up to 16 weeks for doses up to 3.15 ... | [
"c26686857-02 Clinical Trial Protocol Page 36 of 87"
] |
NCT04153929 | 4.1.3 | Method of assigning patients to treatment groups | 4.1.3 Method of assigning patients to treatment groups After the assessment of all inclusion and exclusion criteria, each eligible patient will be randomized to one of the dose groups (dose groups 1 to 6 or semaglutide). Within dose groups 1 to 6, patients will be randomized to active or placebo in a 5:1 ratio. Semaglu... | [] |
NCT04153929 | 4.1.4 | Drug assignment and administration of doses for each patient | 4.1.4 Drug assignment and administration of doses for each patient Table 4.1.4: 1 shows the dose groups and the dose escalation scheme within each dose group. Table 4.1.4: 1 Dose escalation scheme\ | Treatment | | Weekly/twice weekly dosing | | in (mg) | | | | |-----------------------------------|--------------|-------... | [
"COVID-19 pandemic: contingency plan:"
] |
NCT04153929 | 4.1.5 | Blinding and procedures for unblinding | 4.1.5 Blinding and procedures for unblinding | [] |
NCT04153929 | 4.1.5.1 | Blinding | 4.1.5.1 Blinding The trial has a double blind design within each dose group (dose groups 1 to 6). Patients, investigators and everyone involved in trial conduct or analysis or with any other interest in this trial will remain blinded with regard to the randomized treatment assignments until after database lock. The sem... | [] |
NCT04153929 | 4.1.5.2 | Unblinding and breaking the code | 4.1.5.2 Unblinding and breaking the code Emergency unblinding will be available to the investigator via IRT. It must be used only in an emergency situation when the identity of the study drug must be known to the investigator in order to provide appropriate medical treatment or otherwise assure safety of trial particip... | [] |
NCT04153929 | 4.1.6 | Packaging, labelling, and re-supply | 4.1.6 Packaging, labelling, and re-supply The investigational medicinal products will be provided by BI or a designated contract research organization (CRO). They will be packaged and labelled in accordance with the principles of Good Manufacturing Practice. Re-supply to the sites will be managed via the IRT system, wh... | [] |
NCT04153929 | 4.1.7 | Storage conditions | 4.1.7 Storage conditions Drug supplies will be kept at the site in their original packaging and in a secure limited access storage area according to the recommended storage conditions on the medication label. A temperature log must be maintained at the study site for documentation. If the storage conditions are found t... | [] |
NCT04153929 | 4.1.8 | Drug accountability | 4.1.8 Drug accountability The investigator or designee will receive the investigational drugs delivered by the sponsor when the following requirements are fulfilled: - Approval of the clinical trial protocol by the Institutional Review Board (IRB) / ethics committee, - Availability of a signed and dated clinical trial ... | [
"c26686857-02 Clinical Trial Protocol Page 41 of 87"
] |
NCT04153929 | 4.2 | OTHER TREATMENTS, EMERGENCY PROCEDURES, RESTRICTIONS | 4.2 OTHER TREATMENTS, EMERGENCY PROCEDURES, RESTRICTIONS | [] |
NCT04153929 | 4.2.1 | Other treatments and emergency procedures | 4.2.1 Other treatments and emergency procedures Rescue medication, for the treatment of hyperglycemia, can be initiated in patients that meet the following criteria: - The patient is fully compliant with assigned therapeutic regimen, and - Either of the following measurements for fasting blood glucose (FBG) occurs in t... | [
"Hypoglycemic Events:",
"c26686857-02 Clinical Trial Protocol Page 42 of 87"
] |
NCT04153929 | 4.2.2 | Restrictions | 4.2.2 Restrictions | [] |
NCT04153929 | 4.2.2.1 | Restrictions regarding concomitant treatment | 4.2.2.1 Restrictions regarding concomitant treatment Patients should continue to take the same dose of metformin that they were on at the time of randomization in the trial. Investigator may reduce the dose if hypoglycemic episodes are observed. However, the metformin dose should be at least 1000 mg/day. If there is ch... | [] |
NCT04153929 | 4.2.2.2 | Restrictions on diet and life style | 4.2.2.2 Restrictions on diet and life style Patients participating in the trial should refrain from donating blood during the entire duration of the trial which includes the follow-up period. Patients will receive dietary and exercise counseling for management of T2DM, at clinic visits specified in the [Flow Chart](#pa... | [] |
NCT04153929 | 4.2.2.3 | Contraception requirements | 4.2.2.3 Contraception requirements WOCBP (for the definition please refer to [section 3.3.2](#page-26-0)) and their male sexual partner able to father a child must use two medically approved methods of birth control throughout the trial, and for a period of at least 5 weeks after last study drug intake, one male barrie... | [] |
NCT04153929 | 4.3 | TREATMENT COMPLIANCE | 4.3 TREATMENT COMPLIANCE Patients should be encouraged to be fully compliant with the medication dosing schedule. Patients should be compliant on clinic visits within the protocol allowed time window. at home with pre-filled syringes or single-patient-use-pen. c26686857-02 Clinical Trial Protocol Page 44 of 87 Propriet... | [] |
NCT04153929 | 5 | ASSESSMENTS | 5. ASSESSMENTS | [] |
NCT04153929 | 5.1 | ASSESSMENT OF EFFICACY | 5.1 ASSESSMENT OF EFFICACY The primary endpoint is the absolute change in HbA1c from baseline to 16 weeks. Throughout the protocol, the term "baseline" refers to the last observation prior to administration of the first dose of the study drug. Secondary endpoints are directed towards assessment of body weight changes, ... | [] |
NCT04153929 | 5.1.1 | HbA1c | 5.1.1 HbA1c Blood samples will be taken from patients for the determination of HbA1c at the central laboratory. Further details about sample collection, handling, shipment, and assay procedures can be found in the central laboratory manual. | [] |
NCT04153929 | 5.1.2 | Weight and waist circumference | 5.1.2 Weight and waist circumference Weight measurements should always be done on the same scales for one patient whenever possible. Mechanical and digital scales are acceptable. In order to get comparable body weight values, shoes, coats/jackets, and any headgear should be taken off, and pockets should be emptied of h... | [] |
NCT04153929 | 5.2 | ASSESSMENT OF SAFETY | 5.2 ASSESSMENT OF SAFETY | [] |
NCT04153929 | 5.2.1 | Vital signs | 5.2.1 Vital signs Vital signs will be evaluated at the time points specified in the [Flow Chart](#page-4-1), prior to blood sampling. This includes systolic and diastolic blood pressure, pulse rate (electronically or by palpation count for 1 minute) in a seated position without crossed legs after 5 minutes of rest, res... | [] |
NCT04153929 | 5.2.2 | Physical examination | 5.2.2 Physical examination A complete physical examination will be performed at the time points specified in the Flow Chart. The physical examination should be conducted according to the local medical practice. It should include at a minimum general appearance, neck, lungs, cardiovascular system, abdomen, extremities, ... | [] |
NCT04153929 | 5.2.3 | Safety laboratory parameters | 5.2.3 Safety laboratory parameters Safety laboratory parameters to be assessed are listed in [Table 5.2.3: 1.](#page-46-0) For the sampling time points please see the Flow Chart. All analyses will be performed by a central laboratory, and the respective reference ranges will be provided in the ISF. Instructions regardi... | [] |
NCT04153929 | 5.2.4 | Electrocardiogram | 5.2.4 Electrocardiogram A 12-lead ECG should be collected at the time points specified in the Flow [Chart.](#page-4-1) ECG will be recorded in triplicate at the screening visit (i.e. three single ECGs recorded within 180 seconds). Centralized ECG services will be provided by an external vendor for all clinic visits (in... | [
"c26686857-02 Clinical Trial Protocol Page 49 of 87"
] |
NCT04153929 | 5.2.5 | Other safety parameters | 5.2.5 Other safety parameters | [] |
NCT04153929 | 5.2.5.1 | Suicidal risk assessment and reporting | 5.2.5.1 Suicidal risk assessment and reporting There has been no suicidal risk identified for BI 456906 in clinical data obtained to date. However, evaluation of suicidal behavior and ideation is important in clinical development and the Columbia-Suicide Severity Rating Scale, C-SSRS, will be used to prospectively asse... | [
"c26686857-02 Clinical Trial Protocol Page 50 of 87"
] |
NCT04153929 | 5.2.5.2 | Self monitoring of blood glucose | 5.2.5.2 Self monitoring of blood glucose All patients will be provided an electronic blood glucose monitoring device and supplies for use at home during the trial for self-measurement of blood glucose. Patients may also use their own device for SMBG monitoring. The SMBG device is dispensed to the patient at the screeni... | [
"c26686857-02 Clinical Trial Protocol Page 51 of 87"
] |
NCT04153929 | 5.2.6 | Assessment of adverse events | 5.2.6 Assessment of adverse events | [] |
NCT04153929 | 5.2.6.1 | Definitions of adverse events | 5.2.6.1 Definitions of adverse events | [] |
NCT04153929 | 5.2.6.1.1 | Adverse event | 5.2.6.1.1 Adverse event An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abno... | [] |
NCT04153929 | 5.2.6.1.2 | Serious adverse event | 5.2.6.1.2 Serious adverse event A serious adverse event (SAE) is defined as any AE, which fulfils at least one of the following criteria: - results in death, - is life-threatening, which refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event that hypothetica... | [
"c26686857-02 Clinical Trial Protocol Page 52 of 87"
] |
NCT04153929 | 5.2.6.1.3 | AEs considered "Always Serious" | 5.2.6.1.3 AEs considered "Always Serious" In accordance with the European Medicines Agency initiative on Important Medical Events, Boehringer Ingelheim has set up a list of further AEs, which by their nature, can always be considered to be "serious" even though they may not have met the criteria of an SAE as defined ab... | [] |
NCT04153929 | 5.2.6.1.4 | Adverse events of special interest | 5.2.6.1.4 Adverse events of special interest AESIs relates to any specific AE that has been identified at the project level as being of particular concern for prospective safety monitoring and safety assessment within this trial, e.g. the potential for AEs based on knowledge from other compounds in the same class. AESI... | [] |
NCT04153929 | 5.2.6.1.5 | Intensity (severity) of AEs | 5.2.6.1.5 Intensity (severity) of AEs The intensity (severity) of the AE should be judged based on the following: Mild: Awareness of sign(s) or symptom(s) that is/are generally tolerated. Moderate: Sufficient discomfort to cause interference with usual activity. Severe: Incapacitating or causing inability to work or to... | [
"Mobitz (type) I atrioventricular block",
"Mobitz (type) II atrioventricular block",
"Sinus tachycardia",
"Electrocardiogram QT corrected interval prolonged"
] |
NCT04153929 | 5.2.6.1.6 | Causal relationship of AEs | 5.2.6.1.6 Causal relationship of AEs Medical judgement should be used to determine whether there is a reasonable possibility of a causal relationship between the AE and the given study treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confou... | [
"c26686857-02 Clinical Trial Protocol Page 55 of 87"
] |
NCT04153929 | 5.2.6.2 | Adverse event collection and reporting | 5.2.6.2 Adverse event collection and reporting | [] |
NCT04153929 | 5.2.6.2.1 | AE Collection | 5.2.6.2.1 AE Collection The investigator shall maintain and keep detailed records of all AEs in the patient files. The following must be collected and documented on the appropriate eCRF(s) by the investigator: - From signing the informed consent onwards until the individual patient's end of trial: all AEs (serious and ... | [] |
NCT04153929 | 5.2.6.2.2 | AE reporting to the sponsor and timelines | 5.2.6.2.2 AE reporting to the sponsor and timelines The investigator must report SAEs, AESIs, and non-serious AEs which are relevant for the reported SAE or AESI, on the BI SAE form immediately (within 24 hours ) to the sponsor's unique entry point (country specific reporting process will be provided in the ISF). The s... | [] |
NCT04153929 | 5.2.6.2.3 | Pregnancy | 5.2.6.2.3 Pregnancy In rare cases, pregnancy might occur in a clinical trial. Once a patient has been enrolled in the clinical trial and has taken study drug, the investigator must report any drug exposure during pregnancy in a trial participant immediately (within 24 hours) by means of Part A of the Pregnancy Monitori... | [] |
NCT04153929 | 5.4 | IMMUNOGENICITY | 5.4 IMMUNOGENICITY | [] |
NCT04153929 | 5.4.1 | Timing of immunogenicity measures | 5.4.1 Timing of immunogenicity measures Blood samples from patients will be obtained from patients receiving BI 456906 or placebo for the determination of ADA and neutralizing antibody (NAb) at the time points detailed in [Flow Chart](#page-4-1). Blood samples will not be taken from patients in the semaglutide group (d... | [] |
NCT04153929 | 5.5 | ASSESSMENT OF BIOMARKERS | 5.5 ASSESSMENT OF BIOMARKERS Several exploratory biomarkers will be determined as indirect response to study drug administration. Samples will be collected for biomarker analysis as shown in the Flow Chart.  BI Trial No.: 1404-0002 c26686857-02 Clinical Trial Protocol Page 59 of 87  to one of the dose groups (dose groups 1 to 6 or semaglutide). During the treatment period, there will be a dose escalation period (for dose... | [
"Pregnancy tests",
"c26686857-02 Clinical Trial Protocol Page 63 of 87"
] |
NCT04153929 | 6.2 | DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS | 6.2 DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS | [] |
NCT04153929 | 6.2.1 | Screening and run-in period | 6.2.1 Screening and run-in period
Screening (visit 1) No trial procedures should be performed until the patient has consented to take part in the trial. If the patient is willing to provide a blood sample for unspecified pharmacogenomics and biomarker testing (biobanking), a separate consent must be obtained. Each pat... | [
"Screening (visit 1)",
"Discontinuation during the screening period",
"Rescreening and retesting",
"c26686857-02 Clinical Trial Protocol Page 64 of 87"
] |
NCT04153929 | 6.2.2 | Treatment period | 6.2.2 Treatment period Patients who meet all the protocol criteria will be randomized at visit 2. After randomization, patients will start the treatment period which includes a dose escalation phase, followed by the dose maintenance phase as shown in [Figure 3.1:](#page-24-0) 1. Procedures to be completed at each clini... | [
"Discontinuation during the treatment period"
] |
NCT04153929 | 6.2.3 | Follow-up period and trial completion | 6.2.3 Follow-up period and trial completion The four-week follow-up period extends from visit 12 until visit 13. Visit 13 will be 5 weeks after the last dose (visit 11) which is the residual effect period in this trial. Procedures to be completed at the follow-up visit can be found in the [Flow Chart](#page-4-1). The s... | [] |
NCT04153929 | 7 | STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE | 7. STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE The primary trial objective includes demonstration of PoCC with respect to a non-flat dose response curve, characterization of the dose-response relationship within the therapeutic range, and selection of the dose range for phase III development. For this purpose,... | [] |
NCT04153929 | 7.1 | NULL AND ALTERNATIVE HYPOTHESES | 7.1 NULL AND ALTERNATIVE HYPOTHESES The null hypothesis is that there is a flat dose response curve comparing the placebo and the BI 456906 dose groups. The alternative hypothesis is that there is a non-flat dose response curve indicating a benefit of BI 456906 over Placebo. The MCPMod procedure allows for simultaneous... | [] |
NCT04153929 | 7.2 | PLANNED ANALYSES | 7.2 PLANNED ANALYSES | [] |
NCT04153929 | 7.2.1 | General considerations | 7.2.1 General considerations For the dose-finding all randomized patients with at least 1 post-baseline measurement according to the treatment the patients were assigned will be included in the primary analysis. More details and all other analysis sets will be specified in the TSAP. | [] |
NCT04153929 | 7.2.2 | Primary endpoint analyses | 7.2.2 Primary endpoint analyses The analyses for PoCC and dose-finding will be performed using MCPMod [[R10-1424\]](#page-78-0) whereby several possible dose response models (patterns) will be evaluated, while keeping full control of the type I error at 2.5%, one-sided) to identify the best-fitting model or subset of m... | [] |
NCT04153929 | 7.2.3 | Secondary endpoint analyses | 7.2.3 Secondary endpoint analyses For the key secondary endpoint body weight, analyses similar to the primary analysis of HbA1c will be performed. The absolute and relative body weight change as well as change in waist circumference will be assessed using an MMRM analysis as for the primary endpoint analysis. The estim... | [] |
NCT04153929 | 7.2.5 | Safety analyses | 7.2.5 Safety analyses Adverse events will be coded using the Medical Dictionary for Drug Regulatory Activities (MedDRA). Standard BI summary tables and listings will be produced. All adverse events with an onset between start of treatment and end of the REP, a period of 5 weeks after the last dose of study drug, will b... | [] |
NCT04153929 | 7.2.7 | Interim Analyses | 7.2.7 Interim Analyses Interim analyses may be performed during the conduct of this trial. A limited number of the sponsor staff will be unblinded for the conduct of the interim analysis. Investigators, study site staff, trial team, and patients will remain blinded. If a decision is made to perform an interim analysis,... | [] |
NCT04153929 | 7.3 | HANDLING OF MISSING DATA | 7.3 HANDLING OF MISSING DATA For the primary endpoint the MMRM will be used to handle missing values. The imputation rules for secondary and further endpoints will be specified in the TSAP. | [] |
NCT04153929 | 7.4 | RANDOMIZATION | 7.4 RANDOMIZATION BI will arrange for the randomization and the packaging and labelling of study drug. The randomization list(s) will be generated using a validated system, which involves a pseudorandom number generator so that the resulting treatment will be both reproducible and nonpredictable. The block size will be... | [] |
NCT04153929 | 7.5 | PATIENTS DETERMINATION OF SAMPLE SIZE | 7.5 PATIENTS DETERMINATION OF SAMPLE SIZE The sample size calculation is based on an assumed maximum effect size of BI 456906 vs. placebo of 0.5% change in HbA1c for the primary endpoint, as well as on the pre-specified models listed in [section 5.1.2](#page-44-1). The maximum effect size is assumed to be 0.5% with the... | [] |
NCT04153929 | 8 | INFORMED CONSENT, TRIAL RECORDS, DATA PROTECTION, PUBLICATION POLICY, AND ADMINISTRATIVE STRUCTURE | 8. INFORMED CONSENT, TRIAL RECORDS, DATA PROTECTION, PUBLICATION POLICY, AND ADMINISTRATIVE STRUCTURE The trial will be carried out in compliance with the protocol, the ethical principles laid down in the Declaration of Helsinki, in accordance with the ICH Harmonized Guideline for Good Clinical Practice, relevant BI SO... | [] |
NCT04153929 | 8.1 | TRIAL APPROVAL, PATIENT INFORMATION, INFORMED CONSENT | 8.1 TRIAL APPROVAL, PATIENT INFORMATION, INFORMED CONSENT This trial will be initiated only after all required legal documentation has been reviewed and approved by the respective IRB / Independent Ethics Committee (IEC) and competent authority, according to national and international regulations. The same applies for ... | [
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NCT04153929 | 8.2 | DATA QUALITY ASSURANCE | 8.2 DATA QUALITY ASSURANCE A risk-based approach is used for trial quality management. It is initiated by the assessment of critical data and processes for trial participant protection and reliability of the results as well as identification and assessment of associated risks. An Integrated Quality and Risk Management ... | [] |
NCT04153929 | 8.3 | RECORDS | 8.3 RECORDS Electronic CRFs for individual patients will be provided by the sponsor. See [section 4.1.5.2](#page-38-0) for rules about emergency code breaks. For drug accountability, refer to [section 4.1.8](#page-39-0). | [] |
NCT04153929 | 8.3.1 | Source documents | 8.3.1 Source documents In accordance with regulatory requirements, the investigator should prepare and maintain adequate and accurate source documents and trial records that include all observations and other data pertinent to the investigation on each trial patient. Source data as well as reported data should follow t... | [] |
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