A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 269
- 主要终点
- Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
研究概览
简要总结
This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join.
The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine.
Depending on a person's diabetes treatment, a person will be assigned either to
- Part A: healthy eating and physical activity
- Part B: diabetes tablets (no injection of insulin)
- Part C: injection of insulin (with or without diabetes tablets)
Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment.
Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- •Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)/European association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C:
- •Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol/mol) and <9.5% (<80 mmol/mol) as measured by the central laboratory at screening (Visit 1);
- •Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and/or Maximum tolerated dose of sulfonylurea and/or Maximum tolerated dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and HbA1c ≥7.0% (≥53 mmol/mol) and <10.5% (<91 mmol/mol) as measured by the central laboratory at screening (Visit 1);
- •Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)/day with or without stable dose of metformin and/or SGLT2i for 90 days prior to screening (Visit 1) and HbA1c ≥7.0% (≥53 mmol/mol) and <10.5% (<91 mmol/mol) as measured by the central laboratory at screening (Visit 1)
- •Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
- •Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
- •Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per international council for harmonisation of technical requirements for pharmaceuticals for human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- •In the investigator's opinion, participants are well-motivated, capable, and willing to: Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP); Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a diary, complete required questionnaires, and handle the IMP as described in the instructions for use (IFU)
排除标准
- •Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
- •Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R) agonists including GLP-1R agonist/glucose-dependent insulinotropic polypeptide (GIP) combinations, amylin or incretin combinations; Glucose-lowering drugs other than stated in the inclusion criteria for each part (i.e. metformin, Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i), basal insulin, depending on the background therapy part); Glucose-lowering investigational drug; Any anti-obesity medication including bupropion/naltrexone, orlistat, phentermine, and phentermine/topiramate
- •History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
- •Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)
- •Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study
- •Body weight change (self-reported) >5% within 90 days before screening (Visit 1)
- •Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, including any prior bariatric surgery. The following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening (Visit 1), (2) lap banding, if the band has been removed >1 year before screening (Visit 1), (3) intragastric balloon, if the balloon has been removed >1 year before screening (Visit 1), (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening (Visit 1).
- •Answered "yes" to any of the suicide-related behaviours (Actual attempt, Interrupted attempt, Aborted attempt, Preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the "Suicidal Behaviour" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening (Visit 1) up to and including randomisation (Visit 2)
- •Further exclusion criteria apply.
研究组 & 干预措施
Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
干预措施: Survodutide (Drug)
Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
干预措施: Survodutide (Drug)
Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
干预措施: Survodutide (Drug)
Part A: Placebo
Placebo as an add-on to diet and exercise.
干预措施: Placebo (Drug)
Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
干预措施: Placebo (Drug)
Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
干预措施: Placebo (Drug)
Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
干预措施: Survodutide (Drug)
Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
干预措施: Survodutide (Drug)
Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
干预措施: Survodutide (Drug)
结局指标
主要结局
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
时间窗: At baseline and Week 41.
次要结局
- Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53(At baseline and Week 53.)
- Relative change in triglycerides from baseline to Week 53(At baseline and Week 53.)
- Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53(At baseline and Week 53.)
- Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41(At baseline and Week 41.)
- Achievement of HbA1c <5.7% (yes/no) at Week 41(At Week 41.)
- Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53(At baseline and Week 53.)
- Percent change in body weight (kg) from baseline to Week 53(At baseline and Week 53.)
- Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53(At baseline and Week 53.)
- Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable(At baseline and Week 53.)
- Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53(At baseline and Week 53.)
- Part C: Absolute change in daily basal insulin dose from baseline to Week 53(At baseline and Week 53.)