Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.
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
- Double (Participant, Investigator)
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
- •BMI above or equal to 25 and below or equal to 40 kg/m^2
- •Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
- •HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)
排除标准
- •Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Chronic malabsorption, regardless of aetiology
- •History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- •Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
研究组 & 干预措施
1:Semaglutide tablets : 2.5 mg
2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
2:Semaglutide tablets: 2.5 mg/5 mg
2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
3:Semaglutide tablets: 5.0 mg/10 mg
5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
4:Semaglutide tablets:5.0 mg/10 mg/20 mg
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks.
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg
5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks.
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
8:Placebo tablets
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: oral placebo (Drug)
9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
干预措施: semaglutide (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, week 26
Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
次要结局
- Change in Waist Circumference(Week 0, week 26)
- Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)(After 26 weeks of treatment)
- Number of Treatment Emergent Adverse Events (TEAEs) Recorded(Weeks 0-31)
- Change in Body Weight(Week 0, Week 26)
- Change in Body Mass Index (BMI)(Week 0, week 26)
- Number of Confirmed Hypoglycaemic Episodes Recorded(Weeks 0-31)