An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)]
研究概览
简要总结
The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe). The study doctors will test insulin 287 to see how well it works compared to insulin glargine. The study will also test if insulin 287 is safe. The study participants will either get insulin 287 or insulin glargine (100 units/mL) - which treatment the participants get is decided by chance. The participants will need to inject their selves every day about the same time. Once a week the participant will need to take 1 extra injection on the same day of the week. The participants will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter using a finger prick, 2) write down different information in a paper diary daily and return this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2 weeks 5 times during the study.
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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
- •HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
- •Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s): Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical record) OR Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject medical record) with Dipeptidyl peptidase-4 inhibitor (DPP4i) (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subject's medical records)
- •Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
- •Body mass index (BMI) less than or equal to 40.0 kg/m^2
排除标准
- •Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation
- •Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation
- •Presently classified as being in New York Heart Association (NYHA) Class IV
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
- •Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
研究组 & 干预措施
Insulin 287
Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period.
干预措施: Insulin icodec (Drug)
Insulin 287
Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period.
干预措施: Metformin (Drug)
Insulin 287
Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period.
干预措施: Dipeptidyl peptidase-4 inhibitors (Drug)
Insulin 287
Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period.
干预措施: Placebo (insulin glargine) (Drug)
Insulin glargine
Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period.
干预措施: Placebo (insulin 287) (Drug)
Insulin glargine
Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period.
干预措施: Metformin (Drug)
Insulin glargine
Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period.
干预措施: Dipeptidyl peptidase-4 inhibitors (Drug)
Insulin glargine
Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period.
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)]
时间窗: From baseline (Visit 2) to week 26 (Visit 28)
Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i.
Change in HbA1c [Millimoles/Mole (mmol/Mol)]
时间窗: From baseline (Visit 2) to week 26 (Visit 28)
Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i.
次要结局
- Change in Fasting Plasma Glucose(From baseline (Visit 2) to week 26 (Visit 28))
- 9-point Profile (Individual SMPG Values)(Week 26 (Visit 28))
- Change in Body Weight(From baseline (Visit 2) to week 26 (Visit 28))
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (Visit 2) to week 31 (Visit 30))
- Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time(From baseline (Visit 2) to week 26 (Visit 28))
- Fasting C-peptide(At week 26 (Visit 28))
- Weekly Dose of Insulin 287 and Weekly Dose of Insulin Glargine(week 25 (Visit 27) and 26 (Visit 28))
- Number of Hypoglycaemic Alert Episodes (Level 1) (≥3.0 and <3.9 mmol/L (≥54 and <70 mg/dL), Confirmed by BG Meter)(From baseline (Visit 2) to week 26 (Visit 28))
- Change in Anti-insulin 287 Antibody Level(From baseline (Visit 2) to week 31 (Visit 30))
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)(From baseline (Visit 2) to week 26 (Visit 28))
- Number of Severe Hypoglycaemic Episodes (Level 3)(From baseline (Visit 2) to week 26 (Visit 28))
- Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time).(Week 26 (Visit 28))
- Change in Anti-insulin 287 Antibody Titres(From baseline (Visit 2) to week 31 (Visit 30))
- Change in Cross-reactive Anti-human Insulin Antibody Status (Positive/Negative)(From baseline (Visit 2) to week 31 (Visit 30))