A Randomised, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)
研究概览
简要总结
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
详细描述
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments.
During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject aged 18-70 years (both inclusive)
- •Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- •HbA1c level between 7.5% and 9.5% (both inclusive)
- •Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
- •Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening
排除标准
- •Type 1 diabetes mellitus
- •Known or suspected allergy to the IMPs or related products
- •Previous participation in this trial. Participation is defined as randomised.
- •Receipt of any medicinal product in clinical development within 60 days prior to this trial.
- •Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation screening tests, as judged by the Investigator considering the underlying disease
- •Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50-90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.
- •Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-
- •The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening.
- •Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor within 4 weeks prior to screening
- •Women of child bearing potential not willing to use contraceptive methods.
研究组 & 干预措施
BioChaperone® Combo
Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: BioChaperone® Combo (Drug)
BioChaperone® Combo
Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Placebo (Drug)
Humalog® Mix25
Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Humalog® Mix25 (Drug)
Humalog® Mix25
Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Placebo (Drug)
Humalog® and Lantus®
Individualised simultaneous subcutaneous injections
干预措施: Humalog® (Drug)
Humalog® and Lantus®
Individualised simultaneous subcutaneous injections
干预措施: Lantus® (Drug)
结局指标
主要结局
Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)
时间窗: From 0 to 2 hours
Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3
次要结局
- Cmax Insulin(From 0 to 6 hours)
- Mean and mean change from baseline of blood glucose at different time points(From 0 to 6 hours)
- AUC Insulin(From 0 to 24 hours)
- Delta BGmax and delta BGmin(From 0 to 6 hours)
- tmax Insulin(From 0 to 6 hours)
- Adverse Events(Up to 12 weeks (maximum duration of subject's participation))
- Partial delta AUCs BG and total AUCs BG(From 0 to 6 hours)
- BGmax and BGmin(From 0 to 6 hours)
- Local tolerability(Up to 12 weeks (maximum duration of subject's participation))
- Hypoglycaemic events(Up to 12 weeks (maximum duration of subject's participation))