A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 708
- 试验地点
- 1
- 主要终点
- HbA1c (Glycosylated Haemoglobin) at Month 12
研究概览
简要总结
This trial is conducted in Europe.
The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
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
- None
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
- •Type 2 diabetes
- •Insulin naive
- •On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination
- •Body Mass Index (BMI) below or equal to 40.0 kg/m2
- •HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)
排除标准
- •Proliferative retinopathy
- •Recurrent major hypoglycaemia
- •Cardial problems
- •Uncontrolled hypertension
- •Impaired hepatic or renal function
研究组 & 干预措施
Insulin detemir (basal insulin)
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen.
干预措施: insulin detemir (Drug)
Insulin aspart (prandial insulin)
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen.
干预措施: biphasic insulin aspart (Drug)
Biphasic insulin aspart 30 (biphasic insulin)
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen.
干预措施: insulin aspart (Drug)
结局指标
主要结局
HbA1c (Glycosylated Haemoglobin) at Month 12
时间窗: Baseline, Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
HbA1c (Glycosylated Haemoglobin) at Month 36
时间窗: Baseline, Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
次要结局
- Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%(Month 12)
- Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%(Month 36)
- Percentage of Participants Who Required A Second Insulin Therapy by Month 12(Month 12)
- Percentage of Participants Who Required A Second Insulin Therapy by Month 36(Month 36)
- Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%(Month 36)
- Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%(Month 12)
- Change From Baseline in Body Weight at Month 12(Week 0 (baseline), month 12)
- Change From Baseline in Body Weight at Month 36(Week 0 (baseline), month 36)
- Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months(Baseline, month 12)
- Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months(Baseline, month 36)
- Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months(Month 12)
- Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months(Month 36)
- Number of Participants Having an 'Other' Adverse Event(Up to month 37 (36 months of treatment plus 1 month follow-up))