Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Drug: human soluble insulin
- Registration Number
- NCT01486966
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.
The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 58
- Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer
- Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)
- Body Mass Index (BMI) equal to 40 kg/m^2 or below
- HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis
- Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation
- Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening
- Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors
- Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description insulin NPH human soluble insulin - insulin NPH insulin NPH - Insulin detemir / IAsp insulin detemir - Insulin detemir / IAsp metformin - Insulin detemir / IAsp insulin aspart - insulin NPH metformin -
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment Week 0, week 2 Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment Week 2 FPG target was \< 6.0 mmol / L, 2hPPG target was \< 8.0 mmol / L.
Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment Week 2 FPG target was \< 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).
Change From Baseline in Fructosamine After Two Weeks of Treatment Week 0, week 2 Incidence of Hypoglycaemic Episodes Weeks 0-2 All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.
Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) \< 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value \< 3.1 mmol/l (56 mg/dl).
A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal.Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment Week 0, week 2 The FPG referred to pre-breakfast plasma glucose.
Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment Week 0, week 2 The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.
Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment Week 0, week 2 The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.
Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment Week 2 Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment Week 2
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇳Shanghai, Shanghai, China