Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00537303
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe, Africa and the United States of America (USA).
The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 296
- Type 2 diabetes mellitus for more than 6 months
- HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
- BMI (Body Mass Index) less than 40 kg/m2
- Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
- Treatment with one to 3 OADs
- Known or suspected allergy to trial products or related products
- Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
- Previous participation in any trial including this for the last 6 months
- Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Advanced insulin detemir Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively. Advanced insulin aspart Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively. Basic insulin aspart Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively. Basic insulin detemir Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
- Primary Outcome Measures
Name Time Method Glycosylated Haemoglobin A1c (HbA1c) week 36 Measured for the Per Protocol analysis set.
- Secondary Outcome Measures
Name Time Method Hypoglycaemic Episodes Weeks 0-36 Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Biochemistry: Serum Alanine Aminotransferase week 36 Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.
Haematology: Haemoglobin Measured in Blood week 36 Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.
Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide week 36 High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Rugby, United Kingdom