Comparison of two NN1250 formulations versus insulin glargine, all in combination with metformin in subjects with type 2 diabetes
Phase 2
Completed
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Diabetes Mellitus, Type 2
- Registration Number
- CTRI/2007/091/000042
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
Inclusion Criteria
1. Insulin naive type 2 subjects for at least 3 months
2. Treatment with a stable dosing of maximally tolerated dose or at least half maximally allowed dose of one or two OADs for at least 2 months
3. HbA1c 7.0-11.0% (both inclusive)
4. Body mass index (BMI) 25-42 kg/m2 (both inclusive)
Exclusion Criteria
1. Metformin contraindication according to local practice
2. Treatment with thiazolidinedione (TZD) within the last 3 months prior to screening
3. Any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) 3 months prior to randomisation
4. Any disease or condition which according to the investigator would interfere with the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1cTimepoint: After 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method 1. Plasma glucose profiles For the duration of the trial<br>2. Incidence of hypoglycaemic episodes For the duration of the trial<br>3. Frequency and severity of adverse events For the duration of the trial<br>4. Laboratory safety parameters For the duration of the trial<br>5. Physical examination and vital signs For the duration of the trial<br>Timepoint: After 16 weeks of treatment