Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00619697
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
- Type 2 diabetes for at least 6 months
- Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
- Previous treatment with oral antidiabetic drugs for at least 4 months
- Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
- BMI below 40 kg/m2
- HbA1c between 7-12%
- Able and willing to perform self-plasma glucose monitoring
Exclusion Criteria
- The receipt of any other investigational drug within 4 weeks before screening
- A history of drug or alcohol abuse within the last 12 months
- Severe, uncontrolled hypertension
- Known or suspected allergy to trial products or related products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method HbA1c after 16 weeks of treatment Plasma glucose profiles Change in body mass index Incidence of hypoglycaemic episodes Safety profile
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇮Maribor, Slovenia