Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Registration Number
- NCT00592969
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
Inclusion Criteria
- Type 2 diabetes
- Currently treated with insulin NPH or are insulin-naive
- Body mass index (BMI) below 35.0 kg/m2
- HbA1c between 7.5-11.0%
Exclusion Criteria
- Participation in any other clinical trial involving investigational products within the last 3 months
- History of drug or alcohol dependence
- Known impaired hepatic function
- Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Adverse events Hypoglycemia PPBG values Glucose profiles
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇧🇷Santa Efigenia, Brazil