Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Registration Number
- NCT00598793
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
Inclusion Criteria
- Insulin naive Type 2 diabetes
- Currently treated with OADs alone or combined with other treatment for at least 3 months
- BMI below 40 kg/m2 and body weight below 125 kg
- HbA1c greater than or equal to 8%
Exclusion Criteria
- Inability to tolerate metformin or contradictions to its use
- Pregnant, breastfeeding or intention of becoming pregnant
- Allergy to any of the trial products
- Inability or unwillingness to perform SMBG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 28 weeks of treatment
- Secondary Outcome Measures
Name Time Method Postprandial glucose by 8-point SMBG Number of subjects achieving HbA1c below 7% Number of hypoglycemic episodes and adverse events Weight change Insulin dose
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Renton, Washington, United States