Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00791895
- 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 investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
- Type 2 diabetes mellitus for at least 12 months
- HbA1c: 7.5-10.0%
- An antidiabetic regimen that has been stable for at least 3 months
- Able and willing to perform SMBG testing as per protocol
Exclusion Criteria
- Use of any insulin preparations other than NPH or glargine within the past 6 months
- Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
- Known or suspected allergy to trial product or agents related to trial product
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A biphasic insulin aspart 30 -
- Primary Outcome Measures
Name Time Method Percentage of subjects achieving HbA1c below 6.5% after 16, 32 and 48 weeks, respectively
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Milwaukee, Wisconsin, United States