Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00604253
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 362
Inclusion Criteria
- Duration of type 2 diabetes mellitus for at least one year
- Insulin naive patients
- OHA treatment for at least 12 weeks
- HbA1C between 7.5-10.0%
- Body Mass Index (BMI) below 30.0 kg/m2
Exclusion Criteria
- Impaired renal function
- Impaired hepatic function
- Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 36 weeks of treatment
- Secondary Outcome Measures
Name Time Method Insulin antibodies Incidence of hypoglycaemic episodes Adverse events Plasma glucose profiles
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan