Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00604344
- 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 subjects with insulin requiring diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
Inclusion Criteria
- Duration of diabetes mellitus for at least 2 years
- Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
- HbA1C below 11.0%
Exclusion Criteria
- Impaired renal function
- Impaired hepatic function
- Serious heart diseases
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- Proliferative retinopathy or maculopathy requiring acute treatment
- Uncontrolled treated/untreated hypertension
- Current treatment with total insulin dose of more than 100 IU/day
- Current treatment or expected at the screening to start treatment with systemic corticosteroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 48 weeks of treatment
- Secondary Outcome Measures
Name Time Method Body weight Blood glucose profiles Hypoglycaemic episodes Adverse events Insulin antibodies
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan