Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: NPH insulin
- Registration Number
- NCT03220425
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
Inclusion Criteria
- Signed and dated informed consent obtained before any trial-related activities
- Type 1 diabetes diagnosed and classified according to aetiology
- Duration of type 1 diabetes equal to or more than 12 months
- Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
- Able and willing to perform self-blood glucose monitoring
Exclusion Criteria
- Proliferative retinopathy
- Total basal insulin dose of more than 100 IU per day
- Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
- Known unawareness of hypoglycaemia
- Previous treatment with insulin detemir
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NPH insulin NPH insulin - Insulin detemir Insulin detemir -
- Primary Outcome Measures
Name Time Method The change in the level of glycosylated haemoglobin(HbA1c) From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧York, United Kingdom