Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
NCT00184665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501
Last updated 2017-01-27
Summary
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).
Conditions
- Diabetes
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
insulin detemir
- DRUG
-
insulin NPH
- DRUG
-
insulin aspart
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Primary Completion
- 2006-09-30
- Completion
- 2006-09-30
Countries
- Argentina
- Australia
- Bulgaria
- Croatia
- India
- Malaysia
- North Macedonia
- Romania
- South Africa
- Turkey (Türkiye)
Study Locations
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