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TITRATE: Insulin detemir titration targets in type 2 diabetes
NCT00634842Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2008
- Primary completion
- Oct 2008
- Countries
- 2
- Sponsor
- Novo Nordisk
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- insulin detemir
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, randomised, open-label trial of insulin detemir in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Novo Nordisk. Primary endpoint: Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% at 20 weeks. Started Feb 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Aggressive Target (70-90 mg/dL)
Insulin detemir titrated to FPG 70-90 mg/dL
Conventional Target (80-110 mg/dL)
Insulin detemir titrated to FPG 80-110 mg/dL
03
Who it enrols
Insulin-naive patients with Type 2 diabetes on 1-3 oral treatments with HbA1c 7.0-9.0% and BMI <= 45 kg/m^2.
04
Endpoints
Primary
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
Secondary
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
05
Results
Primary endpoints met
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