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Levemir DIET: Dietary Intervention in Type 2 Diabetes
NCT01232491Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2010
- Primary completion
- Nov 2011
- Countries
- 11
- 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: Change From Baseline in Body Weight at 26 weeks. Started Oct 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Control
Insulin detemir + Metformin + basic dietary advice
Dietician
Insulin detemir + Metformin + 6 dietician consultations (3 face-to-face, 3 phone)
03
Who it enrols
Insulin-naive patients with type 2 diabetes (HbA1c 7.0-9.0%) and BMI 25.0-45.0 kg/m^2, inadequately controlled on metformin.
04
Endpoints
Primary
Change From Baseline in Body Weight
Secondary
Change From Baseline in Body Mass Index
Change From Baseline in Glycosylated Haemoglobin
Change From Baseline in Fasting Plasma Glucose
Rate of Treatment Emergent Adverse Events
Rate of All Treatment Emergent Hypoglycaemic Episodes
Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes
05
Results
Not all primary endpoints met
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