Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes (DIET™)
Diabetes, Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start
- Insulin naive subjects
- HbA1c: 7.0-9.0 % (both inclusive)
- Body Mass Index (BMI): 25.0-45.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Use of Thiazolidinedione (TZDs) or Glucagon-like peptide-1 analogue (GLP- 1) receptor agonists within the last 3 months prior to trial enrollment
- Cardiovascular disease within the last 6 months
- Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- Uncontrolled treated/untreated severe hypertension, impaired liver function, impaired renal function, known proliferative retinopathy or maculopathy requiring treatment
- Cancer and medical history of cancer in the past 5 years (except basal cell skin cancer or squamous cell skin cancer)
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Sites / Locations
- Novo Nordisk Investigational Site
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Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control
Dietician
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.