Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-11-14
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Metformin

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