Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes (DIET™)

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Dietary regimen; Drug: Insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232491

U1111-1116-2629 (Other Identifier)

2009-014894-42 (EudraCT Number)

NN304-3785

Details and patient eligibility

About

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).

Enrollment: 611 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

611 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin detemir

Dietician

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary regimen

Drug: Insulin detemir