A 26-week randomised, controlled, open label, multicentre, multinational, treat to target trial investigating the impact of dietary intervention on weight change and the relationship between weight change and baseline body mass index (BMI) in subjects with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs) initiating insulin therapy with insulin detemir in combination with metformin - Levemir® DIET™

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

• Type 2 diabetes (diagnosed clinically) for = 6 months prior to screening
• Insulin naive subjects
• Current treatment: metformin monotherapy or metformin in any combination with the following OADs: insulin secretagogue (SU or glinide), DPP-4 inhibitor, a-glucosidase-inhibitors (acarbose), all with an unchanged total daily dosing for at least 3 months prior to screening
• HbA1c 7.0-9.0 % (both inclusive) at screening by central laboratory analysis
• BMI 25.0-45.0 kg/m2 (both inclusive) measured at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Use of: TZDs or Glucagon-like peptide-1 analogue (GLP-1) receptor agonists within the last 3 months prior to Visit 1
• Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO inhibitors)
• Anticipated initiation or change in concomitant medication known to affect weight, such as weight loss/modifying medication (e.g. sibutramine, orlistat, thyroid hormones), steroids (e.g. corticosteroids, progesterone, testosterone) and diuretics
• Any conditions that the investigator judges would interfere with trial participation or evaluation of the results
• Known or suspected allergy to insulin detemir or related products

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if treat-to-target treatment with insulin detemir once-daily (OD) combined with metformin accompanied with dietary intervention is superior to treat-to-target treatment with insulin detemir OD combined with metformin without dietary intervention with respect to weight change after 26 weeks of treatment in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other OADs.;Secondary Objective: • To investigate the association between weight change at 26 weeks and baseline BMI<br>• To assess and compare efficacy after 26 weeks of treatment<br>• To assess and compare safety and tolerability after 26 weeks of treatment;Primary end point(s): Weight change from baseline to end of the treatment period

Secondary Outcome Measures