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

Phase 4

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: Insulin detemir
Dietary Supplement: Dietary regimen

Registration Number: NCT01232491

Lead Sponsor: Novo Nordisk A/S

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 611

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Insulin detemir	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.
Dietician	Insulin detemir	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.
Dietician	Dietary regimen	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Week 0, Week 26	Estimated mean change from baseline in body weight after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Mass Index (BMI)	Week 0, Week 26	Estimated mean change from baseline in BMI after 26 weeks of treatment.
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Week 0, Week 26	Estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Change From Baseline in Fasting Plasma Glucose (FPG)	Week 0, Week 26	Estimated mean change from baseline in FPG after 26 weeks of treatment.
Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes	Week 0 to Week 26	Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.
Rate of Treatment Emergent Adverse Events (TEAEs)	Week 0 to Week 26	Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Rate of All Treatment Emergent Hypoglycaemic Episodes	Week 0 to Week 26	Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.