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

Novo Nordisk A/S611 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

611

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

Insulin detemirDRUG

Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.

Dietary regimenDIETARY_SUPPLEMENT

Subjects receive dietary consultation by a dietician at six occasions during the trial.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (112)

Outcomes

Primary Outcomes

Change From Baseline in Body Weight

Estimated mean change from baseline in body weight after 26 weeks of treatment.

Time frame: Week 0, Week 26

Secondary Outcomes

Change From Baseline in Body Mass Index (BMI)

Estimated mean change from baseline in BMI after 26 weeks of treatment.

Time frame: Week 0, Week 26

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Estimated mean change from baseline in HbA1c after 26 weeks of treatment.

Time frame: Week 0, Week 26

Change From Baseline in Fasting Plasma Glucose (FPG)

Estimated mean change from baseline in FPG after 26 weeks of treatment.

Time frame: Week 0, Week 26

Rate of Treatment Emergent Adverse Events (TEAEs)

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.

Time frame: Week 0 to Week 26

Rate of All Treatment Emergent Hypoglycaemic Episodes

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.

Data from ClinicalTrials.gov

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