Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes - Full Text View

Purpose

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).

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin detemir Dietary Supplement: dietary regimen	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Insulin human Insulin detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change From Baseline in Body Weight [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Estimated mean change from baseline in body weight after 26 weeks of treatment.

Secondary Outcome Measures:

Change From Baseline in Body Mass Index (BMI) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Estimated mean change from baseline in BMI after 26 weeks of treatment.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Estimated mean change from baseline in FPG after 26 weeks of treatment.
Rate of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
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.
Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
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.

Enrollment:	611
Study Start Date:	October 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control 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.	Drug: insulin detemir Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.
Experimental: Dietician 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.	Drug: insulin detemir Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment. Dietary Supplement: dietary regimen Subjects receive dietary consultation by a dietician at six occasions during the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232491

Show 84 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Berit Gorsøe Kjeldsen

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01232491 History of Changes
Other Study ID Numbers:	NN304-3785, U1111-1116-2629, 2009-014894-42
Study First Received:	October 29, 2010
Results First Received:	November 14, 2012
Last Updated:	January 2, 2013
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Germany: Federal Institute for Drugs and Medical Devices Serbia: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health Spain: Spanish Agency of Medicines and Health Care Products Turkey: Ministry of Health Poland: Ministry of Health United States: Food and Drug Administration

Additional relevant MeSH terms:

Body Weight Changes
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Insulin
Hypoglycemic Agents
Metformin
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

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