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NCT01232491 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— DIET™  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01232491
Other study ID # NN304-3785
Secondary ID U1111-1116-26292
Status Completed
Phase Phase 4
First received October 29, 2010
Last updated January 2, 2013
Start date October 2010
Est. completion date November 2011

Study information
Verified date January 2013
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaGermany: Federal Institute for Drugs and Medical DevicesSerbia: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of HealthSpain: Spanish Agency of Medicines and Health Care ProductsTurkey: Ministry of HealthPoland: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 611
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Puerto Rico Novo Nordisk Clinical Trial Call Center Carolina
Puerto Rico Novo Nordisk Clinical Trial Call Center Manati
United States Novo Nordisk Clinical Trial Call Center Altoona Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Anaheim California
United States Novo Nordisk Clinical Trial Call Center Anderson South Carolina
United States Novo Nordisk Clinical Trial Call Center Berlin New Jersey
United States Novo Nordisk Clinical Trial Call Center Birmingham Alabama
United States Novo Nordisk Clinical Trial Call Center Bradenton Florida
United States Novo Nordisk Clinical Trial Call Center Bristol Tennessee
United States Novo Nordisk Clinical Trial Call Center Brockton Massachusetts
United States Novo Nordisk Clinical Trial Call Center Buckley Michigan
United States Novo Nordisk Clinical Trial Call Center Burlingame California
United States Novo Nordisk Clinical Trial Call Center Charlotte North Carolina
United States Novo Nordisk Clinical Trial Call Center Chattanooga Tennessee
United States Novo Nordisk Clinical Trial Call Center Chino California
United States Novo Nordisk Clinical Trial Call Center Cincinnati Ohio
United States Novo Nordisk Clinical Trial Call Center Clearwater Florida
United States Novo Nordisk Clinical Trial Call Center Colorado Springs Colorado
United States Novo Nordisk Clinical Trial Call Center Concord California
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Dayton Ohio
United States Novo Nordisk Clinical Trial Call Center Dayton Ohio
United States Novo Nordisk Clinical Trial Call Center Durham North Carolina
United States Novo Nordisk Clinical Trial Call Center Evansville Indiana
United States Novo Nordisk Clinical Trial Call Center Greer South Carolina
United States Novo Nordisk Clinical Trial Call Center Jacksonville Florida
United States Novo Nordisk Clinical Trial Call Center Jenkintown Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Jupiter Florida
United States Novo Nordisk Clinical Trial Call Center Kingsport Tennessee
United States Novo Nordisk Clinical Trial Call Center Long Beach California
United States Novo Nordisk Clinical Trial Call Center Long Beach California
United States Novo Nordisk Clinical Trial Call Center Louisville Kentucky
United States Novo Nordisk Clinical Trial Call Center Martinsburg West Virginia
United States Novo Nordisk Clinical Trial Call Center Miami Florida
United States Novo Nordisk Clinical Trial Call Center Milwaukee Wisconsin
United States Novo Nordisk Clinical Trial Call Center Nashville Tennessee
United States Novo Nordisk Clinical Trial Call Center National City California
United States Novo Nordisk Clinical Trial Call Center New York New York
United States Novo Nordisk Clinical Trial Call Center Norfolk Virginia
United States Novo Nordisk Clinical Trial Call Center Norristown Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Northport New York
United States Novo Nordisk Clinical Trial Call Center Norwalk Connecticut
United States Novo Nordisk Clinical Trial Call Center Odessa Texas
United States Novo Nordisk Clinical Trial Call Center Oklahoma City Oklahoma
United States Novo Nordisk Clinical Trial Call Center Oklahoma City Oklahoma
United States Novo Nordisk Clinical Trial Call Center Oympiafields Illinois
United States Novo Nordisk Clinical Trial Call Center Ozark Alabama
United States Novo Nordisk Clinical Trial Call Center Pembroke Pines Florida
United States Novo Nordisk Clinical Trial Call Center Pembroke Pines Florida
United States Novo Nordisk Clinical Trial Call Center Pembroke Pines Florida
United States Novo Nordisk Clinical Trial Call Center Perry Georgia
United States Novo Nordisk Clinical Trial Call Center Plano Texas
United States Novo Nordisk Clinical Trial Call Center Portland Maine
United States Novo Nordisk Clinical Trial Call Center Raleigh North Carolina
United States Novo Nordisk Clinical Trial Call Center Rapid City South Dakota
United States Novo Nordisk Clinical Trial Call Center Redlands California
United States Novo Nordisk Clinical Trial Call Center Richmond Virginia
United States Novo Nordisk Clinical Trial Call Center Richmond Virginia
United States Novo Nordisk Clinical Trial Call Center Rockville Maryland
United States Novo Nordisk Clinical Trial Call Center Roswell Georgia
United States Novo Nordisk Clinical Trial Call Center Santa Ana California
United States Novo Nordisk Clinical Trial Call Center Shawnee Mission Kansas
United States Novo Nordisk Clinical Trial Call Center Southfield Michigan
United States Novo Nordisk Clinical Trial Call Center Spokane Washington
United States Novo Nordisk Clinical Trial Call Center Spring Valley California
United States Novo Nordisk Clinical Trial Call Center St. George Utah
United States Novo Nordisk Clinical Trial Call Center St. Louis Missouri
United States Novo Nordisk Clinical Trial Call Center Tipton Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Topeka Kansas
United States Novo Nordisk Clinical Trial Call Center Walnut Creek California
United States Novo Nordisk Clinical Trial Call Center West Seneca New York
United States Novo Nordisk Clinical Trial Call Center Wilmington North Carolina
United States Novo Nordisk Clinical Trial Call Center Winchester Virginia

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Germany,  Poland,  Puerto Rico,  Serbia,  Slovakia,  Slovenia,  Spain,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Body Weight Estimated mean change from baseline in body weight after 26 weeks of treatment. Week 0, Week 26 No
Secondary Change From Baseline in Body Mass Index (BMI) Estimated mean change from baseline in BMI after 26 weeks of treatment. Week 0, Week 26 No
Secondary Change From Baseline in Glycosylated Haemoglobin (HbA1c) Estimated mean change from baseline in HbA1c after 26 weeks of treatment. Week 0, Week 26 No
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) Estimated mean change from baseline in FPG after 26 weeks of treatment. Week 0, Week 26 No
Secondary 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. Week 0 to Week 26 No
Secondary 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. Week 0 to Week 26 No
Secondary Rate of Nocturnal 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. 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. Week 0 to Week 26 No
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