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

March 28, 2017 updated by: Novo Nordisk A/S

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

611

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1636DSU
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1419AHN
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, 1429
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, 5000
        • Novo Nordisk Investigational Site
      • Godoy Cruz, Argentina, M5501ARP
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Neuenahr-Ahrweiler, Germany, 53474
        • Novo Nordisk Investigational Site
      • Gelnhausen, Germany, 63571
        • Novo Nordisk Investigational Site
      • Mainz, Germany, 55116
        • Novo Nordisk Investigational Site
      • Marburg, Germany, 35039
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-445
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-044
        • Novo Nordisk Investigational Site
      • Torun, Poland, 87-100
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-911
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Novo Nordisk Investigational Site
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 195213
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 199034
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 04-001
        • Novo Nordisk Investigational Site
      • Lubochna, Slovakia, 03491
        • Novo Nordisk Investigational Site
  • Slovenia
      • Koper, Slovenia, SI-6000
        • Novo Nordisk Investigational Site
      • Maribor, Slovenia, 2000
        • Novo Nordisk Investigational Site
      • Novo mesto, Slovenia, 8000
        • Novo Nordisk Investigational Site
  • Spain
      • Málaga, Spain, 29006
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29009
        • Novo Nordisk Investigational Site
      • Sanlúcar de Barrameda, Spain, 11540
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06110
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34096
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34098
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34722
        • Novo Nordisk Investigational Site
      • Samsun, Turkey, 55139
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Novo Nordisk Investigational Site
      • Ozark, Alabama, United States, 36360
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Burlingame, California, United States, 94010
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Fullerton, California, United States, 92835
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90806
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90807
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90822
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • National City, California, United States, 91950
        • Novo Nordisk Investigational Site
      • Redlands, California, United States, 92374
        • Novo Nordisk Investigational Site
      • Santa Ana, California, United States, 92705
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Novo Nordisk Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33765
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Jupiter, Florida, United States, 33458
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33135
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33029
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Novo Nordisk Investigational Site
      • Perry, Georgia, United States, 31069
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Illinois
      • Oympiafields, Illinois, United States, 60641
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Novo Nordisk Investigational Site
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
    • Maine
      • Portland, Maine, United States, 04101
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Novo Nordisk Investigational Site
      • Southfield, Michigan, United States, 48034
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, United States, 10025
        • Novo Nordisk Investigational Site
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • Durham, North Carolina, United States, 27710
        • Novo Nordisk Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Novo Nordisk Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novo Nordisk Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104-5020
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Novo Nordisk Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620-7352
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75251
        • Novo Nordisk Investigational Site
      • Odessa, Texas, United States, 79761
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75075
        • Novo Nordisk Investigational Site
    • Utah
      • St. George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23294
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23249
        • Novo Nordisk Investigational Site
      • Winchester, Virginia, United States, 22601
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Novo Nordisk Investigational Site
    • West Virginia
      • Martinsburg, West Virginia, United States, 25401
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight
Time Frame: Week 0, Week 26
Estimated mean change from baseline in body weight after 26 weeks of treatment.
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Mass Index (BMI)
Time Frame: Week 0, Week 26
Estimated mean change from baseline in BMI after 26 weeks of treatment.
Week 0, Week 26
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 26
Estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Week 0, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, Week 26
Estimated mean change from baseline in FPG after 26 weeks of treatment.
Week 0, Week 26
Rate of Treatment Emergent Adverse Events (TEAEs)
Time Frame: 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.
Week 0 to Week 26
Rate of All Treatment Emergent Hypoglycaemic Episodes
Time Frame: 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.
Week 0 to Week 26
Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes
Time Frame: 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.
Week 0 to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry Gorsøe (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 14, 2011

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3785
  • U1111-1116-2629 (Other Identifier: WHO)
  • 2009-014894-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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