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

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ClinicalTrials.gov Identifier: NCT01232491
Recruitment Status : Completed
First Posted : November 2, 2010
Results First Posted : December 11, 2012
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Insulin detemir Dietary Supplement: Dietary regimen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 611 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : October 29, 2010
Actual Primary Completion Date : November 1, 2011
Actual Study Completion Date : November 14, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232491


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Locations
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United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35233
Novo Nordisk Investigational Site
Ozark, Alabama, United States, 36360
United States, California
Novo Nordisk Investigational Site
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
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Novo Nordisk Investigational Site
Norwalk, Connecticut, United States, 06851
United States, Florida
Novo Nordisk Investigational Site
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
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30342
Novo Nordisk Investigational Site
Perry, Georgia, United States, 31069
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Investigational Site
Oympiafields, Illinois, United States, 60641
United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47714
United States, Kansas
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, United States, 66204
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40213
United States, Maine
Novo Nordisk Investigational Site
Portland, Maine, United States, 04101
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Brockton, Massachusetts, United States, 02301
United States, Michigan
Novo Nordisk Investigational Site
Buckley, Michigan, United States, 49620
Novo Nordisk Investigational Site
Southfield, Michigan, United States, 48034
United States, Missouri
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
Novo Nordisk Investigational Site
Berlin, New Jersey, United States, 08009
United States, New York
Novo Nordisk Investigational Site
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
United States, North Carolina
Novo Nordisk Investigational Site
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
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45245
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45406
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104-5020
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Jenkintown, Pennsylvania, United States, 19046
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States, 19401
United States, South Carolina
Novo Nordisk Investigational Site
Anderson, South Carolina, United States, 29621
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, South Dakota
Novo Nordisk Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Novo Nordisk Investigational Site
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
United States, Texas
Novo Nordisk Investigational Site
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
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Plano, Texas, United States, 75075
United States, Utah
Novo Nordisk Investigational Site
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23502
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23249
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23294
Novo Nordisk Investigational Site
Winchester, Virginia, United States, 22601
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99208
United States, West Virginia
Novo Nordisk Investigational Site
Martinsburg, West Virginia, United States, 25401
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Argentina
Novo Nordisk Investigational Site
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
Germany
Novo Nordisk Investigational Site
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
Poland
Novo Nordisk Investigational Site
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
Puerto Rico
Novo Nordisk Investigational Site
Carolina, Puerto Rico, 00983
Novo Nordisk Investigational Site
Manati, Puerto Rico, 00674
Russian Federation
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194358
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 195213
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 199034
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 851 01
Novo Nordisk Investigational Site
Kosice, Slovakia, 04-001
Novo Nordisk Investigational Site
Lubochna, Slovakia, 03491
Slovenia
Novo Nordisk Investigational Site
Koper, Slovenia, SI-6000
Novo Nordisk Investigational Site
Maribor, Slovenia, 2000
Novo Nordisk Investigational Site
Novo mesto, Slovenia, 8000
Spain
Novo Nordisk Investigational Site
Málaga, Spain, 29006
Novo Nordisk Investigational Site
Málaga, Spain, 29009
Novo Nordisk Investigational Site
Sanlúcar de Barrameda, Spain, 11540
Turkey
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry Gorsøe (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01232491     History of Changes
Other Study ID Numbers: NN304-3785
U1111-1116-2629 ( Other Identifier: WHO )
2009-014894-42 ( EudraCT Number )
First Posted: November 2, 2010    Key Record Dates
Results First Posted: December 11, 2012
Last Update Posted: May 1, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight Changes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Insulin
Insulin, Globin Zinc
Metformin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs