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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

Tracking Information
First Submitted Date  ICMJE October 29, 2010
First Posted Date  ICMJE November 2, 2010
Results First Submitted Date  ICMJE November 14, 2012
Results First Posted Date  ICMJE December 11, 2012
Last Update Posted Date May 1, 2017
Actual Study Start Date  ICMJE October 29, 2010
Actual Primary Completion Date November 1, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
Weight change [ Time Frame: Week 0, Week 26 ]
Change History Complete list of historical versions of study NCT01232491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
  • Change in BMI (Body Mass Index) [ Time Frame: Week 0, Week 26 ]
  • Change in HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 0, Week 26 ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: Week 0, Week 26 ]
  • Number of Adverse events (AEs) [ Time Frame: weeks 0-26 ]
  • Number of hypoglycaemic episodes [ Time Frame: weeks 0-26 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Insulin detemir
  • 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.
    Interventions:
    • Drug: Insulin detemir
    • Dietary Supplement: Dietary regimen
Publications * Niswender K, Piletic M, Andersen H, Conradsen Hiort L, Hollander P. Weight change upon once-daily initiation of insulin detemir with or without dietary intervention in overweight or obese insulin-naïve individuals with type 2 diabetes: results from the DIET trial. Diabetes Obes Metab. 2014 Feb;16(2):186-92. doi: 10.1111/dom.12218. Epub 2013 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2011)
611
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2010)
600
Actual Study Completion Date  ICMJE November 14, 2011
Actual Primary Completion Date November 1, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Germany,   Poland,   Puerto Rico,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01232491
Other Study ID Numbers  ICMJE NN304-3785
U1111-1116-2629 ( Other Identifier: WHO )
2009-014894-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry Gorsøe (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP