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Completed

NCT Number: NCT01232491

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

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.

Dietary regimen

Dietary Supplement

Subjects receive dietary consultation by a dietician at six occasions during the trial.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: DIET™

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2010
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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