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Completed

NCT Number: NCT00788840

Detemir Energy Expenditure Study

This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cedar Centre, Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Treated with metformin
  • Already on treatment with a long-acting or intermediate insulin.
  • Over 18 years of age,
  • HbA1c > 7.0%
  • BMI 27-40
  • Able and willing to perform self-blood glucose monitoring.
  • Able and willing to maintain consistent eating habits throughout the entire trial period.
  • Able and willing to maintain consistent physical activity level during the entire trial period

Exclusion criteria

  • Patients on sulphonylureas or thiazolidinediones
  • Proliferative retinopathy that has required acute treatment within the last six months.
  • Impaired hepatic or renal functions.
  • Cardiac problems.
  • Uncontrolled hypertension (treated or untreated).
  • Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.

Treatment and study plan

Insulatard

Drug

Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.

Detemir

Drug

Detemir insulin used as long-acting insulin in treatment phase of study.

Other names: Levemir

Primary outcomes

  1. Weight change

    Time frame: 6 months

Secondary outcomes

  1. Energy Expenditure

    Time frame: 6 months

  2. Fat composition

    Time frame: 6 months

  3. Fat & muscle gene expression

    Time frame: 6 months

  4. Glycaemic control

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabetes

Acronym: DEES

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2008
Registry last updated
May 31, 2023

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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