The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455441
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Tina Vilsboll, University Hospital, Gentofte, Copenhagen

Brief Summary:

The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.

Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Training and liraglutide Other: Training and placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?
Study Start Date : October 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Training and liraglutide
Treatment with both training and liraglutide for 16 weeks
Other: Training and liraglutide
Placebo Comparator: Training and placebo
Treatment wiht both training and placebo for 16 weeks
Other: Training and placebo

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 16 weeks ]
    Change in HbA1c from baseline to 16 weeks. Glycated haemoglobin (HbA1c) is a form of haemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time (12 weeks).

Secondary Outcome Measures :
  1. Maximal oxygen uptake (VO2peak) [ Time Frame: 16 weeks ]
    Changes in VO2peak from baseline to 16 weeks

  2. Body weight [ Time Frame: 16 weeks ]
    Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan

  3. Blood pressure [ Time Frame: 16 weeks ]
    Changes in blood pressure from baseline to 16 weeks

  4. Glycaemic control [ Time Frame: 16 weeks ]
    Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response

  5. Meal test [ Time Frame: 16 weeks ]
    The changes in the postprandial response of incretin hormones, insulin and glucose, glucagon and the microvascular blood flow will be evaluated. Changes in blood leves of triglycerides and cholesterol.

  6. Myocardial echocardiography [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed oral and written consent
  • Diagnosed with type 2 diabetes according to the criteria of the WHO
  • HbA1C: 7-11% (doing treatment with diet and/or metformin)
  • Age >18 years
  • BMI >25 kg/m2 <40 kg/m2
  • Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies

Exclusion Criteria:

  • Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures.
  • Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones
  • Ongoing abuse of alcohol or narcotics
  • Impaired hepatic function (liver transaminases >2 times upper normal limit)
  • Impaired renal function (se-creatinine >150μM and/or albuminuria)
  • Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
  • Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
  • Anaemia
  • Any condition that the investigators feels would interfere with trial participation
  • Receiving any investigational drug within the last 3 months

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 identifier (NCT number): NCT01455441

Department of Internal Medicine, Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Tina Vilsboll

Responsible Party: Tina Vilsboll, Professor, University Hospital, Gentofte, Copenhagen Identifier: NCT01455441     History of Changes
Other Study ID Numbers: 60 - TrainIncretin
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Tina Vilsboll, University Hospital, Gentofte, Copenhagen:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists