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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tina Vilsboll, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01455441
First received: October 19, 2011
Last updated: December 13, 2013
Last verified: December 2013

October 19, 2011
December 13, 2013
October 2011
June 2013   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01455441 on ClinicalTrials.gov Archive Site
  • Maximal oxygen uptake (VO2peak) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes in VO2peak from baseline to 16 weeks
  • Body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan
  • Blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes in blood pressure from baseline to 16 weeks
  • Glycaemic control [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response
  • Meal test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.
  • Myocardial echocardiography [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Other: Training and liraglutide
  • Other: Training and placebo
  • Active Comparator: Training and liraglutide
    Treatment with both training and liraglutide for 16 weeks
    Intervention: Other: Training and liraglutide
  • Placebo Comparator: Training and placebo
    Treatment wiht both training and placebo for 16 weeks
    Intervention: Other: Training and placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
June 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01455441
60 - TrainIncretin
Yes
Tina Vilsboll, University Hospital, Gentofte, Copenhagen
Tina Vilsboll
Not Provided
Not Provided
University Hospital, Gentofte, Copenhagen
December 2013

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