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

Type 2 Diabetes Clinical Trial

Official title:

Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455441
• Other study ID #: 60 - TrainIncretin
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2011
• Last updated: May 28, 2015
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Training and liraglutide

• Training and placebo

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine, Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Tina Vilsboll

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	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).	16 weeks	No
Secondary	Maximal oxygen uptake (VO2peak)	Changes in VO2peak from baseline to 16 weeks	16 weeks	No
Secondary	Body weight	Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan	16 weeks	No
Secondary	Blood pressure	Changes in blood pressure from baseline to 16 weeks	16 weeks	No
Secondary	Glycaemic control	Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response	16 weeks	No
Secondary	Meal test	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.	16 weeks	No
Secondary	Myocardial echocardiography		16 weeks	No