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

NCT ID: NCT01455441

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Training and liraglutide

Treatment with both training and liraglutide for 16 weeks

Group Type ACTIVE_COMPARATOR

Training and liraglutide

Intervention Type OTHER

Training and placebo

Treatment wiht both training and placebo for 16 weeks

Group Type PLACEBO_COMPARATOR

Training and placebo

Intervention Type OTHER

Interventions

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Training and liraglutide

Intervention Type OTHER

Training and placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tina Vilsboll

OTHER

Sponsor Role lead

Responsible Party

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Tina Vilsboll

Professor dr.med

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Internal Medicine, Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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60 - TrainIncretin

Identifier Type: -

Identifier Source: org_study_id

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