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

Tina Vilsboll

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Other: Training and placebo; Other: Training and liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT01455441

60 - TrainIncretin

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Training and liraglutide

Active Comparator group

Description:

Treatment with both training and liraglutide for 16 weeks

Treatment:

Other: Training and liraglutide

Training and placebo

Placebo Comparator group

Description:

Treatment wiht both training and placebo for 16 weeks

Treatment:

Other: Training and placebo