Status:
COMPLETED
The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
Lead Sponsor:
Tina Vilsboll
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01455441
Start Date
October 1 2011
End Date
June 1 2014
Last Update
May 29 2015
Active Locations (1)
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1
Department of Internal Medicine, Gentofte Hospital
Hellerup, Denmark, 2900