Does the GLP-1 like-hormone (Victoza®) improve the glycemic control to physical training in patients with type 2 diabetes?

• Conditions: Diabetes type 2; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2011-002739-24-DK
• Lead Sponsor: Dr. med. Tina Vilsbøll

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-26
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Informed oral and written consent
•Diagnosed with type 2 diabetes according to the criteria of the WHO
(see appendix 5)
•HbA1C: 7-10% (doing treatment with diet and/or metformin)
•Age >18 years
•BMI >25 kg/m2 <35 kg/m2
•Negative islet cell antibodies (ICA) and glutamatsyre decarboxylase 65
(GAD-65) autoantibodies
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 sulfonylurinstof, dipeptidyl peptidase 4 (DPP-4)
inhibitors, insulin or glitazoner
•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)
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•Cardic problems defined as decompensated heart failure (NYHA class
III or IV), unstable angina pectoris and/or myocardial infarction within
the last 12 months (see appendix 6)
•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
•Compliance <80% to training

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified