Diabetes type 2 MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza(R)
Pharmaceutical Form: Suspension for injection in pre-filled pen
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use
Sponsors
Dr. med. Tina Vilsbøll
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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) XML File Identifier: POxD9P5KKuNPnWUv/kBDFfkMsD0= Page 10/19 •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: ;Primary end point(s): The primary endpoint is the change from baseline in HbA1c.;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include changes in VO2max, body weight, blood pressure, overall glycaemic control parameters, insulin sensitivity and beta cell function (evaluated by HOMA), cholesterol and triglycerides, DEXA scanning (body composition). In a subgroup of the included paticipants, the changes in the postprandielle respons of incretinhormones, insulin and glucose and the microvaskular bloodflow will be evaluatede. For the muscle- and fatbiopsis asesses the quantity of glucosetransportors, mitochondrieenzyms, enzyms in the insulins signaltransduction pathway and the nitrogenoxidsynthase. ;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Countries
Denmark
Contacts
Public ContactDepartment of Internal Medicine F
Dr. med. Tina Vilsbøll
Outcome results
None listed