E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change from baseline in HbA1c. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of 16 weeks for the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |