NCT01455441

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Oct 2011

Typical duration for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

October 19, 2011

Last Update Submit

May 28, 2015

Conditions

Type 2 Diabetes

Keywords

GLP-1TrainingExerciseType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change in HbA1c from baseline to 16 weeks. Glycated haemoglobin (HbA1c) is a form of haemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time (12 weeks).

    16 weeks

Secondary Outcomes (6)

  • Maximal oxygen uptake (VO2peak)

    16 weeks

  • Body weight

    16 weeks

  • Blood pressure

    16 weeks

  • Glycaemic control

    16 weeks

  • Meal test

    16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Training and liraglutide

ACTIVE COMPARATOR

Treatment with both training and liraglutide for 16 weeks

Other: Training and liraglutide

Training and placebo

PLACEBO COMPARATOR

Treatment wiht both training and placebo for 16 weeks

Other: Training and placebo

Interventions

Training and liraglutideOTHER
Training and liraglutide
Training and placeboOTHER
Training and placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor dr.med

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 20, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

DK(1)