Type 2 DiabetesPhase 4NCT01455441
The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
A Phase 4 study testing Training and liraglutide in people with Type 2 Diabetes, run by Tina Vilsboll at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Training and liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine, Gentofte Hospital
Hellerup, 2900
About this study
Official title: Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Training and liraglutide, Training and placebo
- Keywords
- GLP-1, Training, Exercise, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and liraglutideOther
Training and placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Training and liraglutide | Active comparator | Treatment with both training and liraglutide for 16 weeks Receives: Other: Training and liraglutide |
| Training and placebo | Placebo comparator | Treatment wiht both training and placebo for 16 weeks Receives: Other: Training and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16 weeks
Secondary outcomes (6)
Maximal oxygen uptake (VO2peak)
Changes in VO2peak from baseline to 16 weeks
Measured: 16 weeks
Body weight
Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan
Measured: 16 weeks
Blood pressure
Changes in blood pressure from baseline to 16 weeks
Measured: 16 weeks
Glycaemic control
Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response
Measured: 16 weeks
Meal test
The changes in the postprandial response of incretin hormones, insulin and glucose, glucagon and the microvascular blood flow will be evaluated. Changes in blood leves of triglycerides and cholesterol.
Measured: 16 weeks
Myocardial echocardiography
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tina Vilsboll
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tina Vilsboll, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455441
- Sponsor's protocol ID
- 60 - TrainIncretin
- Status last verified
- May 2015
- First submitted
- 19 Oct 2011
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?
- ClinicalTrials.gov ID
- NCT01455441
- Acronym / sponsor ID
- 60 - TrainIncretin
- Conditions
- Type 2 Diabetes
- Keywords
- GLP-1, Training, Exercise, Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tina VilsbollUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training and liraglutide | Active comparator | Other: Training and liraglutideTreatment with both training and liraglutide for 16 weeks |
| Training and placebo | Placebo comparator | Other: Training and placeboTreatment wiht both training and placebo for 16 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training and liraglutide | Other | Training and liraglutide |
| Training and placebo | Other | Training and placebo |
Primary outcome
HbA1c
Time frame: 16 weeks
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).
6 secondary outcomes
Maximal oxygen uptake (VO2peak)
Time frame: 16 weeks
Body weight
Time frame: 16 weeks
Blood pressure
Time frame: 16 weeks
Glycaemic control
Time frame: 16 weeks
Meal test
Time frame: 16 weeks
Myocardial echocardiography
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Training and liraglutide in people with Type 2 Diabetes, run by Tina Vilsboll at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.