Diabetes MellitusPhase 2/3NCT00993720
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
A Phase 2/3 study testing Liraglutide and continuous insulin therapy in people with Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Liraglutide and continuous insulin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-50y,
- BMI 18-27,
- caucasian origin,
- type 1 diabetes diagnosed between age 5 and age 40,
- no known diabetes complications or cardiovascular diseases,
- no medication known to influence glucose homeostasis,
- no pregnancy
Who cannot join
- diabetes complications,
- autonomous nerve dysfunction,
- anaemia,
- HbA1c < 8.5% at screening,
- estimated by the investigator to be incapable of completing the trial.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- Liraglutide, continuous insulin therapy
- Keywords
- patients with type 1 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.
LiraglutideDrug
after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.
continuous insulin therapyOther
after optimal treatment with insulin, patients continue on insulin for four weeks
| Study group | Role | What they receive |
|---|---|---|
| type 1 DM with betacell function: Liraglutide | Experimental | Not described Receives: Drug: Liraglutide |
| type 1 DM without betacell function: Liraglutide | Experimental | Not described Receives: Drug: Liraglutide |
| type 1 DM without betacell function: Insulin | No intervention | Not described Receives: Other: continuous insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin-dose
Measured: 4 weeks
Secondary outcomes (4)
24-hours glucose profiles with and without treatment of Victoza
Measured: three days
risk of hypoglycemia during physical activity with and without Victoza
Measured: one day
gastric emptying rate during hypoglycemia with and without Victoza
Measured: one day
weight change from baseline, change in fructosamine from baseline
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993720
- Sponsor's protocol ID
- 2009-001930-80
- Other IDs
- 2009
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 21 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kielgast U, Krarup T, Holst JJ, Madsbad S. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care. 2011 Jul;34(7):1463-8. doi: 10.2337/dc11-0096. Epub 2011 May 18.
PubMed 21593296
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00993720
- Acronym / sponsor ID
- 2009-001930-80
- Conditions
- Diabetes Mellitus
- Keywords
- patients with type 1 diabetes mellitus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 Oct 2009 (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 aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 1 DM with betacell function: Liraglutide | Experimental | Drug: Liraglutide |
| type 1 DM without betacell function: Liraglutide | Experimental | Drug: Liraglutide |
| type 1 DM without betacell function: Insulin | No intervention | Other: continuous insulin therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 18-50y,
- BMI 18-27,
- caucasian origin,
- type 1 diabetes diagnosed between age 5 and age 40,
- no known diabetes complications or cardiovascular diseases,
Key exclusion criteria (5 listed)
- diabetes complications,
- autonomous nerve dysfunction,
- anaemia,
- HbA1c < 8.5% at screening,
- estimated by the investigator to be incapable of completing the trial.
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 |
|---|---|---|
| Liraglutideafter optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day. | Drug | type 1 DM with betacell function: Liraglutide |
| Liraglutideafter optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day. | Drug | type 1 DM without betacell function: Liraglutide |
| continuous insulin therapyafter optimal treatment with insulin, patients continue on insulin for four weeks | Other | type 1 DM without betacell function: Insulin |
Primary outcome
insulin-dose
Time frame: 4 weeks
4 secondary outcomes
24-hours glucose profiles with and without treatment of Victoza
Time frame: three days
risk of hypoglycemia during physical activity with and without Victoza
Time frame: one day
gastric emptying rate during hypoglycemia with and without Victoza
Time frame: one day
weight change from baseline, change in fructosamine from baseline
Time frame: four 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 21 Jan 2011.
- Derived from this study: PubMed 21593296Kielgast U, Krarup T, Holst JJ, Madsbad S. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care. 2011 Jul;34(7):1463-8. doi: 10.2337/dc11-0096. Epub 2011 May 18.
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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 2/3 study testing Liraglutide and continuous insulin therapy in people with Diabetes Mellitus, run by Hvidovre University Hospital 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 7 inclusion and 5 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 21 Jan 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
insulin-dose (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993720, which also lists 1 linked publication.
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 21 Jan 2011.