DiabetesPhase 2NCT00154401
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
A Phase 2 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 39 sites in 4 countries.
Trial summary
This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide
- How many people
- 177 participants
- Where
- 39 sitesin 4 countries
- Study dates
- Jan 2005to Oct 2005
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
- Diet treated subjects: 7.5% < HbA1c < 10%
- Single oral drug therapy subjects: 7.0% < HbA1c < 9.5%
- Body Mass Index (BMI): max 40 kg/m^2
Who cannot join
- Subjects treated with thiazolidinediones or insulin
- Subjects with any serious medical conditions
Trial locations and contacts
39 sites in 4 countries.
39 sites in 4 countries
France12 sites
Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Dax, 40107
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Marseille, 13009
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Mougins, 06250
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Pessac, 33600
Novo Nordisk Investigational Site
Rennes, 35056
Novo Nordisk Investigational Site
Vénissieux, 69200
Slovakia12 sites
Novo Nordisk Investigational Site
Banská Bystrica, 95717
Novo Nordisk Investigational Site
Bratislava, 811 08
Novo Nordisk Investigational Site
Bratislava, 81526
Novo Nordisk Investigational Site
Bratislava, 82102
Novo Nordisk Investigational Site
Bratislava, 831 01
Novo Nordisk Investigational Site
Košice, 040 01
Novo Nordisk Investigational Site
Košice, 04011
Novo Nordisk Investigational Site
Košice, 04190
Novo Nordisk Investigational Site
Lučenec, 98401
Novo Nordisk Investigational Site
Prešov, 080 01
Novo Nordisk Investigational Site
Šahy, 93601
Novo Nordisk Investigational Site
Žilina, 01001
Denmark8 sites
Novo Nordisk Investigational Site
Aalborg, 9000
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Hellerup, 2900
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
København S, 2300
Novo Nordisk Investigational Site
Køge, 4600
Novo Nordisk Investigational Site
Kolding, 6000
Netherlands7 sites
Novo Nordisk Investigational Site
's-Hertogenbosch, 5223 GV
Novo Nordisk Investigational Site
Amsterdam, 1105 AZ
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Groningen, 9713 GZ
Novo Nordisk Investigational Site
Hengelo, 7555 DL
Novo Nordisk Investigational Site
Sliedrecht, 3361 XV
Novo Nordisk Investigational Site
The Hague, 2512 VA
About this study
Official title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.
This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 14 weeks treatment
Secondary outcomes (3)
Body weight after 14 weeks.
Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154401
- Sponsor's protocol ID
- NN2211-1571
- Status last verified
- Jan 2017
- First submitted
- 8 Sep 2005
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vilsboll T, Brock B, Perrild H, Levin K, Lervang HH, Kolendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14.
PubMed 18201212Courreges JP, Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Buganova I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x. No abstract available.
PubMed 19183322Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courreges JP, Verhoeven R, Buganova I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. doi: 10.2337/dc06-2593. Epub 2007 Mar 19. No abstract available.
PubMed 17372153Horowitz M, Vilsboll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22. No abstract available.
PubMed 18435773Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
PubMed 25504028
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00154401
- Acronym / sponsor ID
- NN2211-1571
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Sep 2005 (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.
This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
- Diet treated subjects: 7.5% < HbA1c < 10%
- Single oral drug therapy subjects: 7.0% < HbA1c < 9.5%
- Body Mass Index (BMI): max 40 kg/m^2
Key exclusion criteria (2 listed)
- Subjects treated with thiazolidinediones or insulin
- Subjects with any serious medical conditions
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 |
|---|---|---|
| liraglutide | Drug | – |
Primary outcome
HbA1c
Time frame: after 14 weeks treatment
3 secondary outcomes
Body weight after 14 weeks.
Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.
Safety and tolerability
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 25 Jan 2017.
- Results publication: PubMed 18201212Vilsboll T, Brock B, Perrild H, Levin K, Lervang HH, Kolendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14.
- Results publication: PubMed 19183322Courreges JP, Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Buganova I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x. No abstract available.
- Results publication: PubMed 17372153Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courreges JP, Verhoeven R, Buganova I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. doi: 10.2337/dc06-2593. Epub 2007 Mar 19. No abstract available.
- Results publication: PubMed 18435773Horowitz M, Vilsboll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22. No abstract available.
- Results publication: PubMed 25504028Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
39 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 39 sites in 4 countries.
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 4 inclusion and 2 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France, Slovakia, Denmark, Netherlands. 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 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.
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: after 14 weeks treatment). 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 NCT00154401, which also lists 5 linked publications.
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 25 Jan 2017.