DiabetesPhase 2NCT01509755
Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes
A Phase 2 study testing liraglutide and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 29 sites in 4 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide and glimepiride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 29 sitesin 4 countries
- Study dates
- Oct 2000to Oct 2001
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes
- Duration of diabetes at least 3 months
- Both diet treated and patients in therapy with OHA (oral hypoglycemic agents)
- Body Mass Index maximum 40 kg/m^2
- HbA1c based on analysis from central laboratory: Between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for OHA treated
Who cannot join
- Liver or renal disease
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Proliferative retinopathy
- Recurrent severe hypoglycaemia as judged by the Investigator
- Known or suspected allergy to trial product or related products
- Use of any drug (except for OHAs) which in the Investigator's opinion could interfere with the blood glucose level
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
United Kingdom14 sites
Novo Nordisk Investigational Site
Ayrsh, KA2 0BE
Novo Nordisk Investigational Site
Church Village, CF38 1AB
Novo Nordisk Investigational Site
Edinburgh, EH16 4SA
Novo Nordisk Investigational Site
Enfield, EN2 8JL
Novo Nordisk Investigational Site
Hull, HU3 2JZ
Novo Nordisk Investigational Site
Leicester, LE5 4PW
Novo Nordisk Investigational Site
Liverpool, L7 8XP
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Oxford, OX2 6HE
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
Rugby, CV22 5PX
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Worksop, S81 OBD
Denmark6 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
Køge, 4600
Novo Nordisk Investigational Site
Kolding, 6000
Novo Nordisk Investigational Site
Thisted, 7700
Sweden5 sites
Novo Nordisk Investigational Site
Gothenburg, 413 45
Novo Nordisk Investigational Site
Grästorp, 467 22
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Uppsala, 751 85
Norway4 sites
Novo Nordisk Investigational Site
Bekkestua, 1357
Novo Nordisk Investigational Site
Elverum, 2408
Novo Nordisk Investigational Site
Harstad, 9480
Novo Nordisk Investigational Site
Oslo, 0370
About this study
Official title: Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm
This trial is conducted in Europe. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- placebo, liraglutide, glimepiride
- 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.
placeboDrug
Once daily injection, under the skin (s.c.) for 12 weeks
liraglutideDrug
Also called NNC 90-1170
Once daily injection, under the skin (s.c.) for 12 weeks
glimepirideDrug
Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
| 0.045 mg | Experimental | Not described Receives: Drug: liraglutide |
| 0.225 mg | Experimental | Not described Receives: Drug: liraglutide |
| 0.45 mg | Experimental | Not described Receives: Drug: liraglutide |
| 0.60 mg | Experimental | Not described Receives: Drug: liraglutide |
| 0.75 mg | Experimental | Not described Receives: Drug: liraglutide |
| Glim | Active comparator | Not described Receives: Drug: placebo; Drug: glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin)
Secondary outcomes (4)
Fasting plasma glucose
Fructosamine
7-point blood glucose profile
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startOct 2000
- Primary completionOct 2001
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), MD, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509755
- Sponsor's protocol ID
- NN2211-1310
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2012
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR; NN2211-1310 International Study Group. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care. 2004 Jun;27(6):1335-42. doi: 10.2337/diacare.27.6.1335.
PubMed 15161785Jensen 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 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm
- ClinicalTrials.gov ID
- NCT01509755
- Acronym / sponsor ID
- NN2211-1310
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Oct 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 13 Jan 2012 (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 aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.
Study design
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo |
| 0.045 mg | Experimental | Drug: liraglutide |
| 0.225 mg | Experimental | Drug: liraglutide |
| 0.45 mg | Experimental | Drug: liraglutide |
| 0.60 mg | Experimental | Drug: liraglutide |
| 0.75 mg | Experimental | Drug: liraglutide |
| Glim | Active comparator | Drug: placebo, Drug: glimepiride |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with type 2 diabetes
- Duration of diabetes at least 3 months
- Both diet treated and patients in therapy with OHA (oral hypoglycemic agents)
- Body Mass Index maximum 40 kg/m^2
- HbA1c based on analysis from central laboratory: Between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for OHA treated
Key exclusion criteria (7 listed)
- Liver or renal disease
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Proliferative retinopathy
- Recurrent severe hypoglycaemia as judged by the Investigator
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 |
|---|---|---|
| placeboOnce daily injection, under the skin (s.c.) for 12 weeks | Drug | Glim, Placebo |
| liraglutideAlso: NNC 90-1170Once daily injection, under the skin (s.c.) for 12 weeks | Drug | 0.045 mg, 0.225 mg, 0.45 mg, 0.60 mg, 0.75 mg |
| glimepirideTablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response | Drug | Glim |
Primary outcome
HbA1c (glycosylated haemoglobin)
4 secondary outcomes
Fasting plasma glucose
Fructosamine
7-point blood glucose profile
Adverse events
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 24 Jan 2017.
- Results publication: PubMed 15161785Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR; NN2211-1310 International Study Group. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care. 2004 Jun;27(6):1335-42. doi: 10.2337/diacare.27.6.1335.
- 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), MD study director
Novo Nordisk A/S
29 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 and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 29 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 5 inclusion and 7 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 24 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 29 sites in United Kingdom, Denmark, Sweden, Norway. 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 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 (glycosylated haemoglobin). 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 NCT01509755, which also lists 2 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 24 Jan 2017.