Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes
NCT ID: NCT01509755
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2000-10-31
2001-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Placebo
placebo
Once daily injection, under the skin (s.c.) for 12 weeks
0.045 mg
liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
0.225 mg
liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
0.45 mg
liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
0.60 mg
liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
0.75 mg
liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Glim
placebo
Once daily injection, under the skin (s.c.) for 12 weeks
glimepiride
Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response
Interventions
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placebo
Once daily injection, under the skin (s.c.) for 12 weeks
liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
glimepiride
Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452), MD
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Århus C, , Denmark
Novo Nordisk Investigational Site
Copenhagen, , Denmark
Novo Nordisk Investigational Site
Hvidovre, , Denmark
Novo Nordisk Investigational Site
Kolding, , Denmark
Novo Nordisk Investigational Site
Køge, , Denmark
Novo Nordisk Investigational Site
Thisted, , Denmark
Novo Nordisk Investigational Site
Bekkestua, , Norway
Novo Nordisk Investigational Site
Elverum, , Norway
Novo Nordisk Investigational Site
Harstad, , Norway
Novo Nordisk Investigational Site
Oslo, , Norway
Novo Nordisk Investigational Site
Gothenburg, , Sweden
Novo Nordisk Investigational Site
Grästorp, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Örebro, , Sweden
Novo Nordisk Investigational Site
Uppsala, , Sweden
Novo Nordisk Investigational Site
Ayrsh, , United Kingdom
Novo Nordisk Investigational Site
Church Village, , United Kingdom
Novo Nordisk Investigational Site
Edinburgh, , United Kingdom
Novo Nordisk Investigational Site
Enfield, , United Kingdom
Novo Nordisk Investigational Site
Hull, , United Kingdom
Novo Nordisk Investigational Site
Leicester, , United Kingdom
Novo Nordisk Investigational Site
Liverpool, , United Kingdom
Novo Nordisk Investigational Site
Northampton, , United Kingdom
Novo Nordisk Investigational Site
Nottingham, , United Kingdom
Novo Nordisk Investigational Site
Oxford, , United Kingdom
Novo Nordisk Investigational Site
Plymouth, , United Kingdom
Novo Nordisk Investigational Site
Rugby, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Novo Nordisk Investigational Site
Worksop, , United Kingdom
Countries
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References
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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.
Jensen 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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-1310
Identifier Type: -
Identifier Source: org_study_id
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