Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes
NCT ID: NCT01511172
Last Updated: 2017-01-25
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
145 participants
INTERVENTIONAL
2002-08-31
2002-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NNC 90-1170 + Met
liraglutide
Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
metformin
1000 mg daily, administered orally
NNC 90-1170 + Met placebo
placebo
Metformin placebo administered orally. 1000 mg daily
Met + NNC 90-1170 placebo
metformin
1000 mg daily, administered orally
placebo
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
Met + Glim
metformin
1000 mg daily, administered orally
glimepiride
Individually adjusted dose, administered orally
Interventions
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liraglutide
Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
metformin
1000 mg daily, administered orally
placebo
Metformin placebo administered orally. 1000 mg daily
placebo
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
glimepiride
Individually adjusted dose, administered orally
Eligibility Criteria
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Inclusion Criteria
* Duration of type 2 diabetes diagnosis at least one year
* HbA1c 8.0-13.0%, both inclusive
* Body Mass Index (BMI) between 25-40 kg/m\^2, both inclusive.
Exclusion Criteria
* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
* Recurrent major 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 glucose level
* Known or suspected abuse of alcohol or narcotics
* Any contraindications to metformin or glimepiride according to the local guidelines
18 Years
70 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)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Daw Park, South Australia, Australia
Novo Nordisk Investigational Site
Adelaide, , Australia
Novo Nordisk Investigational Site
Ashford, , Australia
Novo Nordisk Investigational Site
Garran, , Australia
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
České Budějovice, , Czechia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Århus C, , Denmark
Novo Nordisk Investigational Site
Copenhagen, , Denmark
Novo Nordisk Investigational Site
Frederiksberg, , Denmark
Novo Nordisk Investigational Site
Køge, , Denmark
Novo Nordisk Investigational Site
Thisted, , Denmark
Novo Nordisk Investigational Site
La Rochelle, , France
Novo Nordisk Investigational Site
Narbonne, , France
Novo Nordisk Investigational Site
Nevers, , France
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Bad Lauterberg im Harz, , Germany
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Bochum, , Germany
Novo Nordisk Investigational Site
Freiburg im Breisgau, , Germany
Novo Nordisk Investigational Site
Kaiserslautern, , Germany
Novo Nordisk Investigational Site
Mannheim, , Germany
Novo Nordisk Investigational Site
Neuss, , Germany
Novo Nordisk Investigational Site
Rawa Mazowiecka, , Poland
Novo Nordisk Investigational Site
Zabrze, , Poland
Novo Nordisk Investigational Site
Addlestone, , United Kingdom
Novo Nordisk Investigational Site
Aylesbury, , United Kingdom
Novo Nordisk Investigational Site
Barnsley, , United Kingdom
Novo Nordisk Investigational Site
Bexhill-on-Sea, , United Kingdom
Novo Nordisk Investigational Site
Caerleon, , United Kingdom
Novo Nordisk Investigational Site
Camberley, , United Kingdom
Novo Nordisk Investigational Site
Chippenham, , United Kingdom
Novo Nordisk Investigational Site
East Horsley, , United Kingdom
Novo Nordisk Investigational Site
Frome, , United Kingdom
Novo Nordisk Investigational Site
Magherafelt, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Novo Nordisk Investigational Site
Soham, , United Kingdom
Novo Nordisk Investigational Site
Sunbury-on-Thames, , United Kingdom
Novo Nordisk Investigational Site
Yaxley. Peterborough, , United Kingdom
Countries
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References
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Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.
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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NN2211-1499
Identifier Type: -
Identifier Source: org_study_id
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