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Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01509755
First received: January 6, 2012
Last updated: January 12, 2012
Last verified: January 2012
History of Changes

January 6, 2012
January 12, 2012
October 2000
October 2001   (final data collection date for primary outcome measure)
HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01509755 on ClinicalTrials.gov Archive Site
  • Fasting plasma glucose [ Designated as safety issue: No ]
  • Fructosamine [ Designated as safety issue: No ]
  • 7-point blood glucose profile [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes
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.
Not Provided
Interventional
Phase 2
Not Provided
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: placebo
    Once daily injection, under the skin (s.c.) for 12 weeks
  • Drug: NNC 90-1170
    Once daily injection, under the skin (s.c.) for 12 weeks
  • Drug: glimepiride
    Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: 0.045 mg
    Intervention: Drug: NNC 90-1170
  • Experimental: 0.225 mg
    Intervention: Drug: NNC 90-1170
  • Experimental: 0.45 mg
    Intervention: Drug: NNC 90-1170
  • Experimental: 0.60 mg
    Intervention: Drug: NNC 90-1170
  • Experimental: 0.75 mg
    Intervention: Drug: NNC 90-1170
  • Active Comparator: Glim
    Intervention: Drug: glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
October 2001
October 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Norway,   Sweden,   United Kingdom
 
NCT01509755
NN2211-1310
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Peter Damsbo, MD Novo Nordisk
Novo Nordisk
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP