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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:
ClinicalTrials.gov Identifier:
NCT01509755
First Posted: January 13, 2012
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: placebo Drug: liraglutide Drug: glimepiride Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures:
  • Fasting plasma glucose
  • Fructosamine
  • 7-point blood glucose profile
  • Adverse events

Estimated Enrollment: 196
Study Start Date: October 2000
Study Completion Date: October 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
Once daily injection, under the skin (s.c.) for 12 weeks
Experimental: 0.045 mg Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Name: NNC 90-1170
Experimental: 0.225 mg Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Name: NNC 90-1170
Experimental: 0.45 mg Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Name: NNC 90-1170
Experimental: 0.60 mg Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Name: NNC 90-1170
Experimental: 0.75 mg Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Name: NNC 90-1170
Active Comparator: Glim Drug: placebo
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509755


Locations
Denmark
Novo Nordisk Investigational Site
Hvidovre, Denmark, 2650
Novo Nordisk Investigational Site
Kolding, Denmark, 6000
Novo Nordisk Investigational Site
København, Denmark, 2400
Novo Nordisk Investigational Site
Køge, Denmark, 4600
Novo Nordisk Investigational Site
Thisted, Denmark, 7700
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Norway
Novo Nordisk Investigational Site
Bekkestua, Norway, 1357
Novo Nordisk Investigational Site
Elverum, Norway, 2408
Novo Nordisk Investigational Site
Harstad, Norway, 9480
Novo Nordisk Investigational Site
Oslo, Norway, 0370
Sweden
Novo Nordisk Investigational Site
Grästorp, Sweden, 467 22
Novo Nordisk Investigational Site
Göteborg, Sweden, 413 45
Novo Nordisk Investigational Site
Lund, Sweden, 221 85
Novo Nordisk Investigational Site
Uppsala, Sweden, 751 85
Novo Nordisk Investigational Site
Örebro, Sweden, 701 85
United Kingdom
Novo Nordisk Investigational Site
Ayrsh, United Kingdom, KA2 0BE
Novo Nordisk Investigational Site
Church Village, United Kingdom, CF38 1AB
Novo Nordisk Investigational Site
Edinburgh, United Kingdom, EH16 4SA
Novo Nordisk Investigational Site
Enfield, United Kingdom, EN2 8JL
Novo Nordisk Investigational Site
Hull, United Kingdom, HU3 2JZ
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE5 4PW
Novo Nordisk Investigational Site
Liverpool, United Kingdom, L7 8XP
Novo Nordisk Investigational Site
Northampton, United Kingdom, NN1 5BD
Novo Nordisk Investigational Site
Nottingham, United Kingdom, NG7 2UH
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX2 6HE
Novo Nordisk Investigational Site
Plymouth, United Kingdom, PL8 8DQ
Novo Nordisk Investigational Site
Rugby, United Kingdom, CV22 5PX
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S5 7AU
Novo Nordisk Investigational Site
Worksop, United Kingdom, S81 OBD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452), MD Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01509755     History of Changes
Other Study ID Numbers: NN2211-1310
First Submitted: January 6, 2012
First Posted: January 13, 2012
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors


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