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 A/S
ClinicalTrials.gov Identifier:
NCT01509755
First received: January 6, 2012
Last updated: January 12, 2012
Last verified: January 2012
  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: NNC 90-1170
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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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: NNC 90-1170
Once daily injection, under the skin (s.c.) for 12 weeks
Experimental: 0.225 mg Drug: NNC 90-1170
Once daily injection, under the skin (s.c.) for 12 weeks
Experimental: 0.45 mg Drug: NNC 90-1170
Once daily injection, under the skin (s.c.) for 12 weeks
Experimental: 0.60 mg Drug: NNC 90-1170
Once daily injection, under the skin (s.c.) for 12 weeks
Experimental: 0.75 mg Drug: NNC 90-1170
Once daily injection, under the skin (s.c.) for 12 weeks
Active Comparator: Glim Drug: glimepiride
Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509755

Locations
Denmark
Hvidovre, Denmark, 2650
Norway
Harstad, Norway, 9480
Sweden
Uppsala, Sweden, 751 85
United Kingdom
Leicester, United Kingdom, LE5 4PW
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Peter Damsbo, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01509755     History of Changes
Other Study ID Numbers: NN2211-1310
Study First Received: January 6, 2012
Last Updated: January 12, 2012
Health Authority: Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014