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

January 23, 2017 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • 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
        • Novo Nordisk Investigational Site
  • Norway
      • Bekkestua, Norway, 1357
        • Novo Nordisk Investigational Site
      • Elverum, Norway, 2408
        • Novo Nordisk Investigational Site
      • Harstad, Norway, 9480
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0370
        • Novo Nordisk Investigational Site
  • Sweden
      • 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
        • Novo Nordisk Investigational Site
  • United Kingdom
      • 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
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Once daily injection, under the skin (s.c.) for 12 weeks
Experimental: 0.60 mg
Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Names:
  • NNC 90-1170
Experimental: 0.045 mg
Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Names:
  • NNC 90-1170
Experimental: 0.225 mg
Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Names:
  • NNC 90-1170
Experimental: 0.45 mg
Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Names:
  • NNC 90-1170
Experimental: 0.75 mg
Drug: liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Outcome Measure
Adverse events
Fasting plasma glucose
Fructosamine
7-point blood glucose profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), MD, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

October 1, 2001

Study Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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