Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

January 24, 2017 updated by: Novo Nordisk A/S

Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.

This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

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
      • Aalborg, Denmark, 9000
        • Novo Nordisk Investigational Site
      • Hellerup, Denmark, 2900
        • 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
      • København S, Denmark, 2300
        • Novo Nordisk Investigational Site
      • Køge, Denmark, 4600
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • France
      • Antibes, France, 06600
        • Novo Nordisk Investigational Site
      • DAX, France, 40107
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Marseille, France, 13009
        • Novo Nordisk Investigational Site
      • Montpellier, France, 34295
        • Novo Nordisk Investigational Site
      • Mougins, France, 06250
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Nimes, France, 30006
        • Novo Nordisk Investigational Site
      • Pessac, France, 33600
        • Novo Nordisk Investigational Site
      • Rennes, France, 35056
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Novo Nordisk Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Den Bosch, Netherlands, 5223 GV
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2512 VA
        • Novo Nordisk Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • Novo Nordisk Investigational Site
      • Hengelo, Netherlands, 7555 DL
        • Novo Nordisk Investigational Site
      • Sliedrecht, Netherlands, 3361 XV
        • Novo Nordisk Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia, 95717
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 831 01
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 811 08
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 82102
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 81526
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 040 01
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 04011
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 04190
        • Novo Nordisk Investigational Site
      • Lucenec, Slovakia, 98401
        • Novo Nordisk Investigational Site
      • Presov, Slovakia, 080 01
        • Novo Nordisk Investigational Site
      • Sahy, Slovakia, 93601
        • Novo Nordisk Investigational Site
      • Zilina, Slovakia, 01001
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
  • Diet treated subjects: 7.5% < HbA1c < 10%
  • Single oral drug therapy subjects: 7.0% < HbA1c < 9.5%
  • Body Mass Index (BMI): max 40 kg/m^2

Exclusion Criteria:

  • Subjects treated with thiazolidinediones or insulin
  • Subjects with any serious medical conditions

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 14 weeks treatment
after 14 weeks treatment

Secondary Outcome Measures

Outcome Measure
Safety and tolerability
Body weight after 14 weeks.
Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.

Collaborators and Investigators

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

Sponsor

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

January 1, 2005

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1571

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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