Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

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

Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

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

  • Australia
      • Adelaide, Australia, SA 5035
        • Novo Nordisk Investigational Site
      • Ashford, Australia, 5035
        • Novo Nordisk Investigational Site
      • Garran, Australia, 2605
        • Novo Nordisk Investigational Site
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Novo Nordisk Investigational Site
  • Austria
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
      • Wien, Austria, A 1090
        • Novo Nordisk Investigational Site
      • Wien, Austria, A-1130
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Ceske Budejovice, Czech Republic, 37001
        • Novo Nordisk Investigational Site
      • Praha 10, Czech Republic, 10034
        • Novo Nordisk Investigational Site
  • Denmark
      • Frederiksberg, Denmark, 2000
        • 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
  • France
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Paris Cedex 10, France, 75475
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Lauterberg, Germany, 37431
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 12203
        • Novo Nordisk Investigational Site
      • Bochum, Germany, 44791
        • Novo Nordisk Investigational Site
      • Freiburg, Germany, 79106
        • Novo Nordisk Investigational Site
      • Kaiserslautern, Germany, 67675
        • Novo Nordisk Investigational Site
      • Mannheim, Germany, 68167
        • Novo Nordisk Investigational Site
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site
  • Poland
      • Rawa Mazowiecka, Poland, 96-200
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Addlestone, United Kingdom, KT15 2BH
        • Novo Nordisk Investigational Site
      • Aylesbury, United Kingdom, HP21 7TL
        • Novo Nordisk Investigational Site
      • Barnsley, United Kingdom, S70 3RJ
        • Novo Nordisk Investigational Site
      • Bexhill-on-Sea, United Kingdom, TN39 4SP
        • Novo Nordisk Investigational Site
      • Caerleon, United Kingdom, NP18 1AZ
        • Novo Nordisk Investigational Site
      • Camberley, United Kingdom, GU15 2NN
        • Novo Nordisk Investigational Site
      • Chippenham, United Kingdom, SN15 1HP
        • Novo Nordisk Investigational Site
      • East Horsley, United Kingdom, KT24 6QT
        • Novo Nordisk Investigational Site
      • Frome, United Kingdom, BA11 1EZ
        • Novo Nordisk Investigational Site
      • Magherafelt, United Kingdom
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S3 9DA
        • Novo Nordisk Investigational Site
      • Soham, United Kingdom, CB7 5JD
        • Novo Nordisk Investigational Site
      • Sunbury on Thames, United Kingdom, TW16 6RH
        • Novo Nordisk Investigational Site
      • Yaxley. Peterborough, United Kingdom, PE7 3JL
        • 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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
  • Duration of type 2 diabetes diagnosis at least one year
  • HbA1c 8.0-13.0%, both inclusive
  • Body Mass Index (BMI) between 25-40 kg/m^2, both inclusive.

Exclusion Criteria:

  • Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
  • Impaired liver function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
  • Recurrent major 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 glucose level
  • Known or suspected abuse of alcohol or narcotics
  • Any contraindications to metformin or glimepiride according to the local guidelines

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NNC 90-1170 + Met
Drug: liraglutide
Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
Drug: metformin
1000 mg daily, administered orally
EXPERIMENTAL: NNC 90-1170 + Met placebo
Drug: placebo
Metformin placebo administered orally. 1000 mg daily
Drug: placebo
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
PLACEBO_COMPARATOR: Met + NNC 90-1170 placebo
Drug: metformin
1000 mg daily, administered orally
Drug: placebo
Metformin placebo administered orally. 1000 mg daily
Drug: placebo
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
ACTIVE_COMPARATOR: Met + Glim
Drug: metformin
1000 mg daily, administered orally
Drug: glimepiride
Individually adjusted dose, administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting plasma/serum glucose

Secondary Outcome Measures

Outcome Measure
C-peptide
Weight
Insulin
Other adverse events
Home monitored fasting plasma glucose
Home monitored 7-point glucose profile
Fructosamine
HbA1c (glycated haemoglobin A1c)
Beta-cell function and insulin resistance (HOMA model)
Gastro-intestinal adverse events

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

August 1, 2002

Primary Completion (ACTUAL)

December 1, 2002

Study Completion (ACTUAL)

December 1, 2002

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (ESTIMATE)

January 18, 2012

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

  • NN2211-1499

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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