Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

January 25, 2017 updated by: Novo Nordisk A/S

NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

223

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

  • United States
    • Alabama
      • Vestavia, Alabama, United States, 35209
        • Novo Nordisk Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Novo Nordisk Investigational Site
    • Arkansas
      • Carlisle, Arkansas, United States, 72024
        • Novo Nordisk Investigational Site
      • Jonesboro, Arkansas, United States, 72401
        • Novo Nordisk Investigational Site
    • California
      • Alhambra, California, United States, 91801
        • Novo Nordisk Investigational Site
      • Mission Viejo, California, United States, 92691
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Novo Nordisk Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • St. Petersburg, Florida, United States, 33702
        • Novo Nordisk Investigational Site
      • Titusville, Florida, United States, 32796
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Novo Nordisk Investigational Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63117
        • Novo Nordisk Investigational Site
    • New Jersey
      • North Plainfield, New Jersey, United States, 07060
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • Durham, North Carolina, United States, 27710
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78209
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Novo Nordisk Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Novo Nordisk Investigational Site
    • Washington
      • Edmonds, Washington, United States, 98026-7610
        • Novo Nordisk Investigational Site
      • Edmonds, Washington, United States, 98026
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Tacoma, Washington, United States, 98405
        • Novo Nordisk Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetic
  • Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
  • Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)
  • HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Proliferative retinopathy or known autonomic neuropathy
  • Recurrent severe hypoglycemia 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 investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
  • Known or suspected abuse of alcohol or narcotics
  • Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
  • TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
  • Type 1 or other specific causes of diabetes

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.60 mg
Drug: liraglutide
Injected subcutaneously once daily
Other Names:
  • NNC 90-1170
Active Comparator: Met
Drug: metformin
1000 mg twice daily, administered orally
Experimental: 0.045 mg
Drug: liraglutide
Injected subcutaneously once daily
Other Names:
  • NNC 90-1170
Experimental: 0.225 mg
Drug: liraglutide
Injected subcutaneously once daily
Other Names:
  • NNC 90-1170
Experimental: 0.45 mg
Drug: liraglutide
Injected subcutaneously once daily
Other Names:
  • NNC 90-1170
Experimental: 0.75 mg
Drug: liraglutide
Injected subcutaneously once daily
Other Names:
  • NNC 90-1170

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Body weight

Secondary Outcome Measures

Outcome Measure
Adverse events
HbA1c (glycosylated haemoglobin)
FPG (fasting plasma glucose)
Fructosamine
Lipids

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

February 1, 2001

Primary Completion (Actual)

October 1, 2001

Study Completion (Actual)

October 1, 2001

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 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-2072

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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