Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

February 9, 2017 updated by: Novo Nordisk A/S

Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety

This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

560

Phase

  • Phase 3

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

  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Vestavia, Alabama, United States, 35209
        • Novo Nordisk Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Novo Nordisk Investigational Site
      • Mesa, Arizona, United States, 85206
        • Novo Nordisk Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Novo Nordisk Investigational Site
    • California
      • Chula Vista, California, United States, 91911
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90807
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • Redlands, California, United States, 92374
        • Novo Nordisk Investigational Site
      • Sacramento, California, United States, 95825
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92121
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92128
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Novo Nordisk Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Novo Nordisk Investigational Site
      • Stamford, Connecticut, United States, 06905
        • Novo Nordisk Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33765
        • Novo Nordisk Investigational Site
      • Daytona Beach, Florida, United States, 32117
        • Novo Nordisk Investigational Site
      • Inverness, Florida, United States, 34452
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32259
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32116
        • Novo Nordisk Investigational Site
      • Longwood, Florida, United States, 32779
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32804
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Columbus, Georgia, United States, 31904
        • Novo Nordisk Investigational Site
      • Marietta, Georgia, United States, 30066
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Idaho
      • Nampa, Idaho, United States, 83687
        • Novo Nordisk Investigational Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Novo Nordisk Investigational Site
      • Aurora, Illinois, United States, 60504
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60616
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60611
        • Novo Nordisk Investigational Site
      • Flossmoor, Illinois, United States, 60422
        • Novo Nordisk Investigational Site
      • Naperville, Illinois, United States, 60564
        • Novo Nordisk Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
      • Vernon Hills, Illinois, United States, 60061
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Novo Nordisk Investigational Site
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Erlanger, Kentucky, United States, 41018
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Novo Nordisk Investigational Site
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Novo Nordisk Investigational Site
      • Flint, Michigan, United States, 48504
        • Novo Nordisk Investigational Site
      • Oak Park, Michigan, United States, 48237
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89123
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Jersey City, New Jersey, United States, 07306
        • Novo Nordisk Investigational Site
      • Warren, New Jersey, United States, 07059
        • Novo Nordisk Investigational Site
    • New York
      • Rochester, New York, United States, 14609
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Novo Nordisk Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Novo Nordisk Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Novo Nordisk Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97220
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19152
        • Novo Nordisk Investigational Site
      • Springfield, Pennsylvania, United States, 19064-2527
        • Novo Nordisk Investigational Site
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Novo Nordisk Investigational Site
      • East Providence, Rhode Island, United States, 02914
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Novo Nordisk Investigational Site
      • Simpsonville, South Carolina, United States, 29681-1538
        • Novo Nordisk Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Novo Nordisk Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75224
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77024
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75093
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Utah
      • St. George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
    • Virginia
      • Henrico, Virginia, United States, 23233
        • Novo Nordisk Investigational Site
      • Lebanon, Virginia, United States, 24266
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23229
        • Novo Nordisk Investigational Site
      • Virginia Beach, Virginia, United States, 23454
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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:

  • Type 2 diabetes for at least 3 months
  • HbA1c between 7.5-11.0% on monotherapy or
  • HbA1c between 7.0-10.0% on dual therapy
  • BMI maximum 45 kg/m2

Exclusion Criteria:

  • Any clinically significant disease history in the opinion of the investigator
  • Severe heart disease
  • Pregnancy

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: After 26 weeks of treatment
After 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Change in body weight
Safety parameters
Change in 8-point Glucose Profiles
Change in Lipid Profile
Events of hypoglycemia
Change in Fasting Plasma Glucose
Waist/hip ratio change
Percentage of subjects achieving sudden levels of HbA1c

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

November 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (Estimate)

November 15, 2006

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN4440-1794

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on repaglinide and metformin combination tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe