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

NCT ID: NCT00399711

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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repaglinide and metformin combination tablet

Intervention Type DRUG

rosiglitazone and metformin combination tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452), MD

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Vestavia Hills, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Jonesboro, Arkansas, United States

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Chula Vista, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Poway, California, United States

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Redlands, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Mateo, California, United States

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Spring Valley, California, United States

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Colorado Springs, Colorado, United States

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Hamden, Connecticut, United States

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Stamford, Connecticut, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Longwood, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Nampa, Idaho, United States

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Arlington Heights, Illinois, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Flossmoor, Illinois, United States

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Naperville, Illinois, United States

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Oak Brook, Illinois, United States

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Springfield, Illinois, United States

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Vernon Hills, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Shawnee Mission, Kansas, United States

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Topeka, Kansas, United States

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Erlanger, Kentucky, United States

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Louisville, Kentucky, United States

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Bossier City, Louisiana, United States

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Baltimore, Maryland, United States

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Hyattsville, Maryland, United States

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Ann Arbor, Michigan, United States

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Flint, Michigan, United States

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Oak Park, Michigan, United States

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Troy, Michigan, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Jersey City, New Jersey, United States

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Warren Township, New Jersey, United States

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Rochester, New York, United States

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West Seneca, New York, United States

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Asheville, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Franklin, Ohio, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Springfield, Pennsylvania, United States

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Cranston, Rhode Island, United States

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East Providence, Rhode Island, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Simpsonville, South Carolina, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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St. George, Utah, United States

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Henrico, Virginia, United States

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Lebanon, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Milwaukee, Wisconsin, United States

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San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily and three-times-daily dosing of a repaglinide/metformin fixed-dose combination tablet provide similar glycaemic control. Diabetes Obes Metab. 2009 Oct;11(10):947-52. doi: 10.1111/j.1463-1326.2009.01069.x. Epub 2009 Jun 16.

Reference Type RESULT
PMID: 19531054 (View on PubMed)

Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet. Diabetes Obes Metab. 2009 Sep;11(9):865-73. doi: 10.1111/j.1463-1326.2009.01062.x. Epub 2009 May 19.

Reference Type RESULT
PMID: 19476470 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN4440-1794

Identifier Type: -

Identifier Source: org_study_id

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