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NCT00399711 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00399711
Other study ID # NN4440-1794
Secondary ID
Status Completed
Phase Phase 3
First received November 14, 2006
Last updated February 9, 2017
Start date November 2006
Est. completion date November 2007

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 560
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide and metformin combination tablet

• rosiglitazone and metformin combination tablet

Locations
Country Name City State
Puerto Rico Novo Nordisk Investigational Site San Juan
United States Novo Nordisk Investigational Site Ann Arbor Michigan
United States Novo Nordisk Investigational Site Arlington Heights Illinois
United States Novo Nordisk Investigational Site Asheville North Carolina
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Aurora Illinois
United States Novo Nordisk Investigational Site Aventura Florida
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Berlin New Jersey
United States Novo Nordisk Investigational Site Bossier City Louisiana
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chula Vista California
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Clearwater Florida
United States Novo Nordisk Investigational Site Colorado Springs Colorado
United States Novo Nordisk Investigational Site Columbus Georgia
United States Novo Nordisk Investigational Site Corpus Christi Texas
United States Novo Nordisk Investigational Site Cranston Rhode Island
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Daytona Beach Florida
United States Novo Nordisk Investigational Site Des Moines Iowa
United States Novo Nordisk Investigational Site East Providence Rhode Island
United States Novo Nordisk Investigational Site Erlanger Kentucky
United States Novo Nordisk Investigational Site Flint Michigan
United States Novo Nordisk Investigational Site Flossmoor Illinois
United States Novo Nordisk Investigational Site Franklin Ohio
United States Novo Nordisk Investigational Site Glendale Arizona
United States Novo Nordisk Investigational Site Greenville North Carolina
United States Novo Nordisk Investigational Site Greer South Carolina
United States Novo Nordisk Investigational Site Hamden Connecticut
United States Novo Nordisk Investigational Site Henrico Virginia
United States Novo Nordisk Investigational Site Honolulu Hawaii
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Hyattsville Maryland
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Inverness Florida
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Jersey City New Jersey
United States Novo Nordisk Investigational Site Jonesboro Arkansas
United States Novo Nordisk Investigational Site Kansas City Missouri
United States Novo Nordisk Investigational Site Kingsport Tennessee
United States Novo Nordisk Investigational Site Knoxville Tennessee
United States Novo Nordisk Investigational Site Las Vegas Nevada
United States Novo Nordisk Investigational Site Las Vegas Nevada
United States Novo Nordisk Investigational Site Lebanon Virginia
United States Novo Nordisk Investigational Site Long Beach California
United States Novo Nordisk Investigational Site Longwood Florida
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Louisville Kentucky
United States Novo Nordisk Investigational Site Marietta Georgia
United States Novo Nordisk Investigational Site Mesa Arizona
United States Novo Nordisk Investigational Site Midland Texas
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site Mt. Pleasant South Carolina
United States Novo Nordisk Investigational Site Nampa Idaho
United States Novo Nordisk Investigational Site Naperville Illinois
United States Novo Nordisk Investigational Site Norristown Pennsylvania
United States Novo Nordisk Investigational Site Oak Brook Illinois
United States Novo Nordisk Investigational Site Oak Park Michigan
United States Novo Nordisk Investigational Site Ocala Florida
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Orlando Florida
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Plano Texas
United States Novo Nordisk Investigational Site Plantation Florida
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Poway California
United States Novo Nordisk Investigational Site Raleigh North Carolina
United States Novo Nordisk Investigational Site Redlands California
United States Novo Nordisk Investigational Site Richmond Virginia
United States Novo Nordisk Investigational Site Rochester New York
United States Novo Nordisk Investigational Site Sacramento California
United States Novo Nordisk Investigational Site Salisbury North Carolina
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site San Mateo California
United States Novo Nordisk Investigational Site Shawnee Mission Kansas
United States Novo Nordisk Investigational Site Simpsonville South Carolina
United States Novo Nordisk Investigational Site Spring Valley California
United States Novo Nordisk Investigational Site Springfield Illinois
United States Novo Nordisk Investigational Site Springfield Pennsylvania
United States Novo Nordisk Investigational Site St. George Utah
United States Novo Nordisk Investigational Site Stamford Connecticut
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Topeka Kansas
United States Novo Nordisk Investigational Site Troy Michigan
United States Novo Nordisk Investigational Site Tulsa Oklahoma
United States Novo Nordisk Investigational Site Tulsa Oklahoma
United States Novo Nordisk Investigational Site Vernon Hills Illinois
United States Novo Nordisk Investigational Site Vestavia Alabama
United States Novo Nordisk Investigational Site Virginia Beach Virginia
United States Novo Nordisk Investigational Site Warren New Jersey
United States Novo Nordisk Investigational Site West Palm Beach Florida
United States Novo Nordisk Investigational Site West Seneca New York
United States Novo Nordisk Investigational Site Wilmington North Carolina
United States Novo Nordisk Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

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. — View Citation

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. Diabe — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c After 26 weeks of treatment
Secondary Change in 8-point Glucose Profiles
Secondary Change in Lipid Profile
Secondary Events of hypoglycemia
Secondary Safety parameters
Secondary Change in Fasting Plasma Glucose
Secondary Waist/hip ratio change
Secondary Change in body weight
Secondary Percentage of subjects achieving sudden levels of HbA1c
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