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 - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00399711

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: repaglinide and metformin combination tablet Drug: rosiglitazone and metformin combination tablet	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Twice Daily Versus Thrice Daily Repaglinide and Metformin Combination Tablet and Rosiglitazone and Metformin in Fixed Dose Combination on HbA1c in Subjects With Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Rosiglitazone Repaglinide Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in 8-point Glucose Profiles [ Designated as safety issue: No ]
Change in Lipid Profile [ Designated as safety issue: No ]
Events of hypoglycemia [ Designated as safety issue: No ]
Safety parameters [ Designated as safety issue: No ]
Change in Fasting Plasma Glucose [ Designated as safety issue: No ]
Waist/hip ratio change [ Designated as safety issue: No ]
Change in body weight [ Designated as safety issue: No ]
Percentage of subjects achieving sudden levels of HbA1c [ Designated as safety issue: No ]

Enrollment:	560
Study Start Date:	November 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399711

Show 53 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Campbell Howard, MD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00399711 History of Changes
Other Study ID Numbers:	NN4440-1794
Study First Received:	November 14, 2006
Last Updated:	September 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide

Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012