Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on OAD

This study has been completed.

First Received: June 25, 2007 Last Updated: April 30, 2009 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00491725

Purpose

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetes drugs).

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: repaglinide Drug: metformin	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: AG-EE 388 ZW Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Chinese Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post Prandial Plasma Glucose [ Designated as safety issue: No ]
Fasting Plasma Glucose (FPG) [ Designated as safety issue: No ]
Safety profile [ Designated as safety issue: No ]

Enrollment:	187
Study Start Date:	September 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes for at least 12 weeks
HbA1c: 8.0-10.0%
Current treatment with OAD on monotheray or OAD on combination therapy
Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion Criteria:

Known or suspected allergy to trial product(s) or related products
Recurrent major hypoglycaemia as judged by the Investigator
Uncontrolled hypertension
Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491725

Locations

China

Beijing, China, 100029

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

JIN Pingping, Bsc

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	AGEE-1655
Study First Received:	June 25, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00491725 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Repaglinide

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Repaglinide

ClinicalTrials.gov processed this record on May 07, 2009