Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil) - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00642915

Purpose

To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Lantus, Amaryl	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	A 24 Week, Open-Label, Single Arm, Multi-Center Clinical Study to Document the Benefits of the Combination of Lantus and Amaryl in Ethnic Japanese Type 2 Diabetic Patients Living Outside of Japan (in US or Brazil), Who Failed Good Metabolic Control With Oral Antidiabetic Drugs (OADs)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Glimepiride Insulin glargine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy [ Time Frame: Hemoglobin A1c values were measured at Screening and at every visit thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	June 2003
Study Completion Date:	July 2004

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (NIDDM) (type 2 diabetes) and were not able to maintain good metabolic control with OADs.
Enrolled patients could be male or female, of documented Japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642915

Locations

Brazil
Sanofi-aventis
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Tadaaki Karino

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Publications:

Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008 Jan;79(1):97-102. Epub 2007 Oct 4.

Responsible Party:	Sanofi-Aventis ( Study Director )
Study ID Numbers:	HOE901_4039
Study First Received:	March 19, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00642915 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Glargine
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 09, 2009