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Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00642915
First received: March 19, 2008
Last updated: August 22, 2008
Last verified: August 2008
History of Changes

March 19, 2008
August 22, 2008
June 2003
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00642915 on ClinicalTrials.gov Archive Site
Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
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)

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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: Lantus, Amaryl
Other Name: insulin glargine,glimepiride
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2004
Not Provided

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.
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00642915
HOE901_4039
Not Provided
Study Director, Sanofi-Aventis
Sanofi
Not Provided
Study Director: Tadaaki Karino Sanofi
Sanofi
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP