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CompletedNCT00642915Updated Aug 25, 2008

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

A Phase 4 interventional study of Lantus, Amaryl in Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in Brazil. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-08-25.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

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Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy

    Time frame: 24 weeks

07

Study locations

1 site
  • Sanofi-Aventis
    São Paulo, Brazil
08

References and documents

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. doi: 10.1016/j.diabres.2007.08.007. Epub 2007 Oct 4. PubMed 17919763 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00642915
Lead sponsor
Sanofi
First posted
Mar 25, 2008
Start date
Jun 2003
Completion
Jul 2004
Last update
Aug 25, 2008

Study contacts

Tadaaki Karino
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Insulin Glargine · Glimepiride

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