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

Sanofi100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Diabetes Mellitus

Interventions

Lantus, AmarylDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

São Paulo, Brazil

Outcomes

Primary Outcomes

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

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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