Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00653341
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2001-10
• Study Completion: 2001-10
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-17
• Last Update Posted: 2009-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 764

Inclusion Criteria

• Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
• Body mass index between 26 and 40 kg/m2
• HbA1c between 7.5% and 10.0%
• Fasting plasma glucose >7.8 mmol/L and fasting C-peptide > or =0.25 nmol/L

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia

Secondary Outcome Measures

Name	Time	Method
Safety data (Adverse events, vital signs, laboratory values, etc.)

Trial Locations

Locations (1)

Sanofi-aventis administrative office; 🇨🇦 Laval, Canada