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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00653341

Run by

Sanofi

People needed

764

Starts

2000-01-01

Expected to finish

2001-10-01

Last updated by the study team

2009-04-20

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Sanofi-aventis administrative office — Bridgewater, New Jersey, United States
• Sanofi-aventis administrative office — Laval, Canada

Full record on ClinicalTrials.gov

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