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

• Status: Completed
• Trial end date: 2001-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

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