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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: NPH human insulin; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653341

HOE901/4002

Details and patient eligibility

About

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.

Enrollment: 764 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)