Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.

Sanofi1 site in 1 country764 target enrollmentJanuary 2000

ConditionsDiabetes Mellitus, Type 2

Drugsinsulin glargine NPH human insulin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Enrollment: 764
Locations: 1
Primary Endpoint: Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2000

End Date

October 2001

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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