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

Sanofi764 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

764

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glargineDRUG

NPH human insulinDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Sanofi-aventis administrative office

Bridgewater, New Jersey, United States

Sanofi-aventis administrative office

Laval, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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