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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653341

Enrollment

764

Registered

2008-04-04

Start date

2000-01-31

Completion date

2001-10-31

Last updated

2009-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

insulin naive

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.

Interventions

DRUGinsulin glargine

DRUGNPH human insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety data (Adverse events, vital signs, laboratory values, etc.)	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026