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Insulin Glargine at Bedtime or in AM Versus NPH

NCT00686712 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-05-22

Study results available
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Summary

To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.

Conditions

Interventions

DRUG

1- Insulin glargine QHS

Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL)

DRUG

2 - Insulin glargine QAM

Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL)

DRUG

3 - NPH insulin QHS

NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Charles Drew University of Medicine and Science

    lead OTHER

Principal Investigators

  • Stanley Hsia, MD · Charles Drew University of Medicine and Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00686712 on ClinicalTrials.gov