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Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)

NCT00979628 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2018-10-10

Study results available
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Summary

The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.

Conditions

Interventions

DRUG

sliding scale regular insulin (SSRI)

four-time daily in patients with T2DM admitted to general medicine and surgery wards.

DRUG

Basal Bolus

glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)

DRUG

Basal Plus

glargine once daily plus corrective doses of glulisine before meals and bedtime as needed

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Medical University of South Carolina

    collaborator OTHER

  • Texas A&M University

    collaborator OTHER

  • Guillermo Umpierrez, MD

    lead OTHER

Principal Investigators

  • Guillermo Umpierrez, MD · Emory SOM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00979628 on ClinicalTrials.gov