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Insulin Glulisine in Type 2 Diabetic Patients

NCT00360698 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2011-08-08

Study results available
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Summary

To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

One daily injection at bedtime

DRUG

Glimepiride

At same dosage as during the run-in period

DRUG

Insulin Glulisine

One bolus given before the main meal

DRUG

Metformin

At same dosage as during the run-in period

Sponsors & Collaborators

Principal Investigators

  • PILORGET Valérie, MD · Sanofi

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
2006-07-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Russia
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT00360698 on ClinicalTrials.gov