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Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

NCT00135096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2011-01-11

No results posted yet for this study

Summary

The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

insulin glulisine

PREMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day 0-15 min before the three main meals; metformin (if applicable); and Lantus qd for 52 weeks.

DRUG

insulin glargine

POSTMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day immediately after a meal (20 min after the start of a meal); metformin (if applicable); and Lantus qd for 52 weeks.

Sponsors & Collaborators

Principal Investigators

  • Karen Barch, B.S. · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-08-31
Completion
2007-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00135096 on ClinicalTrials.gov