Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)

NCT00377858 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2009-12-09

Study results available
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Summary

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin lispro mid mixture (MM)

Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks

DRUG

Insulin glargine

Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Australia
  • Canada
  • France
  • Mexico
  • Russia
  • South Korea
  • Spain

Study Locations

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Entities

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 NCT00377858 on ClinicalTrials.gov