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Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes

NCT00437112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-03-09

No results posted yet for this study

Summary

A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Human Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 24 weeks

DRUG

Insulin Glargine

patient specific dose, injectable, before meals, 24 weeks

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Brazil
  • India
  • Puerto Rico
  • Spain

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 NCT00437112 on ClinicalTrials.gov