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

NCT00355849 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2019-09-16

No results posted yet for this study

Summary

A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Human Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 52 weeks

DRUG

Insulin Glargine

patient specific dose, injectable, before meals, 52 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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States
  • Brazil
  • Canada
  • Germany
  • India
  • Israel
  • Puerto Rico
  • Russia
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

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 NCT00355849 on ClinicalTrials.gov