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Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

NCT00356109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2018-03-09

No results posted yet for this study

Summary

A study to test for non-inferiority of preprandial HIIP \[also known as AIR® Inhaled Insulin Powder\]\[AIR® is a registered trademark of Alkermes,Inc.\] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.

This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.

The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Human Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 6 months

DRUG

Injectable insulin

patient specific dose, injected, before meals, 6 months

DRUG

Insulin Glargine

patient specific dose, injectable, before meals, 6 months

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
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Argentina
  • Belgium
  • France
  • Germany
  • India
  • Italy
  • Mexico
  • Puerto Rico

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 NCT00356109 on ClinicalTrials.gov