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

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00355849
First received: July 21, 2006
Last updated: October 13, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Human Insulin Inhalation Powder
Drug: Insulin Glargine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure changes in HbA1c over time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess insulin dose requirements [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]
  • To assess rate and incidence of hypoglycemia [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 555
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intensified Glargine
 Drug: Insulin Glargine
patient specific dose, injectable, before meals, 52 weeks
Experimental: 2
HIIP
 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 52 weeks
Other Name: LY041001
Experimental: 3
Intensified Glargine plus HIIP
 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 52 weeks
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, before meals, 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus
  • one or more oral antihyperglycemic medications
  • once-daily insulin glargine
  • HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
  • Non-smoker

Exclusion Criteria:

  • taking a TZD dose greater than what is indicated
  • more than two episodes of severe hypoglycemia during the 6 months prior
  • Have had a lower respiratory infection in the 3 months prior
  • systemic glucocorticoid therapy
  • clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • history of renal transplantation
  • Have an active or untreated malignancy
  • Require more than 150 U/day of insulin glargine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355849

  Show 69 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Alkermes
Investigators
Study Director: 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
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00355849     History of Changes
Other Study ID Numbers: 9632, H7U-MC-IDBA
Study First Received: July 21, 2006
Last Updated: October 13, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013