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

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355849

  Show 69 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Alkermes, Inc.
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:
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
Insulin, Globin Zinc
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014