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

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00437112
First received: February 16, 2007
Last updated: July 15, 2008
Last verified: July 2008
  Purpose

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.


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: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in HbA1c from baseline to various timepoints [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Insulin dose requirements [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Patient-reported outcomes of W-BQ12 [ Time Frame: screening,baseline, week 12,24, and 48 ] [ Designated as safety issue: No ]
  • Hypoglycemia rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Changes in body weight [ Time Frame: every visit ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Safety as assessed by total pulmonary function testing and fasting lipid profile [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Assess inhaler reliability. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Patient Reported outcomes of DSC-R [ Time Frame: screening,baseline, week 12,24, and 48 ] [ Designated as safety issue: No ]
  • Patient reported outcomes of DTSQS [ Time Frame: screening,baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Patient reported outcome of IDSQ [ Time Frame: week 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Patient reported outcome of preference questionnaire [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Patient reported outcome of Expectations About Insulin Therapy Questionnaire [ Time Frame: screening,baseline ] [ Designated as safety issue: No ]
  • Patient reported outcome of Experience with Insulin Therapy Questionnaire [ Time Frame: week 12, 24 and 48 ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

4 week pretreatment phase consists of continuation of usual OAM therapy

24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation

8 week follow up period

Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 weeks
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, before meals, 24 weeks
Experimental: 2

4 week pretreatment phase consists of continuation of usual OAM therapy

24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation

8 week follow up period

Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 weeks
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, before meals, 24 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
  • Insulin naive
  • One or more oral antihyperglycemic medications
  • HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
  • Non-smoker

Exclusion Criteria:

  • Taking a TZD dose greater than what is indicated
  • Have not taken insulin within 6 months of entry into study
  • Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
  • Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
  • Have had pneumonia in the 3 months prior to study entry
  • Systemic glucocorticoid therapy
  • Clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • History of renal transplantation
  • Have an active or untreated malignancy
  • Have a current diagnosis or past history of clinically relevant pulmonary disease
  • Taking or have taken exenatide during the 6 weeks prior to study entry
  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: NCT00437112

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greenbrae, California, United States, 94904
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, New Jersey
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Toms River, New Jersey, United States, 08753
United States, New Mexico
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Albuquerque, New Mexico, United States, 87108
United States, Texas
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New Braunfels, Texas, United States, 78130
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San Antonio, Texas, United States, 78229
Brazil
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Porto Alegre, Brazil, 90035-003
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Sao Paulo, Brazil, 04025-011
India
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Cochin, India, 682026
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Indore, India, 452 003
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Pune, India, 411005
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vellore, India, 632 004
Puerto Rico
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Manatí, Puerto Rico, 00674
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San Juan, Puerto Rico, 00907
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barakaldo, Spain, 48903
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dos Hermanas, Spain, 41014
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, Spain, 28006
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Requena, Spain, 46340
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sabadell, Spain, 08208
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 from 9AM - 5PM 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: NCT00437112     History of Changes
Other Study ID Numbers: 9631, H7U-MC-IDAZ
Study First Received: February 16, 2007
Last Updated: July 15, 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 July 24, 2014