Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00391209
First received: October 19, 2006
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:

Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.

Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
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, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in HbA1c from baseline to various endpoints. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient safety [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Patient reported outcome from W-BQ12 [ Time Frame: screening,baseline,month 6 ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Insulin dose [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Patient reported outcome from DSC-R [ Time Frame: screening,baseline, month 6 ] [ Designated as safety issue: No ]
  • Patient reported outcome from DTSQS [ Time Frame: screening,baseline, month 6 ] [ Designated as safety issue: No ]
  • Patient reported outcome from IDSQ [ Time Frame: Month 1, 2 and 6 ] [ Designated as safety issue: No ]
  • Patient reported outcome from "Expectations About Insulin Therapy Questionnaire" [ Time Frame: baseline, screening, month 6 ] [ Designated as safety issue: No ]

Enrollment: 379
Study Start Date: October 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,6 months
Other Name: LY041001
Experimental: 2 Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 6 months
Other Name: LY 041001

  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 for at least 6 months
  • Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
  • Patients who have been treated with the following regimen:

One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),

AND

have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,

AND

are candidates for insulin therapy, in the opinion of the investigator.

Exclusion Criteria:

  • Pregnancy
  • Smoker
  • History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
  • Diagnosed with pneumonia in the 3 months prior to screening
  • Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
  • History of renal transplantation
  • History of lung transplantation
  • Active or untreated malignancy
  • Treated with Incretin mimetics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391209

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Locations
United States, California
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Santa Ana, California, United States, 92705
United States, District of Columbia
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Washington, District of Columbia, United States, 20010
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Alcira, Spain, 46600
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Alicante, Spain, 03114
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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:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00391209     History of Changes
Other Study ID Numbers: 9630, H7U-MC-IDAY
Study First Received: October 19, 2006
Last Updated: January 21, 2010
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014