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
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: NCT00391209

  Show 42 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:
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 July 09, 2014