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

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

October 19, 2006
January 21, 2010
October 2006
May 2008   (final data collection date for primary outcome measure)
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 ]
Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve within 6 months glycemic control simular to a more aggressive approach.
Complete list of historical versions of study NCT00391209 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mean change in HbA1c from baseline to various endpoints.
  • Patient safety
  • Patient reported outcomes
  • Treatment satisfaction
  • Insulin dose
Not Provided
Not Provided
 
Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
  • Experimental: 2
    Intervention: Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
Naegeli AN, Hayes RP. Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naïve patients with type 2 diabetes. Int J Clin Pract. 2010 Jun;64(7):908-16. doi: 10.1111/j.1742-1241.2010.02363.x. Epub 2010 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
379
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   United States,   Argentina,   Austria,   Belgium,   France,   Spain,   Mexico,   Puerto Rico
 
NCT00391209
9630, H7U-MC-IDAY
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Alkermes, Inc.
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
Eli Lilly and Company
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP