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Completed

NCT Number: NCT00391209

Compare Two Dosing Algorithms 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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., Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals,6 months

Other names: LY041001

intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals, 6 months

Other names: LY 041001

Primary outcomes

  1. 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

Secondary outcomes

  1. Mean change in HbA1c from baseline to various endpoints.

    Time frame: 6 months

  2. Patient safety

    Time frame: throughout the study

  3. Patient reported outcome from W-BQ12

    Time frame: screening,baseline,month 6

  4. Treatment satisfaction

    Time frame: 6 months

  5. Insulin dose

    Time frame: throughout the study

  6. Patient reported outcome from DSC-R

    Time frame: screening,baseline, month 6

  7. Patient reported outcome from DTSQS

    Time frame: screening,baseline, month 6

  8. Patient reported outcome from IDSQ

    Time frame: Month 1, 2 and 6

  9. Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"

    Time frame: baseline, screening, month 6

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 23, 2006
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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