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OpenTrials
Completed

NCT Number: NCT00437112

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

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.

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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., Porto Alegre, Brazil

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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
  • 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

Treatment and study plan

Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals, 24 weeks

Other names: LY041001

insulin glargine

Drug

patient specific dose, injectable, before meals, 24 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. Mean change in HbA1c from baseline to various timepoints

    Time frame: 56 weeks

  2. Insulin dose requirements

    Time frame: 56 weeks

  3. Patient-reported outcomes of W-BQ12

    Time frame: screening,baseline, week 12,24, and 48

  4. Hypoglycemia rate

    Time frame: throughout the study

  5. Changes in body weight

    Time frame: every visit

  6. Adverse events

    Time frame: throughout the study

  7. Safety as assessed by total pulmonary function testing and fasting lipid profile

    Time frame: throughout the study

  8. Assess inhaler reliability.

    Time frame: throughout the study

  9. Patient Reported outcomes of DSC-R

    Time frame: screening,baseline, week 12,24, and 48

  10. Patient reported outcomes of DTSQS

    Time frame: screening,baseline, week 12, 24 and 48

  11. Patient reported outcome of IDSQ

    Time frame: week 12, 24, and 48

  12. Patient reported outcome of preference questionnaire

    Time frame: week 48

  13. Patient reported outcome of Expectations About Insulin Therapy Questionnaire

    Time frame: screening,baseline

  14. Patient reported outcome of Experience with Insulin Therapy Questionnaire

    Time frame: week 12, 24 and 48

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 19, 2007
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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