Skip to main content
OpenTrials
Completed

NCT Number: NCT00157339

Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Asthma Bronchial Diseases Chronic Disease Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract 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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 or type 2 diabetes
  • asthma or COPD

Exclusion criteria

  • Current smoking habit

Treatment and study plan

Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals, 12 months

Other names: LY041001

injected insulin

Drug

patient specific dose, injected, before meals, 12 months.

Primary outcomes

  1. To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.

    Time frame: 12 months

Secondary outcomes

  1. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.

    Time frame: 12 months

  2. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC

    Time frame: 12 months

  3. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.

    Time frame: 12 months

  4. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity

    Time frame: 12 months

  5. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia

    Time frame: 12 months

  6. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays.

    Time frame: 12 months

  7. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire.

    Time frame: 12 months

  8. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale.

    Time frame: 12 months

  9. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %.

    Time frame: 12 months

  10. To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months.

    Time frame: 12 months

  11. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles

    Time frame: 12 months

  12. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin)

    Time frame: 12 months

  13. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status.

    Time frame: 12 months

  14. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization.

    Time frame: 12 months

  15. To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.

    Time frame: throughout the study

  16. To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Sep 17, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.