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

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00157339
First received: September 7, 2005
Last updated: July 3, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Asthma
Pulmonary Disease, Chronic Obstructive
Drug: Human Insulin Inhalation Powder
Drug: injected insulin
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 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: August 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 12 months
Other Name: LY041001
Active Comparator: 2 Drug: injected insulin
patient specific dose, injected, before meals, 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • asthma or COPD

Exclusion Criteria:

  • Current smoking habit
  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: NCT00157339

  Show 101 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Alkermes, Inc.
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hour, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00157339     History of Changes
Other Study ID Numbers: 7091, H7U-MC-IDAS
Study First Received: September 7, 2005
Last Updated: July 3, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Diabetes Mellitus
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014