Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00127634
First received: August 4, 2005
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Human Insulin Inhalation Powder
Drug: Injectable Insulin
Drug: Insulin Glargine
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 Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to FEV1, FVC, and total lung capacity (TLC), and diffusing capacity of the lung for carbon monoxide (DLCO). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by insulin antibody binding levels, adverse events, and episodes of hypoglycemia [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety using serial HRCT scans of the chest [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by Six-Minute Walk Test with the Borg CR10 scale to access perceived exertion. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to proportion of patients who achieve or maintain an HbA1c < 7.0 %. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to insulin dose requirements ( total, preprandial, and basal insulin) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To explore differences in cough and other pulmonary symptoms in patients treated with Human Insulin Inhalation Powder or preprandial injectable insulin using the Pulmonary Symptom Questionnaire. [ Time Frame: months 32, 38, 40 and ED visits ] [ Designated as safety issue: No ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to glycemic control as assessed by the 8-point self-monitored blood glucose profiles [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: July 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, 24 months, up to 36 months
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months
Active Comparator: 2 Drug: Injectable Insulin
patient specific dose, injectable, before meals, 24 months, up to 36 months.
Drug: Insulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months

  Eligibility

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

Inclusion Criteria:

  • Type 1 diabetes
  • Non smoker
  • Normal lung function

Exclusion Criteria:

  • Significant pulmonary, hepatic, or renal disease
  • Severe congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy
  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: NCT00127634

  Show 61 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00127634     History of Changes
Other Study ID Numbers: 6120, H7U-MC-IDAH
Study First Received: August 4, 2005
Last Updated: August 6, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014