Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Alkermes
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127634
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| Zagreb, Croatia | |
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| Budapest, Hungary | |
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| Debrecen, Hungary | |
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| Eger, Hungary | |
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| Gyula, Hungary | |
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| Kecskemet, Hungary | |
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| Nyiregyhaza, Hungary | |
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| Szeged, Hungary | |
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| Szolnok, Hungary | |
| India | |
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| Bangalore, India | |
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| Kochin, India | |
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| Mumbai, India | |
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| New Dehli, India | |
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| Noida, India | |
Sponsors and Collaborators
Eli Lilly and Company
Alkermes
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 Glargine Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013