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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

August 4, 2005
August 6, 2008
July 2005
May 2008   (final data collection date for primary outcome measure)
To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00127634 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: Human Insulin Inhalation Powder
    patient specific dose, inhaled, before meals, 24 months, up to 36 months
    Other Name: LY041001
  • 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
  • Experimental: 1
    Interventions:
    • Drug: Human Insulin Inhalation Powder
    • Drug: Insulin Glargine
  • Active Comparator: 2
    Interventions:
    • Drug: Injectable Insulin
    • Drug: Insulin Glargine
Garg SK, Mathieu C, Rais N, Gao H, Tobian JA, Gates JR, Ferguson JA, Webb DM, Berclaz PY. Two-year efficacy and safety of AIR inhaled insulin in patients with type 1 diabetes: An open-label randomized controlled trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S5-S16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
385
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Croatia,   Hungary,   India
 
NCT00127634
6120, H7U-MC-IDAH
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Alkermes, Inc.
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
Eli Lilly and Company
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP