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Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00325364
First received: May 10, 2006
Last updated: November 21, 2016
Last verified: November 2016

May 10, 2006
November 21, 2016
April 2006
May 2008   (final data collection date for primary outcome measure)
To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess the change in baseline to endpoint in HgA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin at 6 months
Complete list of historical versions of study NCT00325364 on ClinicalTrials.gov Archive Site
  • To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare inhaled human insulin to injectable insulin over time with respect to change on body weight [ Time Frame: baseline and every visit ] [ Designated as safety issue: No ]
  • To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
  • To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c [ Time Frame: baseline and every visit ] [ Designated as safety issue: No ]
  • To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To test dose titration methods [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess inhaler reliability [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • To test that inhaled human insulin is non-inferior to preprandial injectable insulin
  • To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
  • To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
  • To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
  • To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
  • To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
  • To test dose titration methods at 6 months
  • To assess inhaler reliability
  • To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Not Provided
Not Provided
 
Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 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 2 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 2
  • Drug: Human Insulin Inhalation Powder
    patient specific dose, inhaled, before meals, 24 months
    Other Name: LY041001
  • Drug: Injectable insulin
    patient specific dose, injectable, before meals, 24 months
  • Experimental: 1
    Intervention: Drug: Human Insulin Inhalation Powder
  • Active Comparator: 2
    Intervention: Drug: Injectable insulin
Gross JL, Nakano M, Colon-Vega G, Ortiz-Carasquillo R, Ferguson JA, Althouse S, Tobian JA, Berclaz PY, Milicevic Z. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S27-34. doi: 10.1089/dia.2009.0037.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
415
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Non smoker
  • Normal lung function

Exclusion Criteria:

  • Pulmonary, hepatic, or renal disease
  • Congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Germany,   Hungary,   India,   Italy,   Mexico,   Poland,   Portugal,   Puerto Rico,   Taiwan
 
NCT00325364
9626, H7U-MC-IDAU
Not Provided
Yes

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Eli Lilly and Company
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
November 2016

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