NCT00325364

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2006

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
11 countries

43 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

May 10, 2006

Last Update Submit

September 6, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin

    6 months

Secondary Outcomes (9)

  • To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin

    24 months

  • To compare inhaled human insulin to injectable insulin over time with respect to change on body weight

    baseline and every visit

  • To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction

    baseline, 6 months, 12 months, 18 months, 24 months

  • To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c

    baseline and every visit

  • 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

    throughout the study

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Human Insulin Inhalation Powder

2

ACTIVE COMPARATOR
Drug: Injectable insulin

Interventions

Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 24 months

Also known as: LY041001
1
Injectable insulinDRUG

patient specific dose, injectable, before meals, 24 months

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Non smoker
  • Normal lung function

You may not qualify if:

  • Pulmonary, hepatic, or renal disease
  • Congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sacramento, California, 95825, United States

Location

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Santa Ana, California, 92705, United States

Location

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Jacksonville, Florida, 32204, United States

Location

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Miami, Florida, 33156, United States

Location

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Baton Rouge, Louisiana, 70808, United States

Location

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Hamilton, New Jersey, 08610, United States

Location

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Greenville, South Carolina, 29605, United States

Location

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Ogden, Utah, 84403, United States

Location

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Charleston, West Virginia, 25304, United States

Location

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Fortaleza, 60120-020, Brazil

Location

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Porto Alegre, 90035-003, Brazil

Location

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São Paulo, 04020041, Brazil

Location

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Berlin, 10115, Germany

Location

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Dresden, 01307, Germany

Location

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Erlangen, 91054, Germany

Location

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Frankfurt, 60596, Germany

Location

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Leipzig, D-04103, Germany

Location

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Mainz, D-55116, Germany

Location

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Budapest, H-1139, Hungary

Location

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Makó, 6900, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Zalaegerszeg, 8900, Hungary

Location

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Bangalore, 560010, India

Location

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Mumbai, 400 007, India

Location

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Pune, 411005, India

Location

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Catania, 95100, Italy

Location

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Genova, 16132, Italy

Location

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Milan, 20132, Italy

Location

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Pisa, 56100, Italy

Location

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Rome, 00168, Italy

Location

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Mexico City, 06700, Mexico

Location

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Monterrey, 64410, Mexico

Location

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Katowice, 40-044, Poland

Location

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Lublin, 20-954, Poland

Location

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Oleśnica, Poland

Location

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Coimbra, 3000-076, Portugal

Location

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Lisbon, 1250-203, Portugal

Location

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Manatí, 00674, Puerto Rico

Location

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San Juan, 00907, Puerto Rico

Location

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Yabucoa, 00767, Puerto Rico

Location

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Changhua, 500, Taiwan

Location

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Neihu Taipei, 114, Taiwan

Location

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Yungkang City, 710, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 19772446RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 12, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

PR(3)PL(3)ME(2)DE(6)IT(5)IN(3)HU(4)TW(3)BR(3)PT(2)US(9)