NCT00157339

Brief Summary

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 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

Strong global presence with extensive site network
Enrollment
299

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

Timeline
Completed

Started Aug 2005

Typical duration for phase_3 diabetes-mellitus

Geographic Reach
16 countries

101 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

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.6 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 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

September 7, 2005

Last Update Submit

September 9, 2019

Conditions

Diabetes MellitusAsthmaPulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.

    12 months

Secondary Outcomes (16)

  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.

    12 months

  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC

    12 months

  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.

    12 months

  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity

    12 months

  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia

    12 months

  • +11 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Human Insulin Inhalation Powder

2

ACTIVE COMPARATOR
Drug: injected insulin

Interventions

Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 12 months

Also known as: LY041001
1
injected insulinDRUG

patient specific dose, injected, before meals, 12 months.

2

Eligibility Criteria

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

You may qualify if:

  • Type 1 or type 2 diabetes
  • asthma or COPD

You may not qualify if:

  • Current smoking habit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (101)

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Montgomery, Alabama, 36106, United States

Location

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Burbank, California, 91505, United States

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Greenbrae, California, 94904, United States

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Norwich, Connecticut, 06360, United States

Location

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Clearwater, Florida, 33756, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32204, United States

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New Port Richey, Florida, 34652, United States

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Ocala, Florida, 34471, United States

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West Palm Beach, Florida, 33401, United States

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Belvidere, Illinois, 61008, United States

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Chicago, Illinois, 60631, United States

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Springfield, Illinois, 62704, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40213, United States

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Baltimore, Maryland, 21204, United States

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Brockton, Massachusetts, 02301, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89146, United States

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Charlotte, North Carolina, 28204, United States

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Morehead City, North Carolina, 28557, United States

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Kettering, Ohio, 45429, United States

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Medford, Oregon, 97504, United States

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Downingtown, Pennsylvania, 19335, United States

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Levittown, Pennsylvania, 19056, United States

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Sellersville, Pennsylvania, 18960, United States

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Simpsonville, South Carolina, 29681, United States

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Spartanburg, South Carolina, 29303, United States

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Sioux Falls, South Dakota, 57105, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77090, United States

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Humble, Texas, 77338, United States

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Midland, Texas, 79705, United States

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San Antonio, Texas, 78229, United States

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Norfolk, Virginia, 23502, United States

Location

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Tacoma, Washington, 98405, United States

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Buenos Aires, C1181ACH, Argentina

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Córdoba, 5000, Argentina

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Mendoza, 5500, Argentina

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Ramos Mejía, B1704ETD, Argentina

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Haskovo, 6300, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4003, Bulgaria

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Sofia, 1606, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Winnipeg, Manitoba, R3E 3P4, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Corunna, Ontario, N0N 1G0, Canada

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Niagara Falls, Ontario, L2G1J4, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Longueuil, Quebec, J4N 1E1, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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San Miguel, S/N, Chile

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Viña del Mar, 2570017, Chile

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Bogotá, Colombia

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Zagreb, HR-10000, Croatia

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Kwun Tong, Hong Kong

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Budapest, 1076, Hungary

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Eger, 3300, Hungary

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Gyula, 5701, Hungary

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Kalocsa, 6300, Hungary

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Kecskemét, 6000, Hungary

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Nyíregyháza, H-4400, Hungary

Location

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Székesfehérvár, 8000, Hungary

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Szolnok, 5000, Hungary

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Ahmedabad, 38009, India

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Bangalore, 560017, India

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Chennai, 600010, India

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Coimbatore, 643209, India

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Gandhinagar, 382428, India

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Hyderabaad, 500033, India

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Kochi, 682026, India

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Kolkata, 700054, India

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Kormangala, 560034, India

Location

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Mangalore, 575001, India

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Mumbai, 400016, India

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Nagpur, 440012, India

Location

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New Delhi, 110057, India

Location

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Noida, 201301, India

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P.O Ernakulam, 682304, India

Location

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Porur, 600116, India

Location

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Pune, 411011, India

Location

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Secunderabad, 800003, India

Location

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Tamil Nadu, 600 006, India

Location

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Vellore, 632 004, India

Location

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.

Mexico City, 11650, Mexico

Location

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.

Monterrey, 64460, Mexico

Location

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Barangay Pembo, 1218, Philippines

Location

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Dillman, Philippines

Location

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Ermita, Philippines

Location

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España, Philippines

Location

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Manila, 1007, Philippines

Location

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Pasig, Philippines

Location

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Quezon City, 1102, Philippines

Location

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San Juan City, Philippines

Location

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Ponce, 00732, Puerto Rico

Location

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Singapore, 159964, Singapore

Location

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Taichung, 407, Taiwan

Location

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Bangkok, 10330, Thailand

Location

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Bangkoknoi, 10700, Thailand

Location

Related Publications (1)

  • Ang E, Lawrence MK, Heilmann CR, Ferguson JA, Tobian JA, Webb DM, Berclaz PY. Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S35-44. doi: 10.1089/dia.2009.0054.

    PMID: 19772447RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusAsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hour, 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

September 7, 2005

First Posted

September 12, 2005

Study Start

August 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

September 17, 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

HU(8)CA(7)TH(2)HK(1)AR(4)CL(2)CR(1)ME(2)PR(1)CO(1)TW(1)PH(8)BU(6)US(36)SG(1)IN(20)