NCT00127634

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 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
6 countries

61 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

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
2.7 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

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

2.8 years

First QC Date

August 4, 2005

Last Update Submit

March 7, 2018

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.

    24 months

Secondary Outcomes (11)

  • 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).

    24 months

  • 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

    24 months

  • 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

    24 months

  • 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.

    24 months

  • 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 %.

    24 months

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Human Insulin Inhalation PowderDrug: Insulin Glargine

2

ACTIVE COMPARATOR
Drug: Injectable InsulinDrug: Insulin Glargine

Interventions

Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 24 months, up to 36 months

Also known as: LY041001
1
Injectable InsulinDRUG

patient specific dose, injectable, before meals, 24 months, up to 36 months.

2
Insulin GlargineDRUG

patient specific dose, injectable, as needed, 24 months up to 36 months

12

Eligibility Criteria

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

You may qualify if:

  • Type 1 diabetes
  • Non smoker
  • Normal lung function

You may not qualify if:

  • Significant pulmonary, hepatic, or renal disease
  • Severe congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (61)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sacramento, California, United States

Location

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Walnut Creek, California, United States

Location

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Aurora, Colorado, United States

Location

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Denver, Colorado, United States

Location

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Newark, Delaware, United States

Location

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Hollywood, Florida, United States

Location

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Jacksonville, Florida, 32204, United States

Location

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Largo, Florida, United States

Location

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New Port Richey, Florida, United States

Location

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West Palm Beach, Florida, United States

Location

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Atlanta, Georgia, United States

Location

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Idaho Falls, Idaho, United States

Location

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Chicago, Illinois, United States

Location

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Springfield, Illinois, United States

Location

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Indianapolis, Indiana, United States

Location

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Louisville, Kentucky, United States

Location

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Baltimore, Maryland, United States

Location

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St Louis, Missouri, United States

Location

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Omaha, Nebraska, United States

Location

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North Plainfield, New Jersey, 07060, United States

Location

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Flushing, New York, 11365, United States

Location

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Lake Success, New York, United States

Location

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New Hyde Park, New York, United States

Location

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Staten Island, New York, United States

Location

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Morehead City, North Carolina, 28557, United States

Location

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Raleigh, North Carolina, United States

Location

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Medford, Oregon, United States

Location

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Downingtown, Pennsylvania, United States

Location

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Sellersville, Pennsylvania, 34652, United States

Location

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Sioux Falls, South Dakota, United States

Location

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Dallas, Texas, United States

Location

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Houston, Texas, United States

Location

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San Antonio, Texas, United States

Location

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Renton, Washington, 98055, United States

Location

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Milwaukee, Wisconsin, 53209, United States

Location

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Aalst, Belgium

Location

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Arlon, Belgium

Location

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Brussels, Belgium

Location

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Edegem, Belgium

Location

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Leuven, Belgium

Location

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Liège, Belgium

Location

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Winnipeg, Manitoba, Canada

Location

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Corunna, Ontario, Canada

Location

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Niagara Falls, Ontario, Canada

Location

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Peterborough, Ontario, Canada

Location

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Sarnia, Ontario, Canada

Location

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Montreal, Quebec, Canada

Location

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Zagreb, Croatia

Location

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Budapest, Hungary

Location

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Debrecen, Hungary

Location

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Eger, Hungary

Location

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Gyula, Hungary

Location

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Kecskemét, Hungary

Location

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Nyíregyháza, Hungary

Location

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Szeged, Hungary

Location

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Szolnok, Hungary

Location

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Bangalore, India

Location

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Kochi, India

Location

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Mumbai, India

Location

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New Dehli, India

Location

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Noida, India

Location

Related Publications (1)

  • 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. doi: 10.1089/dia.2009.0040.

    PMID: 19772449DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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

August 4, 2005

First Posted

August 8, 2005

Study Start

July 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

HU(8)IN(5)US(35)BE(6)CA(6)CR(1)