NCT00355849

Brief Summary

A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
555

participants targeted

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

Timeline
Completed

Started Aug 2006

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
12 countries

69 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

First Submitted

Initial submission to the registry

July 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

July 21, 2006

Last Update Submit

September 6, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.

    24 weeks

Secondary Outcomes (3)

  • To measure changes in HbA1c over time

    24 weeks

  • To assess insulin dose requirements

    24 and 52 weeks

  • To assess rate and incidence of hypoglycemia

    24 and 52 weeks

Study Arms (3)

1

EXPERIMENTAL

Intensified Glargine

Drug: Insulin Glargine

2

EXPERIMENTAL

HIIP

Drug: Human Insulin Inhalation Powder

3

EXPERIMENTAL

Intensified Glargine plus HIIP

Drug: Human Insulin Inhalation PowderDrug: Insulin Glargine

Interventions

Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 52 weeks

Also known as: LY041001
23
Insulin GlargineDRUG

patient specific dose, injectable, before meals, 52 weeks

13

Eligibility Criteria

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

You may qualify if:

  • type 2 diabetes mellitus
  • one or more oral antihyperglycemic medications
  • once-daily insulin glargine
  • HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
  • Non-smoker

You may not qualify if:

  • taking a TZD dose greater than what is indicated
  • more than two episodes of severe hypoglycemia during the 6 months prior
  • Have had a lower respiratory infection in the 3 months prior
  • systemic glucocorticoid therapy
  • clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • history of renal transplantation
  • Have an active or untreated malignancy
  • Require more than 150 U/day of insulin glargine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (69)

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Fresno, California, 93720, United States

Location

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Pomona, California, 91767, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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Atlanta, Georgia, 30309, United States

Location

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Peoria, Illinois, 61615, United States

Location

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New Albany, Indiana, 47150, United States

Location

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Topeka, Kansas, 66606, United States

Location

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Metairie, Louisiana, 70006, United States

Location

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Ann Arbor, Michigan, 48108, United States

Location

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Grand Rapids, Michigan, 49503, United States

Location

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Omaha, Nebraska, 68131, United States

Location

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Nashua, New Hampshire, 03063, United States

Location

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Cherry Hill, New Jersey, 08002, United States

Location

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Flemington, New Jersey, 08822, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

Location

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Austin, Texas, 78731, United States

Location

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Dallas, Texas, 75230, United States

Location

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Georgetown, Texas, 78626, United States

Location

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New Braunfels, Texas, 78130, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Midvale, Utah, 84047, United States

Location

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Ogden, Utah, 84403, United States

Location

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Salt Lake City, Utah, 84107, United States

Location

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Olympia, Washington, 98506, United States

Location

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Curitiba, 80060-900, Brazil

Location

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São Paulo, 04020041, Brazil

Location

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Red Deer, Alberta, T4N 6V7, Canada

Location

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Saint John, New Brunswick, E2L 4L2, Canada

Location

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Cambridge, Ontario, N2R 7L6, Canada

Location

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Thornhill, Ontario, L4J 8L7, Canada

Location

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Sainte-Foy, Quebec, G1V 4G2, Canada

Location

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Aschaffenburg, 63739, Germany

Location

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Berlin, 10115, Germany

Location

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Dresden, 01307, Germany

Location

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Hamburg, 22607, Germany

Location

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Mainz, D-55116, Germany

Location

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Münster, 48145, Germany

Location

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Rodgau, D-63110, Germany

Location

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Witten, 58455, Germany

Location

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Bangalore, 560038, India

Location

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Chennai, 600 010, India

Location

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Indore, 452 003, India

Location

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Ludhiana, 141001, India

Location

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Holon, 22100, Israel

Location

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Nahariya, 22100, Israel

Location

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Tel Litwinsky, 52621, Israel

Location

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Carolina, 00983, Puerto Rico

Location

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Manatí, 00674, Puerto Rico

Location

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San Juan, 00907, Puerto Rico

Location

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Toa Baja, 00950, Puerto Rico

Location

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Moscow, 125315, Russia

Location

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Saint Petersburg, 195176, Russia

Location

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Pretoria, 0083, South Africa

Location

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Seoul, 137-701, South Korea

Location

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Suwon, 442-721, South Korea

Location

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A Coruña, 15006, Spain

Location

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Alicante, 03114, Spain

Location

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Alzira, 46220, Spain

Location

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Barcelona, 08017, Spain

Location

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Dos Hermanas, 41014, Spain

Location

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Madrid, 28006, Spain

Location

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Palma de Mallorca, 07198, Spain

Location

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Middlesbrough, Cleveland, TS4 3BW, United Kingdom

Location

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Blackburn, East Lancashire, BB2 3HH, United Kingdom

Location

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Penarth, South Glamorgan, CF64 2XX, United Kingdom

Location

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Swansea, Wales, SA6 6NL, United Kingdom

Location

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Livingston, West Lothian, EH54 6PP, United Kingdom

Location

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Birmingham, West Midlands, B9 5SS, United Kingdom

Location

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Manchester, M41 5SL, United Kingdom

Location

Related Publications (1)

  • Rosenstock J, Eliaschewitz FG, Heilmann CR, Muchmore DB, Hayes RP, Belin RM. Comparison of prandial AIR inhaled insulin alone to intensified insulin glargine alone and to AIR insulin plus intensified insulin glargine in patients with type 2 diabetes previously treated with once-daily insulin glargine. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S63-73. doi: 10.1089/dia.2009.0059.

    PMID: 19772451RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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

July 21, 2006

First Posted

July 25, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 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

ES(7)RU(2)BR(2)PR(4)KR(2)IN(4)IL(3)DE(8)GB(7)US(24)CA(5)ZA(1)