NCT00330473

Brief Summary

A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,019

participants targeted

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

Timeline
Completed

Started Jun 2006

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
12 countries

60 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

May 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.9 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

1.9 years

First QC Date

May 24, 2006

Last Update Submit

September 6, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • To assess acceptance of insulin therapy

    9 months

  • To assess blood sugar control as measured by HbA1c

    baseline, 1,3,5,7,9 months

Secondary Outcomes (5)

  • To measure changes in HbA1c over time

    baseline, 1,3,5,7,9 months

  • To assess safety by review of adverse events

    throughout study

  • To assess patient-reported outcomes based on the W-BQ12 questionnaire

    screening, baseline, months 5, and 9

  • To assess patient-reported outcomes based on the DSC-R questionnaire

    screening,baseline, months 5 and 9

  • To assess patient-reported outcomes based on the DTSQ Questionnaire

    Screening,baseline, months 5 and 9

Study Arms (2)

1

EXPERIMENTAL

Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.

Drug: Human Insulin Inhalation Powder

2

ACTIVE COMPARATOR

Treatment Options available on the market.

Drug: Insulin

Interventions

Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)

Also known as: LY041001
1
InsulinDRUG

patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)

2

Eligibility Criteria

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

You may qualify if:

  • Type 2 Diabetes
  • Insulin-naive
  • Non-smoker

You may not qualify if:

  • Significant pulmonary, hepatic or renal disease
  • severe congestive heart failure
  • active malignancy or malignancy within the last 5 years
  • systemic glucocorticoid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (60)

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.

Huntington Beach, California, 92646, United States

Location

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Pomona, California, 91767, United States

Location

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Jacksonville, Florida, 32216, United States

Location

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New Port Richey, Florida, 34652, United States

Location

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Orlando, Florida, 32806, United States

Location

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Chicago Heights, Illinois, 60411, United States

Location

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Peoria, Illinois, 61615, United States

Location

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Lafayette, Indiana, 47904, 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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Pasadena, Maryland, 21122, United States

Location

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Rockville, Maryland, 20854, United States

Location

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Billerica, Massachusetts, 01821, United States

Location

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Butte, Montana, 59701, United States

Location

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New York, New York, 10021, United States

Location

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Westfield, New York, 14787, United States

Location

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Corvallis, Oregon, 97330, United States

Location

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Medford, Oregon, 97504, United States

Location

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Corpus Christi, Texas, 78404, United States

Location

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Houston, Texas, 77005, United States

Location

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Gig Harbor, Washington, 98335, United States

Location

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Olympia, Washington, 98506, United States

Location

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Spokane, Washington, 99202, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Buenos Aires, C1426ABP, Argentina

Location

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Belo Horizonte, Brazil

Location

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Campinas, 13083-990, Brazil

Location

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Fortaleza, 60430-350, Brazil

Location

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Rio de Janeiro, 21941-590, Brazil

Location

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Setor Oeste/Goiania, 74043-110, Brazil

Location

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Edmonton, Alberta, T5J 3N4, Canada

Location

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Winnipeg, Manitoba, R3E 3P4, Canada

Location

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

Location

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Kingston, Ontario, K7L 2V7, Canada

Location

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Mississauga, Ontario, L5B 4A2, Canada

Location

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Ottawa, Ontario, K1H 1A2, Canada

Location

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Windsor, Ontario, N8W 3K2, Canada

Location

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Montreal, Quebec, H2W 1T8, Canada

Location

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Aarhus, 8000, Denmark

Location

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Hellerup, 2900, Denmark

Location

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Hvidovre, 2650, Denmark

Location

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Koege, 4600, Denmark

Location

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Ahmedabad, 380052, India

Location

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Bangalore, 560004, India

Location

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Chennai, 600 013, India

Location

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Pune, 411007, India

Location

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Monterrey, 64700, Mexico

Location

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Katowice, 40-044, Poland

Location

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Lublin, 20-538, Poland

Location

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Warsaw, 03-242, Poland

Location

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Wroclaw, 50-127, Poland

Location

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Bayamón, 00956, Puerto Rico

Location

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Carolina, 00983, Puerto Rico

Location

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Rio Piedras, 00921, Puerto Rico

Location

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San Juan, 00926, Puerto Rico

Location

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Moscow, 119881, Russia

Location

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Saint Petersburg, 193257, Russia

Location

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Cape Town, 7505, South Africa

Location

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Pretoria, 0143, South Africa

Location

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Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Bergenstal RM, Freemantle N, Leyk M, Cutler GB Jr, Hayes RP, Muchmore DB. Does availability of AIR insulin increase insulin use and improve glycemic control in patients with type 2 diabetes? Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S45-52. doi: 10.1089/dia.2009.0028.

    PMID: 19772448RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic 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

May 24, 2006

First Posted

May 26, 2006

Study Start

June 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

ME(1)RU(2)PL(4)US(24)IN(4)AR(1)PR(4)CA(8)DK(4)ZA(2)KR(1)BR(5)