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A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

NCT ID: NCT00330473

Last Updated: 2019-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1019 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Human Insulin Inhalation Powder

Intervention Type DRUG

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

2

Treatment Options available on the market.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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

Interventions

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Human Insulin Inhalation Powder

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

Intervention Type DRUG

Insulin

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

Intervention Type DRUG

Other Intervention Names

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LY041001

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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, United States

Site Status

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Pomona, California, United States

Site Status

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Jacksonville, Florida, United States

Site Status

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New Port Richey, Florida, United States

Site Status

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Orlando, Florida, United States

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Chicago Heights, Illinois, United States

Site Status

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Peoria, Illinois, United States

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Lafayette, Indiana, United States

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Topeka, Kansas, United States

Site Status

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Metairie, Louisiana, United States

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Pasadena, Maryland, United States

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Rockville, Maryland, United States

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Billerica, Massachusetts, United States

Site Status

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Butte, Montana, United States

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New York, New York, United States

Site Status

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Westfield, New York, United States

Site Status

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Corvallis, Oregon, United States

Site Status

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Medford, Oregon, United States

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Corpus Christi, Texas, United States

Site Status

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Houston, Texas, United States

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Gig Harbor, Washington, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

Site Status

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Tacoma, Washington, United States

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Buenos Aires, , Argentina

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Belo Horizonte, , Brazil

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Campinas, , Brazil

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Fortaleza, , Brazil

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Rio de Janeiro, , Brazil

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Setor Oeste/Goiania, , Brazil

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

Site Status

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Kingston, Ontario, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Aarhus, , Denmark

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Hellerup, , Denmark

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Hvidovre, , Denmark

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Koege, , Denmark

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Ahmedabad, , India

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Bangalore, , India

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Chennai, , India

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Pune, , India

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Monterrey, , Mexico

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Katowice, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Bayamón, , Puerto Rico

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Carolina, , Puerto Rico

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Rio Piedras, , Puerto Rico

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San Juan, , Puerto Rico

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Moscow, , Russia

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Saint Petersburg, , Russia

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Cape Town, , South Africa

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Pretoria, , South Africa

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Seoul, , South Korea

Site Status

Countries

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United States Argentina Brazil Canada Denmark India Mexico Poland Puerto Rico Russia South Africa South Korea

References

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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.

Reference Type RESULT
PMID: 19772448 (View on PubMed)

Other Identifiers

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H7U-MC-IDAW

Identifier Type: OTHER

Identifier Source: secondary_id

9628

Identifier Type: -

Identifier Source: org_study_id

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