NCT00391209

Brief Summary

This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups: Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day. Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2006

Geographic Reach
9 countries

42 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

October 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
1.5 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

1.6 years

First QC Date

October 19, 2006

Last Update Submit

March 7, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.

    6 months

Secondary Outcomes (9)

  • Mean change in HbA1c from baseline to various endpoints.

    6 months

  • Patient safety

    throughout the study

  • Patient reported outcome from W-BQ12

    screening,baseline,month 6

  • Treatment satisfaction

    6 months

  • Insulin dose

    throughout the study

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder

2

EXPERIMENTAL
Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder

Interventions

simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals,6 months

Also known as: LY041001
1
intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 6 months

Also known as: LY 041001
2

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes mellitus for at least 6 months
  • Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
  • Patients who have been treated with the following regimen:
  • One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones \[TZDs\]),
  • AND
  • have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
  • AND
  • are candidates for insulin therapy, in the opinion of the investigator.

You may not qualify if:

  • Pregnancy
  • Smoker
  • History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
  • Diagnosed with pneumonia in the 3 months prior to screening
  • Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
  • History of renal transplantation
  • History of lung transplantation
  • Active or untreated malignancy
  • Treated with Incretin mimetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

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.

Santa Ana, California, 92705, United States

Location

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Washington D.C., District of Columbia, 20010, United States

Location

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Hollywood, Florida, 33021, United States

Location

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New Port Richey, Florida, 34652, United States

Location

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South Miami, Florida, 33143, United States

Location

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Honolulu, Hawaii, 96813, United States

Location

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Idaho Falls, Idaho, 83404, United States

Location

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New Orleans, Louisiana, 70121, United States

Location

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Biddeford, Maine, 04005, United States

Location

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Minneapolis, Minnesota, 55416, United States

Location

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Stratford, New Jersey, 08084, United States

Location

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Greenville, South Carolina, 29605, United States

Location

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Austin, Texas, 78731, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Salt Lake City, Utah, 84124, United States

Location

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Renton, Washington, 98057, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Buenos Aires, 1012, Argentina

Location

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Vienna, 1090, Austria

Location

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Vienna, A-1030, Austria

Location

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Bruges, 8000, Belgium

Location

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Brussels, 1070, Belgium

Location

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Leuven, 3000, Belgium

Location

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Liège, 4000, Belgium

Location

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La Roche-sur-Yon, 85925, France

Location

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La Rochelle, 17019, France

Location

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Rouen, 76031, France

Location

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Valenciennes, 59322, France

Location

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Ahmedabad, 380006, India

Location

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Bangalore, 560052, India

Location

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Chennai, 600116, India

Location

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Guadalajara, 44670, Mexico

Location

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Monterrey, 64060, Mexico

Location

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Caguas, 00726, Puerto Rico

Location

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Ponce, 00717-2075, Puerto Rico

Location

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Rio Piedras, 00921, Puerto Rico

Location

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A Coruña, 15006, Spain

Location

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Alicante, 03114, Spain

Location

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Alzira, 46600, Spain

Location

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Granada, 18014, Spain

Location

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Palma de Mallorca, 07198, Spain

Location

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Requena, 46340, Spain

Location

Related Publications (1)

  • Naegeli AN, Hayes RP. Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naive patients with type 2 diabetes. Int J Clin Pract. 2010 Jun;64(7):908-16. doi: 10.1111/j.1742-1241.2010.02363.x. Epub 2010 Mar 30.

    PMID: 20370840DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

October 19, 2006

First Posted

October 23, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

AR(1)FR(4)US(17)IN(3)AU(2)PR(3)BE(4)ES(6)ME(2)