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

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ClinicalTrials.gov Identifier: NCT00330473
Recruitment Status : Completed
First Posted : May 26, 2006
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Human Insulin Inhalation Powder Drug: Insulin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1019 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options
Study Start Date : June 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.
 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)
Other Name: LY041001
Active Comparator: 2
Treatment Options available on the market.
 Drug: Insulin
patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)


Outcome Measures
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Primary Outcome Measures :
  1. To assess acceptance of insulin therapy [ Time Frame: 9 months ]
  2. To assess blood sugar control as measured by HbA1c [ Time Frame: baseline, 1,3,5,7,9 months ]

Secondary Outcome Measures :
  1. To measure changes in HbA1c over time [ Time Frame: baseline, 1,3,5,7,9 months ]
  2. To assess safety by review of adverse events [ Time Frame: throughout study ]
  3. To assess patient-reported outcomes based on the W-BQ12 questionnaire [ Time Frame: screening, baseline, months 5, and 9 ]
  4. To assess patient-reported outcomes based on the DSC-R questionnaire [ Time Frame: screening,baseline, months 5 and 9 ]
  5. To assess patient-reported outcomes based on the DTSQ Questionnaire [ Time Frame: Screening,baseline, months 5 and 9 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330473


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00330473    
Other Study ID Numbers: 9628
H7U-MC-IDAW ( Other Identifier: Eli Lilly and Company )
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs