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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 24, 2006
First Posted Date  ICMJE May 26, 2006
Last Update Posted Date September 16, 2019
Study Start Date  ICMJE June 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
  • To assess acceptance of insulin therapy [ Time Frame: 9 months ]
  • To assess blood sugar control as measured by HbA1c [ Time Frame: baseline, 1,3,5,7,9 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • To assess acceptance of insulin therapy
  • To assess blood sugar control as measured by HbA1c
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
  • To measure changes in HbA1c over time [ Time Frame: baseline, 1,3,5,7,9 months ]
  • To assess safety by review of adverse events [ Time Frame: throughout study ]
  • To assess patient-reported outcomes based on the W-BQ12 questionnaire [ Time Frame: screening, baseline, months 5, and 9 ]
  • To assess patient-reported outcomes based on the DSC-R questionnaire [ Time Frame: screening,baseline, months 5 and 9 ]
  • To assess patient-reported outcomes based on the DTSQ Questionnaire [ Time Frame: Screening,baseline, months 5 and 9 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • To measure changes in HbA1c over time
  • To assess safety by review of adverse events
  • To assess patient-reported outcomes related to diabetes symptoms, diabetes treatment and general well-being
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Human Insulin Inhalation Powder
    patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)
    Other Name: LY041001
  • Drug: Insulin
    patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)
Study Arms  ICMJE
  • Experimental: 1
    Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.
    Intervention: Drug: Human Insulin Inhalation Powder
  • Active Comparator: 2
    Treatment Options available on the market.
    Intervention: Drug: Insulin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
1019
Original Enrollment  ICMJE
 (submitted: May 24, 2006)
1000
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Denmark,   India,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00330473
Other Study ID Numbers  ICMJE 9628
H7U-MC-IDAW ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP