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Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM

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ClinicalTrials.gov Identifier: NCT01107717
Recruitment Status : Recruiting
First Posted : April 21, 2010
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE April 21, 2010
Last Update Posted Date August 31, 2018
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Difference in HbA1c level [ Time Frame: at the end of the dtudy (3 years) ]
subjects will be followed for 3 years and the difference in HbA1c between the two arms at 3 years is the primary outcome of the study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01107717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
  • treatment failure [ Time Frame: at 6 months and 3 years ]
    subjects with HbA1c >6.5 at 6 months and 3 years are considered treatment failure
  • hypoglycemic events [ Time Frame: during the entire study (3 years) ]
    asymptomatic hypoglycemic events with documented PGC < 60 mg/dl and sympotomatic hypoglycemia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
Official Title  ICMJE Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes
Brief Summary Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an contributes to the development of many of its complications. Multiple defects, e.g. impaired insulin secretion and impaired insulin action, contribute to the development of the disease. The aim of this study is to test the efficacy and durability of combination of drugs which correct the defects that lead to the development of diabetes on achieving adequate and durable control of blood sugar levels. Achieving adequate and durable control of blood sugar will prevent many of diabetes complications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes
Intervention  ICMJE
  • Drug: metformin\pioglitazone\exenatide
    metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c < 6.5%
  • Drug: metformin, glyburide and glargine
    subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c < 6.5%
Study Arms  ICMJE
  • Experimental: Triple Therapy
    initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
    Intervention: Drug: metformin\pioglitazone\exenatide
  • Active Comparator: conventional therapy
    sequential addition of metformin, glyburide and basal insulin
    Intervention: Drug: metformin, glyburide and glargine
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2010)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subjects with type 2 diabetes diagnosed during the past 2 years,
  • above 18 years of age,
  • drug naive, or have been on metformin less than 3 months

Exclusion Criteria:

  • subjects with type 1 diabetes or GAD positive subjects or subjects with long standing diabetes (>2 years) or subjects who are not drug naive or have been on metformin more than 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01107717
Other Study ID Numbers  ICMJE HSC20080456H
5R01DK103841-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE
  • American Diabetes Association
  • Amylin Pharmaceuticals, LLC.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Ralph DeFronzo, MD The University of Texas Health Science Center at San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date August 2018

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