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

This study is currently recruiting participants.
Verified August 2017 by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107717
First Posted: April 21, 2010
Last Update Posted: August 15, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention
Diabetes Drug: metformin\pioglitazone\exenatide Drug: metformin, glyburide and glargine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: January 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple Therapy
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
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%
Active Comparator: conventional therapy
sequential addition of metformin, glyburide and basal insulin
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%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01107717


Locations
United States, Texas
Texas Diabetes Institute Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Muhammad Abdul-Ghani, MD, PhD    210-567-2391    ABDULGHANI@UTHSCSA.EDU   
Contact: Curtiss Puckett, PA    (210) 358 7200    Curtiss.Puckett@uhs-sa.com   
Principal Investigator: Ralph DeFronzo, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
American Diabetes Association
Amylin Pharmaceuticals, LLC.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ralph DeFronzo, MD The University of Texas Health Science Center at San Antonio
  More Information

Additional Information:
Responsible Party: Ralph DeFronzo, Professor, Medicine -Diabetes, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01107717     History of Changes
Other Study ID Numbers: HSC20080456H
First Submitted: April 19, 2010
First Posted: April 21, 2010
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:
type 2 diabetes
new onset
combination therapy
new onset type 2 diabetes

Additional relevant MeSH terms:
Pioglitazone
Exenatide
Metformin
Insulin Glargine
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists


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