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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: metformin\pioglitazone\exenatide Drug: metformin, glyburide and glargine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Study Start Date : January 2009
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024


Arm Intervention/treatment
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%




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. hypoglycemic events [ Time Frame: during the entire study (3 years) ]
    asymptomatic hypoglycemic events with documented PGC < 60 mg/dl and sympotomatic hypoglycemia



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

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

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
5R01DK103841-03 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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