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

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: NCT01107717
Recruitment Status : Active, not recruiting
First Posted : April 21, 2010
Last Update Posted : March 22, 2023
Sponsor:
Collaborators:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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%


Outcome Measures
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Primary Outcome Measures :
  1. Difference in HbA1c level [ Time Frame: at the end of the study (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


Eligibility Criteria
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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.
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): NCT01107717


Locations
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United States, Texas
Texas Diabetes Institute
San Antonio, Texas, United States, 78229-3900
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
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Principal Investigator: Ralph DeFronzo, MD The University of Texas Health Science Center at San Antonio
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01107717    
Other Study ID Numbers: HSC20080456H
5R01DK103841-03 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Keywords provided by 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:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Pioglitazone
Exenatide
 Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists