Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
This study is currently recruiting participants.
Verified January 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborators:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01107717
First received: April 19, 2010
Last updated: January 17, 2013
Last verified: January 2013
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
Drug Information available for:
Metformin
Metformin hydrochloride
Glyburide
Pioglitazone
Pioglitazone hydrochloride
Exenatide
Insulin glargine
U.S. FDA Resources
Further study details as provided by 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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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 2013 |
| Estimated Primary Completion Date: | December 2013 (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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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.
Investigators
| Principal Investigator: | Ralph DeFronzo, MD | The University of Texas Health Science Center at San Antonio |
More Information
Additional Information:
No publications provided
| 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: | DTT20080456H |
| Study First Received: | April 19, 2010 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pioglitazone Exenatide |
Glargine Glyburide Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013