Phase 4
N=318
Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01107717 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: HbA1c Level — 6.9; 6.4 percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- metformin\pioglitazone\exenatide (Drug); metformin, glyburide and glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Level |
6.9; 6.4 | — |
| SECONDARY Treatment Failure |
33; 59 | — |
| SECONDARY Percentage of Patients With Reported Hypoglycemic Events |
14; 52 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01107717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.