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

Study Overview
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Brief Summary
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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.

Official Title
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Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Drug: metformin\pioglitazone\exenatide
* Drug: metformin, glyburide and glargine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple Therapy<br>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<br>* metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c < 6.5%<br>|
| Active Comparator: conventional therapy<br>sequential addition of metformin, glyburide and basal insulin | Drug: metformin, glyburide and glargine<br>* 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%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in HbA1c level | 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 | at the end of the study (3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment failure | subjects with HbA1c >6.5 at 6 months and 3 years are considered treatment failure | at 6 months and 3 years | 
| hypoglycemic events | asymptomatic hypoglycemic events with documented PGC < 60 mg/dl and sympotomatic hypoglycemia | during the entire study (3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, new onset, combination therapy, new onset type 2 diabetes