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GLP-1 Receptor Agonist

Combination Therapy for Type 2 Diabetes

Phase 4
Waitlist Available
Led By Ralph DeFronzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with type 2 diabetes diagnosed during the past 2 years
Drug naive, or have been on metformin less than 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the entire study (3 years)
Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they can effectively and durably control blood sugar levels in people with type 2 diabetes, which would prevent many of the complications associated with the disease.

Who is the study for?
This trial is for adults over 18 who were recently diagnosed with type 2 diabetes within the last two years and are either new to treatment or have been on metformin for less than three months. It's not open to those with type 1 diabetes, GAD positive individuals, anyone with a longer history of diabetes (>2 years), or patients previously treated with drugs other than metformin or for longer periods.Check my eligibility
What is being tested?
The study compares the effectiveness of a combination therapy (Exenatide/Pioglitazone/Metformin) versus conventional treatments (metformin alone, glyburide, and glargine) in managing blood sugar levels in newly diagnosed type 2 diabetics. The goal is to see which method provides better and more lasting control of blood sugar.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea from Metformin; weight gain, bone fractures from Pioglitazone; and possible pancreatitis from Exenatide. Glyburide can cause low blood sugar levels while Glargine might lead to injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with type 2 diabetes within the last 2 years.
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You haven't taken any medication for the condition, or you have been taking metformin for less than 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the study (3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the study (3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in HbA1c level
Secondary outcome measures
hypoglycemic events
treatment failure

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Triple TherapyExperimental Treatment1 Intervention
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
Group II: conventional therapyActive Control1 Intervention
sequential addition of metformin, glyburide and basal insulin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
metformin\pioglitazone\exenatide
2009
Completed Phase 4
~530

Find a Location

Who is running the clinical trial?

Amylin Pharmaceuticals, LLC.Industry Sponsor
40 Previous Clinical Trials
1,544 Total Patients Enrolled
4 Trials studying Diabetes
75 Patients Enrolled for Diabetes
American Diabetes AssociationOTHER
137 Previous Clinical Trials
98,981 Total Patients Enrolled
16 Trials studying Diabetes
1,346 Patients Enrolled for Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,318,953 Total Patients Enrolled
106 Trials studying Diabetes
138,142 Patients Enrolled for Diabetes

Media Library

Exenatide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT01107717 — Phase 4
Diabetes Research Study Groups: conventional therapy, Triple Therapy
Diabetes Clinical Trial 2023: Exenatide Highlights & Side Effects. Trial Name: NCT01107717 — Phase 4
Exenatide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01107717 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research restricted to individuals over a certain age?

"The requirements to take part in this medical experiment necessitate that the participants are between 18 and 80 years old. Additionally, there are 221 clinical trials tailored towards those under 18 years of age and 1119 studies dedicated to individuals over 65."

Answered by AI

Are there still vacancies in this clinical research endeavor?

"Unfortunately, this clinical trial is not accepting new enrollees at the present moment. The study was first posted in 2009 and had its last update on March 8th 2022. On the other hand, if you are looking for additional trials to join, 1266 studies recruiting people with diabetes mellitus are currently operational and 215 of them have openings pertaining to metformin-pioglitazone-exenatide combinations."

Answered by AI

What are the requirements for participants to be eligible in this medical research study?

"This trial is seeking 521 diabetics between 18 and 80 years old. Applicants must have been recently diagnosed within the past 2 years, not taken any diabetes medication for at least 3 months or be drug naive, and exceed 18 years of age to qualify."

Answered by AI

Are there any prior studies that have explored the usage of metformin, pioglitazone, or exenatide?

"Presently, 215 clinical studies are underway regarding metformin\pioglitazone\exenatide. 53 of these experiments have advanced to Phase 3 with the majority occurring in Chicago, Illinois. Across 2271 medical sites worldwide this medication is being tested."

Answered by AI

Have any of the medications metformin, pioglitazone, or exenatide been given clearance by regulators?

"Considering that this is a Phase 4 trial and the treatment has already been approved, our team at Power rated its safety as 3 on a scale of 1 to 3."

Answered by AI

What is the aggregate enrolment for this research project?

"Currently, the trial is not accruing participants. It was established on January 1st 2009 and updated most recently on March 8th 2022. If you are seeking alternative studies, there are a total of 1266 trials currently enrolling patients with diabetes mellitus and 215 that involve metformin/pioglitazone/exenatide as treatments."

Answered by AI

In what circumstances are metformin\pioglitazone\exenatide typically prescribed?

"To ameliorate diabetes, exercise-related issues, and type 1 diabetes mellitus respectively, metformin, pioglitazone, and exenatide can be deployed."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Diabetes Institute
What portion of applicants met pre-screening criteria?
Met criteria
~32 spots leftby Mar 2025