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GLP-1 agonist

Mediterranean Diet/GLP1a/Metformin for Diabetes

Phase 4

Waitlist Available

Led By Tracey McLaughlin, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* BMI ≥23 (≥22 in Asians) kg/m2 but \< 45 kg/m2

* HbA1c 5.7-8.0% while not on antihyperglycemic medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at month 0, month 4, month 8, month 11, month 15, month 18

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease

Who is the study for?

This trial is for individuals with prediabetes or mild diabetes (HbA1c levels between 5.7-7.0). It aims to identify different subtypes of type 2 diabetes and tailor treatments accordingly. Participants will undergo a series of tests and receive three first-line treatments: a Mediterranean diet, metformin, and a GLP-1 agonist over the course of five years.

What is being tested?

The study is testing how well participants with varying underlying diabetic physiology respond to three interventions: dietary changes through the Mediterranean diet, the medication metformin, and GLP-1 agonists—a type of medication that affects insulin secretion. The goal is to see which treatment works best for specific diabetic subphenotypes.

What are the potential side effects?

Possible side effects include minor discomfort from blood tests, gastrointestinal issues such as nausea or diarrhea from medications like metformin or GLP-1 agonists, and slight radiation exposure during DXA body scans used in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 0, month 4, month 8, month 11, month 15, month 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 0, month 4, month 8, month 11, month 15, month 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 0, month 4, month 8, month 11, month 15, month 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c

Secondary study objectives

Change in Blood Pressure

Change in LDL Cholesterol

Change in Time in Range (TIR)

+8 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Metformin/Mediterranean Diet/GLP1aExperimental Treatment3 Interventions

1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 2. 3 months washout 3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. 4. 3 months washout 5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.

Group II: Mediterranean Diet/GLP1a/MetforminExperimental Treatment3 Interventions

1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. 2. 3 months washout 3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 4. 3 months washout 5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.

Group III: GLP1a/Metformin/Mediterranean DietExperimental Treatment3 Interventions

1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 2. 3 months washout 3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 4. 3 months washout 5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 2Eligibility criteria met