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Oral Hypoglycemic Therapy for Diabetes

Phase 2 & 3

Waitlist Available

Led By George L. King, MD

Research Sponsored by Joslin Diabetes Center

Eligibility Criteria Checklist

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

Must have

Capable of giving informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 6 months

Awards & highlights

Study Summary

This trial is testing whether adding a diabetes medication to existing insulin treatment can help people with a specific gene variation who have had diabetes for 50 years or more.

Who is the study for?

This trial is for people who have had Type 1 Diabetes for over 50 years and are part of the Joslin Medalist Study. They must live in the US, be able to consent, and have a minimal level of C-peptide. Those with severe liver disease, cognitive issues, organ transplants, cancer, inflammatory diseases, recent heart or stroke events, high blood pressure or advanced kidney disease can't join.Check my eligibility

What is being tested?

The study tests if adding oral diabetes pills (Metformin Extended Release or Sitagliptin) to insulin helps control blood sugar in long-term Type 1 diabetics with certain genetic traits. It checks if specific immune system genes affect pill effectiveness.See study design

What are the potential side effects?

Possible side effects include digestive upset from Metformin like nausea or diarrhea and low blood sugar risk. Sitagliptin may cause joint pain, skin reactions or pancreatitis but these are less common.

Eligibility Criteria

Inclusion Criteria

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

Select...

I understand the study and can agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glycated hemoglobin (HbA1c)

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC) of C-peptide

Body mass index (BMI)

C-peptide

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: HLA- GroupExperimental Treatment2 Interventions

Participants who are high-risk HLA-DR3 and DR4 (-); with known or yet unknown monogenic variants with REVEL score>0.75; and either GAD65 and IA2 autoantibody (-), or autoantibody (+) with titers close to the cutoff

Group II: HLA+ GroupExperimental Treatment2 Interventions

Participants who are high-risk HLA-DR3 and/or DR4 (+); monogenic variant (+) with rare exome variant ensemble learner (REVEL) score>0.75; and both glutamic acid decarboxylase (GAD65) and islet antigen (IA2) autoantibody (-)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin Extended Release Oral Tablet

2018

Completed Phase 4

~50

Sitagliptin

2011

Completed Phase 4

~10170

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joslin Diabetes CenterLead Sponsor

96 Previous Clinical Trials

26,552 Total Patients Enrolled

11 Trials studying Diabetes

1,135 Patients Enrolled for Diabetes

George L. King, MDPrincipal InvestigatorJoslin Diabetes Center

Media Library

HLA+ Group Clinical Trial Eligibility Overview. Trial Name: NCT04409795 — Phase 2 & 3

Diabetes Research Study Groups: HLA+ Group, HLA- Group

Diabetes Clinical Trial 2023: HLA+ Group Highlights & Side Effects. Trial Name: NCT04409795 — Phase 2 & 3

HLA+ Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04409795 — Phase 2 & 3

Frequently Asked Questions

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

What is the main illness that this medication is designed to target?

"Exercise is commonly treated with this medication. This medication can also be effective in treating other conditions including type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Is this study actively searching for new participants?

"This study is no longer looking for additional participants. The trial was first posted on August 26th, 2021 and last updated on January 4th, 2022. However, there are 1283 other trials currently looking for patients with monogenic diabetes and 190 trials for this particular treatment that are enrolling patients."

Answered by AI

Are there other instances where this proposed course of treatment has been studied?

"At the moment, there are a total of 190 clinical trials researching this intervention. Out of those, 48 are in Phase 3. The majority of the trials are based in Rockville, Maryland, but there are 1699 research sites in total."

Answered by AI

What is the total enrollment for this trial?

"Unfortunately, this particular study is not looking for new candidates at this moment. The posting for this trial was made on August 26th, 2021 and the listing was updated on January 4th, 2022. If you are interested in other studies, there are 1283 trials for monogenic diabetes and 190 trials for this treatment that are currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study

2021. "Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04409795.

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