Ertugliflozin for Pediatric Type 2 Diabetes

No longer recruiting at 142 trial locations

Overseen By Toll Free Number

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Metformin, Insulin

Must not be taking: SGLT2 inhibitors

Disqualifiers: Type 1 diabetes, Monogenic diabetes, Pancreatitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 54 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called ertugliflozin for children and teens with type 2 diabetes who already take metformin, with or without insulin. The goal is to determine if adding ertugliflozin can lower blood sugar levels more effectively than a placebo after 24 weeks. Those with type 2 diabetes for at least two years and on a consistent dose of metformin might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

You can continue taking your current medications, like metformin and insulin, as the trial includes participants already on these treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ertugliflozin, the treatment being tested in this study, is generally safe for adults with type 2 diabetes. However, there is insufficient information about its safety for children and teenagers with the same condition. Some studies suggest that drugs like ertugliflozin can help control blood sugar levels in young people, but their complete safety for children remains unknown.

In adults, ertugliflozin has been linked to risks such as ketoacidosis, a serious condition where the body produces too much acid. Anyone considering joining the trial should discuss these potential risks and benefits with their doctor. The trial aims to learn more about how well young people can handle ertugliflozin, highlighting the study's importance. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for type 2 diabetes?

Ertugliflozin is unique because it offers a new approach to managing pediatric type 2 diabetes by targeting the kidneys to help remove excess glucose from the body. Unlike standard treatments such as metformin and insulin, which focus on improving insulin sensitivity or providing insulin directly, ertugliflozin works as an SGLT2 inhibitor. This means it blocks a protein involved in glucose reabsorption in the kidneys, allowing more sugar to be excreted in urine. Researchers are excited about this treatment because it could offer a complementary mechanism to existing therapies, potentially improving blood sugar control and providing a new option for young patients.

What evidence suggests that ertugliflozin might be an effective treatment for pediatric type 2 diabetes?

Research shows that ertugliflozin, an SGLT2 inhibitor, can help control blood sugar levels in people with type 2 diabetes. Studies have found that these medications work well for children and young adults with this condition. In this trial, participants will receive either ertugliflozin or a placebo, alongside their background metformin with or without insulin treatment. Ertugliflozin helps the body remove extra sugar through urine, which can lower blood sugar levels. Early results suggest that adding ertugliflozin to treatments like metformin or insulin may further reduce hemoglobin A1C, a measure of long-term blood sugar, in young patients. This could lead to better overall blood sugar control. ^{4 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for children with Type 2 diabetes who are overweight or have been diagnosed for at least 2 years. They must be on a stable dose of metformin, possibly with insulin, and agree to use contraception if sexually active. It's not for those with Type 1 diabetes, known sensitivity to SGLT2 inhibitors, severe hypoglycemia history on insulin, pregnant or breastfeeding females, or anyone needing immediate hyperglycemia treatment.

Inclusion Criteria

I have had type 2 diabetes for 2 or more years, or if less, my C-peptide level is above 0.6 ng/mL.

I have been on a stable dose of metformin (≥1500 mg/day) for at least 8 weeks, with or without insulin.

Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

I have a genetic form of diabetes or diabetes caused by another condition.

I have taken medication like canagliflozin or been in a study for it.

I need immediate treatment for high blood sugar or ketones in my urine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ertugliflozin or placebo for 54 weeks, with a primary focus on reducing HbA1C levels

54 weeks

Regular visits for monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ertugliflozin
• Insulin
• Metformin
• Placebo

Trial Overview The study tests whether adding Ertugliflozin (5 mg or 15 mg) to the current treatment of metformin with/without insulin in kids helps control blood sugar better than a placebo after six months. The main goal is seeing if it lowers hemoglobin A1C levels more effectively.

How Is the Trial Designed?

Group I: Ertugliflozin 5 mg/5 mg Experimental Treatment 4 Interventions

All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.

Group II: Ertugliflozin 5 mg/15 mg Experimental Treatment 6 Interventions

All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.

Group III: Ertugliflozin 5 mg Experimental Treatment 4 Interventions

All participants initially received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.

Group IV: Placebo Placebo Group 4 Interventions

All participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Insulin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Insulin for:

• Diabetes mellitus

Approved in United States as Insulin for:

• Diabetes mellitus

Approved in Canada as Insulin for:

• Diabetes mellitus

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/62433?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric S... This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017006/

Efficacy and Safety of SGLT2 Inhibitors in Pediatric Patients ... Conclusion: In children, adolescents, and young adults with T2DM, SGLT2i appears to be effective and safe for glycemic control. 1. Introduction.

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-ertugliflozin-for-children-and-teens-with-type-2-diabetes/

Study on Ertugliflozin for Children and Teens with Type 2 ... The purpose of the study is to evaluate the safety and effectiveness of ertugliflozin in managing blood sugar levels in young people with Type 2 ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/2024/6295345

Efficacy and Safety of SGLT2 Inhibitors in Pediatric Patients ... Conclusion: In children, adolescents, and young adults with T2DM, SGLT2i appears to be effective and safe for glycemic control. 1. Introduction.

5. withpower.com withpower.com/trial/phase-3-diabetes-mellitus-9-2019-16cc6

Ertugliflozin for Pediatric Type 2 Diabetes This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/209803s008lbledt.pdf

STEGLATRO® (ertugliflozin) tablets, for oral use There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors. Precipitating conditions ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/ertugliflozin-oral-route/description/drg-20406661

Ertugliflozin (oral route) - Side effects & dosage Appropriate studies have not been performed on the relationship of age to the effects of ertugliflozin in the pediatric population. Safety and efficacy have not ...

8. ec.europa.eu ec.europa.eu/health/documents/community-register/2019/20190402144021/anx_144021_en.pdf

STEGLATRO, INN-ertugliflozin The safety and efficacy of ertugliflozin in patients with type 1 diabetes have not been established and ertugliflozin should not be used for treatment of ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf

4197746 This label may not be the latest approved by FDA ... The safety and efficacy of STEGLATRO have not been established in patients with type 2 diabetes ... It is not known if STEGLATRO is safe and effective in children ...