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Ertugliflozin for Pediatric Type 2 Diabetes

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

T2DM for ≥2 years, OR T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL at Screening.

On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.

Must not have

Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.

Has known monogenic diabetes, or secondary diabetes.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 54 weeks

Awards & highlights

Pivotal Trial

Summary

This trial will study whether ertugliflozin is safe and effective in children with Type 2 Diabetes who are already taking metformin and/or insulin. The goal is to see if ertugliflozin can help lower HbA1C levels more than placebo after 24 weeks.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions seen with SGLT2 inhibitors like urinary tract infections due to increased sugar in urine, dehydration risks because these drugs make you pee more often, and possible genital yeast infections.

Eligibility Criteria

Inclusion Criteria

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

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

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

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My BMI is in the top 85% or I was overweight when diagnosed with Type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have type 1 diabetes or tested positive for diabetes autoantibodies.

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

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

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

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I have a history of unexplained or chronic pancreatitis.

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I have had severe low blood sugar episodes while using insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 54 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 54 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 weeks 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 from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin pidolate 5 mg and 15 mg versus placebo)

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experience an AE

+1 more

Secondary study objectives

Change from Baseline in FPG at 54 Weeks

Change from Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks

Change from Baseline in Hemoglobin A1C at 54 Weeks

+2 more

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Ertugliflozin pidolate 5 mg/5 mgExperimental Treatment4 Interventions

All participants will initially receive ertugliflozin pidolate (ERTU) 5 mg once daily (QD) and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at Week 12 (WK12), all participants that do not meet the up-titration criteria will remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54. Approximately half the participants who meet the up-titration criteria at the second randomization at WK12 will also remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54. Note: For participants not on insulin, the up-titration criterion at the second randomization at WK12 is HbA1C ≥7.0% (53 mmol/mol) and for participants on insulin, a fasting fingerstick glucose (FFSG) of ≥110 mg/dL (6.1 mmol/L) will be required in addition to HbA1C ≥7.0% (53 mmol/mol). Participants will remain on their background metformin with/without insulin treatment throughout the study.

Group II: Ertugliflozin pidolate 5 mg/15 mgExperimental Treatment6 Interventions

All participants will initially receive ERTU 5 mg QD and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at WK12, approximately half the participants who meet the up-titration criteria at the second randomization will up-titrate to ERTU 15 mg and placebo to ERTU 5 mg from WK12 to WK54. Note: For participants not on insulin, the up-titration criterion at the second randomization at WK12 is HbA1C ≥7.0% (53 mmol/mol) and for participants on insulin, a FFSG of ≥110 mg/dL (6.1 mmol/L) will be required in addition to HbA1C ≥7.0% (53 mmol/mol). Participants will remain on their background metformin with/without insulin treatment throughout the study.

Group III: PlaceboPlacebo Group2 Interventions

At the first randomization, participants receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD for 12 weeks. Participants in the placebo group with HbA1C ≥7.0% (53 mmol/mol) at WK12 will be mock titrated. Note: The up-titration criteria for participants on insulin will include a FFSG of ≥110 mg/dL (6.1 mmol/L) in addition to HbA1C ≥7.0% (53 mmol/mol) at WK12. Participants will continue to receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD from WK24 to WK54. Participants will remain on their background metformin with/without insulin treatment throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

Insulin

2000

Completed Phase 4

~4280