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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 54 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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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.
Select...
I have been on a stable dose of metformin (≥1500 mg/day) for at least 8 weeks, with or without insulin.

Timeline

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

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

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
Insulin
2000
Completed Phase 4
~4280
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,562 Previous Clinical Trials
10,906,826 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,670 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,869 Previous Clinical Trials
5,051,759 Total Patients Enrolled

Media Library

Insulin Clinical Trial Eligibility Overview. Trial Name: NCT04029480 — Phase 3
Type 2 Diabetes Research Study Groups: Ertugliflozin pidolate 5 mg/5 mg, Ertugliflozin pidolate 5 mg/15 mg, Placebo
Type 2 Diabetes Clinical Trial 2023: Insulin Highlights & Side Effects. Trial Name: NCT04029480 — Phase 3
Insulin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04029480 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04029480 — Phase 3

Frequently Asked Questions

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

What are the goals that this clinical trial is looking to achieve?

"The purpose of this medical intervention, which will be evaluated over the course of 24 weeks, is to change the levels of Hemoglobin A1C in patients. This study also seeks to understand changes in fasting plasma glucose (FPG) and hemoglobin A1c levels over time between those taking ertugliflozin and a placebo group."

Answered by AI

Does this research on Insulin build off of other scientific work?

"University of Rome La Sapienza first started studying insulin in 2002. Since then, there have been a total of 19730 clinical trials completed on the topic with 264 more currently active. A large portion of these ongoing studies are based out of Los Angeles, California."

Answered by AI

When was Insulin given the green light by the FDA?

"Insulin has been shown to be effective in Phase 3 trials and has received multiple rounds of support for its safety, so it is estimated to be a safe medication."

Answered by AI

Is this research project still looking for participants?

"This medical trial is currently looking for participants, as indicated on clinicaltrials.gov. The listing was originally posted on October 8th, 2019 and was last updated on November 4th, 2020."

Answered by AI

What medical condition is Insulin routinely given to treat?

"Insulin can help people manage their blood sugar levels after physical activity. It is also used as a treatment for type 1 diabetes mellitus, diabetic ketoacidosis, and diabetes mellitus."

Answered by AI

If a patient is 35 years old or younger, do they qualify for this research study?

"This trial is meant for patients aged 10 to 17. Out of the 2,229 clinical trials involving minors, this one falls under the category of 1,364 studies testing treatments on elderly patients."

Answered by AI

Does this trial have a presence in more than one hospital within the city limits?

"Children's Hospital - Los Angeles (Site 2201), Barry J. Reiner MD LLC (Site 2204), and London Health Sciences Centre ( Site 0002) are three of the six medical facilities currently running this trial. The other locations are also in 6 different cities."

Answered by AI

How many research participants are being enrolled in this clinical trial?

"Yes, the trial is still open and looking for patients. According to the website, this study was first posted on October 8th, 2019 and was last updated November 4th, 2020. They are enrolling 150 people in total from 6 different locations."

Answered by AI

Who meets the qualifications to take part in this experiment?

"This study is only recruiting 150 participants, all of whom must be 10-17 years old and have a diagnosis of type 2 diabetes mellitus."

Answered by AI

Who else is applying?

What state do they live in?
California
Michigan
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
William Beaumont Hospital ( Site 2219)
The Children's Hospital of Philadelphia ( Site 2205)
How many prior treatments have patients received?
3+
2

Why did patients apply to this trial?

I’m trying to get my A1c stable. Want to try some different and to help me.
PatientReceived 1 prior treatment
~33 spots leftby Jul 2025