Phase 3
N=166
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT04029480 ↗Enrolled (actual)
166
Serious AEs
2.1%
Results posted
Oct 2025
Primary outcome: Primary: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo) — -0.55; 0.12 A1C Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ertugliflozin 5 mg (Drug); Ertugliflozin 15 mg (Drug); Placebo to ertugliflozin 15 mg (Drug); Placebo to ertugliflozin 5 mg (Drug); Insulin (Biological); Metformin (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo) |
-0.55; 0.12 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24 |
59; 33 | — |
| PRIMARY Number of Participants Who Experienced an AE Up to Week 54 |
71; 42 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24 |
0; 0 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54 |
0; 1 | — |
| SECONDARY Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo) |
-0.42; 0.25 | 0.021 sig |
| SECONDARY Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo) |
-0.54; 0.32 | 0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-20.8; 8.2 | 0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1C at Week 54 |
-0.22; 0.81 | 0.003 sig |
| SECONDARY Change From Baseline in FPG at Week 54 |
-12.1; 21.0 | 0.001 sig |
Summary
This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study was that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.
Eligibility Criteria
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
- Be ≥10 years and ≤17 years of age, when the informed consent is signed
- Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
- Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
- T2DM for ≥2 years, OR T2DM for 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.
- Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
- 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.
- Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
- Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
- Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
- Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
- Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
- Has a history of severe hypoglycemia while on insulin.
Data sourced from ClinicalTrials.gov (NCT04029480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.