Merck & Co., Inc. — Steglatro EMA EPAR variation assessment report (EMEA/H/C/004315, 2018)
Merck & Co., Inc. · 2018 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of the Phase 3 clinical study MK-8835-P059/B1521066 for ertugliflozin (Steglatro) in pediatric patients (10-17 years old) with Type 2 Diabetes Mellitus. The study evaluated the safety and efficacy of ertugliflozin (5 mg and 15 mg) against placebo, all on background metformin with or without insulin. Ertugliflozin significantly reduced HbA1c and Fasting Plasma Glucose at Weeks 24 and 54 compared to placebo. The safety profile was generally consistent with adult observations, with comparable overall adverse event rates. While specific attention was given to hypoglycemia, UTIs, genital mycotic infections, and renal-related AEs, no significant safety concerns were raised, although nephrocalcinosis was more frequent in the ertugliflozin group.
Key findings — cited to the page
| Proportion of participants with 1-grade change in nephrocalcinosis (combined ertugliflozin group) | 18.9 % | · p.47 |
| Proportion of participants with 1-grade change in nephrocalcinosis (placebo group) | 9.1 % | · p.47 |
| Procedure number | EMA/PAM/0000307025 | Steglatro · p.1 |
| Study phase | Phase 3 | MK-8835-P059/B1521066 · p.5 |
| Age range of participants | 10 to 17 years | MK-8835-P059/B1521066 · p.5 |
| Number of randomized participants | 166 | MK-8835-P059/B1521066 · p.6 |
| Primary efficacy endpoint | Change from baseline in A1C at Week 24 | MK-8835-P059/B1521066 · p.6 |
| Randomization ratio (ertugliflozin:placebo) | 2:1 | MK-8835-P059/B1521066 · p.6 |
| Primary safety endpoint duration | 24 and 54 weeks | MK-8835-P059/B1521066 · p.6 |
| Inclusion criteria: T2DM duration | ≥ 2 years or <2 years with fasting C-peptide >0.6 ng/mL | MK-8835-P059/B1521066 · p.8 |
| Inclusion criteria: HbA1c range (metformin monotherapy) | ≥6.5% and ≤10.0% % | MK-8835-P059/B1521066 · p.8 |
| CHMP adoption of conclusions date | 2026-01-29 | · p.2 |
Source: Merck & Co., Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →