Steglujan

Metabolic· 901 cited findings· 1 source document

What the regulatory reviews say

Steglujan is a fixed-dose combination of ertugliflozin and sitagliptin, indicated for the treatment of type 2 diabetes mellitus. Regulatory review documents indicate that the marketing authorisation application was submitted on 1 February 2017, with a CHMP positive opinion issued on 25 January 2018. The drug is available in strengths of 5 mg/100 mg and 15 mg/100 mg, and has a shelf-life of 2 years.

Key efficacy findings from clinical trials, with a primary assessment timepoint of 26 weeks, include a change from baseline in HbA1c of -0.78% to -1.05% and a change from baseline in FPG of -9.30 mg/dL to -36.91 mg/dL. The odds ratio for achieving HbA1c < 7.0% versus placebo was 4.43. Additional efficacy observations included body weight reduction ranging from 5% to 12%, and blood pressure lowering (systolic, diastolic, mean) of 8-10%.

Regarding safety, the overall discontinuation rate ranged from 8.2% to 13%, with discontinuation due to adverse events ranging from 0.4% to 3.2%. The hypoglycemia rate was 5.0%. The incidence of volume depletion in the 75-85 age group (placebo) was 1.5%. Renal-related adverse events in the ACE I/ARB concomitant medication subgroup (ertugliflozin) were 0.9%.

Key figures — cited to the source page

HbA1c change from baseline	-1.05	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.62
FPG change from baseline	-36.91	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.64
Odds Ratio for A1C < 7.0% vs Placebo	4.43	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.73
Body weight loss	12	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.20
Overall discontinuation rate	13	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.60
Discontinuation due to adverse events	3.2	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.60
Hypoglycemia rate	5.0	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.133
CHMP positive opinion date	25 January 2018	Merck & Co., Inc. — Steglujan EMA EPAR public assessment rep, p.8

Source documents

Merck & Co., Inc. — Steglujan EMA EPAR public assessment report (EMEA/H/C/004313, 2018) (2018)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.