Jentadueto

Metabolic· 936 cited findings· 1 source document

Company: Boehringer Ingelheim

What the regulatory reviews say

Jentadueto is a fixed-dose combination drug containing linagliptin and metformin. The European Medicines Agency (EMA) granted a positive opinion for marketing authorization on May 24, 2012, following an application submitted on June 29, 2011. The product was not licensed in any country at the time of submission.

Clinical trials demonstrated that linagliptin 5 mg over 28 days, compared to placebo, reduced weighted mean daily glucose by -19.9 mg/dL and fasting plasma glucose by -10.8 mg/dL. It also led to a -0.48% decrease in HbA1c over 4 weeks compared to placebo. Linagliptin increased active GLP-1 concentration by 18.1 pmol*h/L and showed greater than 80% DPP-4 inhibition at steady-state with 5 mg or 10 mg once daily doses. Metformin, a component of Jentadueto, was associated with a 10% decrease in total cholesterol levels. Linagliptin exposure increased by 19.8% when combined with metformin.

Safety findings included a rescue therapy rate of 7.9% and 14.1% in different studies. Discontinuation rates for linagliptin were 5.4%. Weight change from baseline was observed as 2.3 kg and 1.2 kg in different groups, with a treatment difference of 1.10 kg. QTcI interval changes were -1.1 ms for 5 mg linagliptin and -2.5 ms for 100 mg linagliptin compared to placebo.

Key figures — cited to the source page

HbA1c decrease (linagliptin vs placebo, 4 weeks)	-0.48	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.66
Weighted mean daily glucose reduction (5 mg linagliptin over 28 days vs placebo)	-19.9	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.65
Fasting plasma glucose reduction (5 mg linagliptin over 28 days vs placebo)	-10.8	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.65
Linagliptin DPP-4 inhibition at steady-state (5 mg or 10 mg once daily)	>80	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.64
Total cholesterol (TC) levels decrease (metformin)	10	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.67
Rescue therapy rate	7.9	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.77
Discontinuation rate (linagliptin)	5.4	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.79
CHMP positive opinion date	24 May 2012	Boehringer Ingelheim — Jentadueto EMA EPAR public assessment, p.6

Source documents

Boehringer Ingelheim — Jentadueto EMA EPAR public assessment report (EMEA/H/C/002279, 2012) (2012)

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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.