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FDA Approved Drugs » 2012
Medical Areas: Endocrinology | Family Medicine
View By:Year | Company | Conditions | Therapeutic Areas | Drug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Eli Lilly
Approval Status: Approved February 2012
Treatment Area: type II diabetes
Jentadueto is a fixed dose combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, plus metformin, which helps to control the amount of glucose in the blood.
Jentadueto is specifically approved as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both
linagliptin and metformin is appropriate.
Jentadueto is supplied as a tablet for oral administration. Jentadueto should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended dose of 2.5 mg linagliptin/1000 mg metformin twice daily. The recommended starting dose is as follows:Subjects not currently treated with metformin: initiate treatment with 2.5 mg linagliptin/500 mg metformin hydrochloride twice dailySubjects already treated with metformin: start with 2.5 mg linagliptin and the current dose of metformin taken at each of the two daily mealsSubjects already treated with linagliptin and metformin: individual components may be switched to Jentadueto containing the same doses of each component.
FDA ApprovalThe FDA approval of Jentadueto was based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of Jentadueto was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects. A 24-week, randomized, double-blind, placebo-controlled factorial study enrolled 791 adults with type 2 diabetes and inadequate glycemic control with diet and exercise who received linagliptin plus metformin concurrently. At the maximum dose (2.5 mg linagliptin/1,000 mg metformin twice-daily) Jentadueto demonstrated placebo-corrected reductions in hemoglobin A(1c) (HbA(1c) levels of up to 1.7% (+0.1% for placebo and -1.6% for Jentadueto).
Adverse events associated with the use of Jentadueto may include, but are not limited to, the following:
Jentadueto is a fixed dose combination of linagliptin plus metformin. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibito. DDP-4 is an enzyme that degrades the incretin hormones glucagon-like-peptide-1 (GLP-1) and glucose-dependent insulinotrophic polypeptide. Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the increase of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Metformin is an antihyperglycemic agent which improves glucose tolerance, lowering both basal and postprandial plasma glucose.
For additional information regarding Jentadueto or type II diabetes, please visit the Jentadueto web page.
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