Drugs / Linagliptin/Metformin
last change Jan 2020 re-read 9 days ago

Linagliptin/Metformin

Investigated by
Boehringer Ingelheim · Eli Lilly and Company

Trials 1

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT01845077 May → Aug 2013 — Boehringer Ingelheim Completed No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2020-01-27 Eli Lilly and Company Regulatory US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise.
2014-08-04 Eli Lilly and Company Regulatory Type 2 diabetes: Jentadueto® (linagliptin and metformin hydrochloride) tablets label updated to include new data on blood glucose reductions in treatment-naive adults with high baseline A1C lilly.com ↗
The U.S. Prescribing Information for Jentadueto® (linagliptin and metformin hydrochloride) tablets now includes clinical trial data that showed linagliptin co-administered with metformin provided statistically significant decreases in blood glucose compared with linagliptin alone in treatment-naive* adults with type 2 diabetes and high baseline A1C levels (A1C of &#62 /=8.5 to &#60 /=12.0 percent).
2014-06-09 Eli Lilly and Company Results Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 43 Presentations at the 74th American Diabetes Association Scientific Sessions® lilly.com ↗
Oral glucose lowering with linagliptin plus metformin is a viable initial treatment strategy in patients with newly diagnosed type 2 diabetes (T2D) and marked hyperglycemia
2012-07-25 Eli Lilly and Company Regulatory Jentadueto® (linagliptin/metformin hydrochloride) tablets receive approval for the treatment of adults with type 2 diabetes in Europe lilly.com ↗
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced the receipt of Marketing Authorization from the European Commission for Jentadueto® (linagliptin/metformin hydrochloride) tablets, a medicine combining the DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta® tablets, marketed under the trade name Trajenta® in Europe) and metformin in a single tablet taken twice daily.
2012-05-29 Eli Lilly and Company Regulatory Jentadueto® (linagliptin/metformin hydrochloride) tablets recommended for approval in the treatment of adults with type 2 diabetes in Europe lilly.com ↗
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of JENTADUETO for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin.
2012-01-30 Eli Lilly and Company Regulatory FDA approves Jentadueto™ (linagliptin/metformin hydrochloride) tablets for the treatment of adult patients with type 2 diabetes lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto™ (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin.

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Linagliptin/Metformin “Relative Bioavailability of Two Newly Developed Extended Release FDC Tablet Strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin Extended Release Compared With the...” NCT01845077 ↗