As a chronic disease which occurs when the body does not properly produce, or use the hormone insulin, type 2 diabetes has become a worldwide problem. Roughly 25.8 million Americans and an estimated 366 million people worldwide have diabetes, according to the CDC and 2011 data from the IDF. Type 2 diabetes accounts for 90-95 percent of all diabetes cases, which creates a global need for effective and safe treatment options until a cure is found. Exciting news was announced regarding a new and efficacious type 2 diabetes drug in 2012-Jentadueto. Comprised of both linagliptin, CAS# 668270-12-0 and metformin hydrochloride, CAS# 1115-70-4, Jentadueto was approved both in the U.S. and Europe to improve glycemic control in adults with type 2 diabetes. The U.S. approved Jentadueto on January 30, 2012, and on July 25, 2012, Boehringer Ingelheim and Eli Lilly and Company announced the receipt of Marketing Authorization from the European Commission for this innovative drug. The combination of linagliptin and metformin hydrochloride has been shown in clinical trials to be an effectual treatment, alongside diet and exercise to control blood sugar levels in adults.
Linagliptin and metformin hydrochloride, or Jentadueto, is not for patients with type 1 diabetes, or for people with diabetic ketoacidosis. The side effects of this two-punch drug combo are surprisingly few. The side effects reported most commonly were diarrhea, a stuffy or runny nose, and a sore throat. Boehringer Ingelheim Pharmaceuticals markets the linagliptin, and metformin hydrochloride medication, and the tablets, which are coined Jentadueto are in the following strengths:
- 2.5 milligrams linagliptin/500 milligrams metformin HCl, to be taken twice a day.
- 2.5 milligrams linagliptin/850 milligrams of metformin HCl, to be taken twice a day.
- 2.5 milligrams linagliptin/1000 milligrams metformin HCl, to be taken twice a day.
This medication combination is a crucial development for many patients with type 2 diabetes, and who are currently at their maximally tolerated dose of metformin alone or metformin and a sulfonylurea. Patients may also take linagliptin and metformin hydrochloride with a sulfonylurea. The single tablet treatment option, which is taken twice a day, is an optimal choice for many patients who need an easy and quick method for following their medical regimen.
The American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) issued a joint statement which said that it may be justified for practitioners to prescribe an initial therapy with a combination of two noninsulin agents or with insulin itself. The aforementioned statement applies to patients with a high baseline hemoglobin A1c (HbA1c or A1C) of greater than or equal to 9.0 percent. Clinical research confirms that this combination therapy is essential and statistically superior to metformin monotherapy. After just 24 weeks of treatment with linagliptin 2.5 milligrams and metformin 1000 milligrams, twice daily, patients displayed a 1.6% A1C reduction. The safety of linagliptin and metformin has been evaluated in an astounding number of patients, over 2,800. This record of both efficacy and safety is a reassurance to both practitioners and patients. Type 2 diabetes expert, Dr. Lance Sloan, MD, of the Texas Institute for Kidney and Endocrine Disorders, touted the approval of the linagliptin and metformin hydrochloride duo as exciting news. He stated, “Most people with type 2 diabetes require more than one medication to help lower their blood sugar, due to the complex nature of type 2 diabetes”, and “The approval of Jentadueto is exciting because it combines two diabetes medications in a single tablet, making it a good option for people who need an additional medication, and for whom both linagliptin and metformin is appropriate.”
With an urgent need to treat the massive numbers of type 2 diabetes cases worldwide, the linagliptin and metformin hydrochloride twosome is set up for future success in the pharmaceutical arena. LGM Pharma provides both linagliptin and metformin hydrochloride for research and development purposes. In addition, LGM Pharma offers the TEVA API metformin hydrochloride, as well as complete support to clients throughout the entire R&D process.
Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.