In the recently completed 12 week Phase IIb clinical trial in 494 patients with type 2 diabetes mellitus (T2DM), ‘Melogliptin’, Glenmark’s investigational medicine from a new class of diabetes treatments called dipeptidyl peptidase 4 (DPP-4) inhibitors, improved glycemic control in patients with type 2 diabetes mellitus and exhibited excellent safety and tolerability profile. In addition, patients taking Melogliptin experienced low incidence of hypoglycemia and neutral effect on body weight.
In this 12-week, randomized, double-blind, placebo-controlled, parallel group study, Melogliptin significantly reduced HbA1c from baseline as compared to placebo with a mean average reduction of 0.75% in patients receiving 50mg twice daily dose (p<0001) and 0.60 % in patients receiving 100 mg once daily dose (p<.0001).
In a subgroup of patients with higher baseline HbA1c of 8.5%-10%, Melogliptin reduced HbA1c from baseline as compared to placebo with a mean average reduction of 0.88 % and 1.05 % in patients receiving 100mg once daily dose and 50mg twice daily dose respectively, which compares favorably to reported results of other DPP-4’s.
The Phase IIb results for Melogliptin demonstrate potential for offering class leading improvements in glycemic control and metabolic function. Glenmark recently received IND approval from the USFDA to carry out a clinical study in the US. Glenmark continues to be in discussions with various licensing partners to take the molecule forward.
“Global Phase III trials have been planned with Melogliptin and are due to start at the end of 2009 following regulatory approvals. These studies are designed to evaluate the compound both as monotherapy and in combination with other anti-diabetic therapies in patients with type 2 diabetes mellitus”. said Mr. Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Limited. He further added “With this phase II study being successful, we take a step closer towards our objective of becoming the first Indian company to have a truly global innovative drug for the world”
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Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. Glenmark is a leading player in drug discovery and is the recipient of the prestigious SCRIP award for the “Best Pharma Company in the World - SME” and the “Best Company in Emerging Markets” for 2008. For more information on GPL, log on to http://www.glenmarkpharma.com/
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