Glenmark Pharmaceutical has completed successfully phase-IIb trials in 494 patients for its novel molecule Melogliptin for type-2 diabetes and the Global phase-III trial is likely to start by end of 2009. Melogliptin improves glucose control and normal pancreatic function. Melogliptin is likely to be launched in 2013.

Melogliptin, investigation medicine from a new class of diabetes treatments called dipeptidyl peptidase 4 (DPP-4) inhibitors exhibited excellent safety and tolerability profile. In addition, patients taking Melogliptin experienced low incidence of hypoglycemia and neutral effect on body weight. Glenmark has recently received IND approval from the US FDA to carry out a clinical study in the US.

Glenmark continues to be in discussions with various licensing partners to take the molecule forward. 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 per cent in patients receiving 50mg twice daily dose (p<0001) and 0.60 per cent in patients receiving 100 mg once daily dose (p<.0001).

In a subgroup of patients with higher baseline HbA1c of 8.5 per cent-10 per cent, Melogliptin reduced HbA1c from baseline as compared to placebo with a mean average reduction of 0.88 per cent and 1.05 per cent in patients receiving 100mg once daily dose and 50mg twice daily dose respectively, which compares favourably to reported results of other DPP-4's.

Glenn Saldanha, MD and CEO, said, "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. 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"

"Ever since diabetes was first identified, researchers have been looking for oral compounds that can restore normal glycaemic control and abnormal beta cell function in a physiological manner from the diseased state. The results from this Melogliptin study hold great promise, both in the short and long term, for patients with diabetes of all severities," mentions Dr John Efthimiou, chief medical officer, Glenmark.

The global diabetes market is estimated at $24 billion in 2007 and projected to grow to $45 billion by 2018. It will likely be the leading drug class in metabolic and Cardio Vascular market. Oral anti-diabetics will drive the market growth with a projected share of 70 per cent of the total market or $31 billion in value.