These drugs may hit the market in the near future as potential treatments for diabetes. [Celso Pupo - Fotolia.com]
LY2963016
Sponsor/Developer: Eli Lilly and Boehringer Ingelheim
Mechanism of action: Basal insulin analog
Indication (Phase): Type 1 diabetes, compared with Lantus and Insulin Lispro (Phase III; ELEMENT I study ongoing but not recruiting as of August 2012); Type 2 diabetes, compared with Lantus and oral antihyperglycemic medications (Phase III; ELEMENT II study completed as of September 2012); Comparison to Lantus, healthy participants (Phase I, completed September 2012); Comparison to Lantus after single dose for healthy subjects (Phase I, recruiting as of September 2012); Type 1 diabetes, comparison to Lantus (Phase I, completed July 2012); Comparison to Lantus, pharmacokinetics and pharmacodynamics (Phase I, completed July 2012); Comparison to Lantus after single dose for healthy subjects (Phase I, completed 2011)
Metreleptin
Sponsor/Developer: Bristol-Myers Squibb; Developed by Amilyn Pharmaceuticals, acquired by BMS in a $7 billion deal completed Aug. 8
Mechanism of action: Leptin analog
Indication (Phase): Diabetes and/or hypertriglyceridemia in patients with rare forms of lipodystrophy (Registration; BLA submitted April 2012; Fast Track designation)
MK-3102
Sponsor/Developer: Merck & Co.
Mechanism of action: DPP-4 inhibitor
Indication (Phase): Once-weekly for adults with type 2 diabetes: Comparison with Sitagliptin in Japanese participants with type 2 diabetes (Phase III; recruiting as of November 2012); Comparison with chronic kidney disease or kidney failure on dialysis (Phase III; recruiting as of November 2012); Add-on to oral antihyperglycemic agent study in Japanese participants with type 2 diabetes (Phase III; recruiting as of November 2012); Compared with glimepiride in participants with type 2 diabetes who have inadequate glycemic control on metformin (Phase III; recruiting as of November 2012); Adults with type 2 diabetes and inadequate glycemic control following combination therapy of glimepiride and metformin (Phase III; recruiting as of November 2012); Phase IIb results announced in October 2012
Nucynta® ER (tapentadol)
Sponsor/Developer: Johnson & Johnson and Grunenthal
Mechanism of action: Centrally-acting synthetic analgesic; agonist of the μ-opioid receptor and as a norepinephrine reuptake inhibitor
Indication (Phase): Approved August 2012 for diabetic peripheral neuropathy (extended release formulation)
Ranolazine
Sponsor/Developer: Gilead
Mechanism of action: Late sodium current inhibitor
Indication (Phase): Type 2 diabetes (Phase III)
RG1439 (aleglitazar)
Sponsor/Developer: Roche
Mechanism of action: Dual peroxisome proliferator-activated receptor (PPAR) α/γ activation
Indication (Phase): Cardiovascular risk reduction in type 2 diabetes (Phase III; NDA filing expected 2015)
Ryzodeg® (insulin degludec + insulin aspart)
Sponsor/Developer: Novo Nordisk
Mechanism of action: Soluble fixed combination of basal insulin with bolus insulin aspart
Indication (Phase): U.S.—Once daily for type 1 and type 2 diabetes (Registration; NDA submitted September 2011; recommended for approval Nov. 9 by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, with commitment to a post-approval cardiovascular outcomes trial)
EU—Type 1 and type 2 diabetes (Registration; MAA submitted September 2011; recommended for approval Oct. 18 by CHMP)
Semaglutide (NN9535)
Sponsor/Developer: Novo Nordisk
Mechanism of action: GLP-1 analog
Indication (Phase): Once-weekly for type 2 diabetes (Phase III; SUSTAIN™ study, set to start first half of 2013)
Starsis (nateglinide)
Sponsor/Developer: Ajinomoto and Astellas
Mechanism of action: Insulin secretion enhancer
Indication (Phase): Japan—Type 2 diabetes, with DPP-4 inhibitors (Phase III; new indication)
TAK-875
Sponsor/Developer: Takeda
Mechanism of action: G-protein-coupled receptor (GPR) 40 agonist
Indication (Phase): Asia-Pacific adults with type 2 diabetes (Phase III; GRAND-307 study, recruiting as of November 2012); Diabetic patients, compared with Glimepiride (Phase III; recruiting as of November 2012); Adults with type 2 diabetes, with metformin, compared with Glimepiride (Phase III; GRAND-305 study, recruiting as of August 2012); Adults with type 2 diabetes (Phase III; recruiting as of August 2012); Adults with type 2 diabetes, compared to placebo and sitagliptin with metformin (Phase III; recruiting as of August 2012); Adults with type 2 diabetes and cardiovascular disease (Phase III; recruiting as of August 2012)
Tofogliflozin hydrate (CSG452)
Sponsor/Developer: Roche and Chugai Pharmaceutical
Mechanism of action: SGLT2 inhibitor
Indication (Phase): Oral treatment for type 2 diabetes (Phase III)
Trelagliptin succinate (SYR-472)
Sponsor/Developer: Takeda Pharmaceuticals and Furiex Pharmaceuticals
Mechanism of action: DPP-4 inhibitor
Indication (Phase): Japan—Once-weekly oral treatment for type 2 diabetes (Phase III; study expected to be completed in second half of 2013)
Tresiba® (Insulin degludec)
Sponsor/Developer: Novo Nordisk
Mechanism of action: Once-daily basal insulin
Indication (Phase): U.S.—Type 1 and type 2 diabetes (Registration; NDA submitted September 2011; recommended for approval Nov. 9 by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, with commitment to a post-approval cardiovascular outcomes trial)
EU—Type 1 and type 2 diabetes (Registration; MAA submitted September 2011; recommended for approval Oct. 18 by CHMP in 100 units/mL and 200 units/mL formulations, the latter would be the first insulin in Europe to be marketed at a higher strength than 100 units/mL)
Japan—Approved September 2012 for type 1 and type 2 diabetes