Combination of substances for regenerative therapy in patients with type 1 diabetes mellitus

Abstract

This invention applies to the field of medicine, namely to endocrinology, and intended for the treatment of type 1 diabetes mellitus.The invention proposes a combination, containing a Dipeptidyl peptidase-4 (DPP-4) inhibitors, a proton pump inhibitors (PPI), and gamma-aminobutyric acid or a gamma-aminobutyric acid receptor agonists. This unique combination of medications and specific dosage of drugs leads to the regeneration (recovery) of the β-cells of the pancreas, which is presented by a dramatic reduction of insulin requirements up to a total insulin discontinuation in some persons.

1 . A medication for treating patients with type 1 diabetes mellitus, comprising a single dose form consisting essentially of therapeutically effective amounts of: dipeptidyl peptidase (DPP-4) inhibitor, proton pump inhibitor (PPI) and gamma-aminobutyric acid preparation (GABA) or GABA receptor agonist, in powder, granule, tablet or microcapsule suspension form for oral administration. 
     
     
         2 . The medication of  claim 1 , wherein the amount of DPP-4 inhibitor is between 25-100 mg, the amount of PPI is between 10-40 mg, and the amount of GABA or GABA receptor agonist is between 125-1500 mg. 
     
     
         3 . The medication form of  claim 1 , wherein the DPP-4 inhibitor is sitagliptin and the PPI is omeprazole. 
     
     
         4 . A kit for daily oral administration, for treating patients with type 1 diabetes mellitus, the kit comprising therapeutically effective amounts of:
 a first composition comprising dipeptidyl peptidase (DPP-4) inhibitor;   a second composition comprising proton pump inhibitor (PPI); and   a third composition comprising gamma-aminobutyric acid preparation (GABA) or GABA receptor agonist.   
     
     
         5 . The kit of  claim 4 , wherein:
 the first composition comprises a dose of between 25-100 mg/day of DPP-4 inhibitor;   the second composition comprises a dose of between 10-40 mg/day of PPI; and   the third composition comprises a dose of between 125-1500 mg/day of GABA.   
     
     
         6 . The kit of  claim 4 , wherein the DPP-4 inhibitor is sitagliptin and the PPI is omeprazole.