Method of treating diabetes
View Patent ↗Methods are provided for treating diabetes, lowering plasma level of HbA1c, glucose plasma levels, total cholesterol plasma level, and/or triglyceride plasma level while increasing HDL cholesterol levels and delaying onset of diabetic retinopathy in a diabetic, pre-diabetic, or non-diabetic mammal while minimizing undesirable side effects.
1. A method of treating diabetes in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of ranolazine, which is named N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide, as a racemic mixture or a pharmaceutically acceptable salt thereof, wherein HbA1c level, as measured after 12 weeks of administration, is reduced in the patient, and wherein the patient is not on insulin.
2. The method of claim 1 , wherein ranolazine is administered as an immediate release formulation.
3. The method of claim 1 , wherein ranolazine is administered as a sustained release formulation.
4. The method of claim 1 , wherein ranolazine is administered in a formulation that has both immediate release and sustained release aspects.
5. The method of claim 3 , wherein the sustained release formulation provides a plasma level of ranolazine between 550 and 7500 ng base/ml over a 24 hour period.
6. The method of claim 5 , wherein the sustained release formulation comprises:
Weight
Ingredient
Range (%)
Ranolazine
75
Microcrystalline cellulose (filler)
10.6
Methacrylic acid copolymer
10.0
Sodium hydroxide
0.4
Hydroxypropyl methylcellulose
2.0
Magnesium stearate
2.0.
7. The method of claim 6 , wherein the sustained release formulation comprises:
Ingredient
Ranolazine Formulation (mg)
Ranolazine
500
Microcrystalline cellulose (filler)
70.7
Methacrylic acid copolymer
66.7
Sodium hydroxide
2.7
Hydroxypropyl methylcellulose
13.3
Magnesium stearate
13.3.
8. The method of claim 1 , wherein the patient is a Type II diabetic patient.
9. The method of claim 1 , wherein the HbA1c level is reduced by at least 0.48 percentage point.