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(12) Patent Application Publication (10) Pub. No.: US 2007/0088012 A1 Seo (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2007/0088012 A1 Seo (43) Pub US 20070O880 12A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0088012 A1 Seo (43) Pub. Date: Apr. 19, 2007 (54) METHOD OF TREATING OR PREVENTING Publication Classification TYPE-2 DABETES (51) Int. Cl. (76) Inventor: Woun Seo, Marietta, GA (US) A 6LX 3/57 (2006.01) A6F 3/02 (2006.01) Correspondence Address: (52) U.S. Cl. ............................................ 514/171; 424/448 MAYER, BROWN, ROWE & MAW LLP P.O. BOX2828 CHICAGO, IL 60690-2828 (US) (57) ABSTRACT (21) Appl. No.: 11/399,642 The present invention is generally related to a method of treating, preventing, or reducing the risk of developing (22) Filed: Apr. 6, 2006 type-2 diabetes, and, more particularly, is related to a method of administering a transdermal hydroalcoholic gel Related U.S. Application Data composition to treat or prevent type-2 diabetes and a method of administering a transdermal hydroalcoholic gel compo (60) Provisional application No. 60/669,606, filed on Apr. sition to increase glycemic control in a Subject in need 8, 2005. thereof. US 2007/0O880 12 A1 Apr. 19, 2007 METHOD OF TREATING OR PREVENTING high-affinity sex hormone binding globulin (“SHBG'). The TYPE-2 DABETES remaining 60% is bound weakly to albumin. Thus, a number of measurements for testosterone are available from clinical 0001. This application claims priority to U.S. provisional laboratories. The term “free’’ testosterone as used herein Application Ser. No. 60/669,606 filed Apr. 8, 2005, the refers to the fraction of testosterone in the blood that is not entire contents of which is hereby incorporated by reference bound to protein. The term “total testosterone' or “testoster herein. one' as used herein means the free testosterone plus protein bound testosterone. The term “bioavailable testosterone” as FIELD OF THE INVENTION used herein refers to the non-SHBG bound testosterone and 0002 The present invention is generally related to a includes testosterone weakly bound to albumin. method of treating, preventing, or reducing the risk of 0007. The following table from the UCLA-Harbor Medi developing type-2 diabetes, and, more particularly, is related cal Center Summarizes the hormone concentrations in nor to a method of administering a transdermal hydroalcoholic mal adult men range: gel composition to treat or prevent type-2 diabetes and a method of administering a transdermal hydroalcoholic gel TABLE 1. composition to increase glycemic control in a subject in need thereof. Hormone Levels in Normal Men Hormone Normal Range BACKGROUND OF THE INVENTION Testosterone 298 to 1043 ng/dL 0003 Type-2 diabetes is a carbohydrate metabolism dis Free testosterone 3.5 to 17.9 mg/dL DHT 31 to 193 ng/dL order thought to be caused by a combination of hereditary DHTT Ratio O.OS2 to 0.33 and environmental factors. Individuals afflicted with type-2 DHT - T 372 to 1349 ng/dL diabetes typically demonstrate inadequate secretion or uti SHBG 10.8 to 46.6 mmol/L lization of insulin, excessive urine production, and excessive FSH 1.0 to 6.9 ml UmL amounts of sugar in the blood and urine. Established risk LH 1.0 to 8.1 ml/mL factors for the development of type-2 diabetes include E. 17.1 to 46.1 pg/mL obesity, an unfavorable body fat distribution, impaired glu cose tolerance, hyperinsulinemia and insulin resistance. 0008. There is considerable variation in the half-life of Insulin resistance, at least initially and often throughout the testosterone reported in the literature, ranging from 10 to patient’s lifetime, fundamentally underlies the pathophysi 100 minutes. Researchers do agree, however, that circulating ology of type-2 diabetes and improving insulin sensitivity is testosterone has a diurnal variation in normal young men. one of the primary therapeutic approaches and provides a Maximum levels occur at approximately 6:00 to 8:00 a.m. valuable assessment of this disease state. Obesity, especially with levels declining throughout the day. Characteristic visceral obesity, and dyslipidemia have been reported to be profiles have a maximum testosterone level of 720 ng/dL associated with most of the type-2 diabetic subjects. They and a minimum level of 430 ng/dL. The physiological are also the risk factors for developing the disease. One of significance of this diurnal cycle, if any, however, is not the treatment goals in diabetes is to prevent chronic com clear. plications, which includes aggressive control of obesity, dyslipidemia and hypertension. 0009 Male hypogonadism results from a variety of patho-physiological conditions in which testosterone con 0004 Males suffering from type-2 diabetes have been centration is diminished below the normal range. The shown to have lower testosterone levels than healthy men. hypogonadic condition is sometimes linked with a number Barrett-Connor, E., et al., Am. J. Epidemiol., 132(5):895-901 of physiological changes, such as diminished interest in sex, (1990). Type-2 diabetes often surfaces during middle-age, at impotence, reduced lean body mass, decreased bone density, the same time as male testosterone levels begin to decrease lowered mood, and decreased energy levels. with age (andropause). Erectile dysfunction is a common complication of type-2 diabetes which often can be an early 0010 Researchers generally classify hypogonadism into symptom and may cause depression. one of three types. Primary hypogonadism includes the testicular failure due to congenital or acquired anorchia, 0005 Testosterone, the major circulating androgen in XYY Syndrome, XX males, Noonan's Syndrome, gonadal men, is synthesized from cholesterol. The approximately dysgenesis, Leydig cell tumors, maldescended testes, vari 500 million Leydig cells in the testes secrete more than 95% cocele, Sertoli-Cell-Only Syndrome, cryptorchidism, bilat of the 6-7 mg of testosterone produced per day. Two eral torsion, vanishing testis syndrome, orchiectomy, hormones produced by the pituitary gland, luteinizing hor Klinefelter's Syndrome, chemotherapy, toxic damage from mone (“LH) and follicle stimulating hormone (“FSH'), are alcohol or heavy metals, and general disease (renal failure, required for the development and maintenance of testicular liver cirrhosis, diabetes, myotonia dystrophica). Patients function and negatively regulate testosterone production. with primary hypogonadism show an intact feedback Circulating testosterone is metabolized to various 17-keto mechanism in that the low serum testosterone concentrations steroids through two different pathways. Testosterone can be are associated with high FSH and LH concentrations. How metabolized to dihydrotestosterone (“DHT) by the enzyme ever, because of testicular or other failures, the high LH 5C.-reductase or to estradiol (“E2) by an aromatase enzyme concentrations are not effective at stimulating testosterone complex. production. 0006 Testosterone circulates in the blood 98% bound to 0011 Secondary hypogonadism involves an idiopathic protein. In men, approximately 40% of the binding is to the gonadotropin or LH-releasing hormone deficiency. This type US 2007/0O880 12 A1 Apr. 19, 2007 of hypogonadism includes Kallman’s Syndrome, Prader DETAILED DESCRIPTION OF THE Labhart-Willis Syndrome, Laurence-Moon-Biedl’s Syn INVENTION drome, pituitary insufficiency/adenomas, Pasqualini’s Syn 0015 While the present invention may be embodied in drome, hemochromatosis, hyperprolactinemia, or pituitary many different forms, several specific embodiments are hypothalamic injury from tumors, trauma, radiation, or discussed herein with the understanding that the present obesity. Because patients with secondary hypogonadism do disclosure is to be considered only as an exemplification of not demonstrate an intact feedback pathway, the lower the principles of the invention, and it is not intended to limit testosterone concentrations are not associated with increased the invention to the embodiments illustrated. Where the LH or FSH levels. Thus, these men have low testosterone invention is illustrated herein with particular reference to serum levels but have gonadotropins in the normal to low testosterone, it will be understood that any other steroid in range. the testosterone synthetic pathway can, if desired, be Sub stituted in whole or in part for testosterone in the methods, 0012. Third, hypogonadism may be age-related. Men kits, combinations, and compositions herein described. experience a slow but continuous decline in average serum 0016. The present invention relates to a method of admin testosterone after approximately age 20 to 30 years. istering a transdermal hydroalcoholic gel composition to Researchers estimate that the decline is about 1-2% per year. treat, prevent, or reduce the risk of developing type-2 Cross-sectional studies in men have found that the mean diabetes. The present invention also relates to a method of testosterone value at age 80 years is approximately 75% of administering a transdermal hydroalcoholic gel composition that at age 30 years. Because the serum concentration of to increase glycemic control in a Subject in need thereof. The SHBG increases as men age, the fall in bioavailable and free present application also relates to the use of this transdermal testosterone is even greater than the fall in total testosterone. hydroalcoholic gel composition in the manufacture of a Researchers have estimated that approximately 50% of percutaneously deliverable medicament for treating, pre healthy men between the ages of 50 and 70 have levels of venting or reducing the risk of developing type-2 diabetes bioavailable
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