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WO2006033568A1 - Composition synergique pour le traitement du diabete et de ses comorbidites - Google Patents

Composition synergique pour le traitement du diabete et de ses comorbidites Download PDF

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Publication number
WO2006033568A1
WO2006033568A1 PCT/MX2005/000057 MX2005000057W WO2006033568A1 WO 2006033568 A1 WO2006033568 A1 WO 2006033568A1 MX 2005000057 W MX2005000057 W MX 2005000057W WO 2006033568 A1 WO2006033568 A1 WO 2006033568A1
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Prior art keywords
diabetes
treatment
metformin
pioglitazone
glimepiride
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English (en)
Spanish (es)
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Jorge Luis Rosado Loria
Miguel Ángel DUARTE VÁSQUEZ
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • the present invention is related to the pharmaceutical industry in general and to the manufacturing industry of pharmaceutical products for the treatment of diabetes and its co-morbidities.
  • Diabetes mellitus is a metabolic disorder characterized by hyperglycemia, insulin resistance and is often associated with other disorders such as obesity hypertension, hyperlipidemia, as well as cardiovascular complications, retinopathy, neuropathy and nephropathy.
  • Type 2 diabetes mellitus is by far the most common form of diabetes, contributing 80-90% of diagnosed patients. This disease occurs when the body does not produce enough of a hormone called insulin, or when the body cannot use insulin properly.
  • Insulin resistance helps to have a good balance of blood glucose levels.
  • the treatment of DM2 is based on lifestyle management and cardiovascular risk improvement. Sometimes the diet and exercise are not sufficient to maintain adequate glycemic control, making it necessary to use other types of treatments such as medications or insulin injections.
  • the first reference line of drugs to be applied is a treatment with metformin for obese patients or with glibenclamide for other types of patients. If monotherapy fails to control glucose, the combination of medications is recommended to improve glycemic control.
  • a combination therapy was developed for the treatment of DM and to improve glycemic control.
  • Said therapy consists of the combination of a hypoglycemic agent belonging to the family of the new generation sulfonylurea, specifically the glimepiride with an antihyperglycemic agent belonging to the benzothiazolidinediones or glitazone family, specifically the pioglitazone.
  • Sulfonylureas They have an acute hypoglycemic effect, stimulates insulin secretion by binding to the beta cells of the pancreas and a chronic hypoglycemic effect that is due to the potentiation of the action of insulin through an increase in the number of receptors for Ia insulin in the tissues sensitive to it (Lief et al. Sulfonylureas in NIDDM. Diabetes care (1992); 15: 737-754.)
  • Biguanides Its antihyperglycemic effect is through extrapancreatic actions, especially due to the decrease in hepatic glucose secretion. They act fundamentally at two levels: in the muscle increasing the entry of glucose into the cell and in the liver decreasing the production of glucose by decreasing gluconeogenesis and glycogenolysis or both. It also has an anorexigenic effect contributing to weight loss in obese people (Rojas E. Biguanidas, antidiabetics and lactic acidosis. Rev. Clin. Esp. 1997; 8: 568-573.).
  • Alpha-like inhibitors GI: They act by inhibiting intestinal alpha-glycosidases present in intestinal villi.
  • Thiazolidinediones are also insulin-sensitizing drugs, they act at the muscular and hepatic level, reducing insulin resistance and to a lesser extent decreasing hepatic glucose production (Bell D. Prudent utilization of the presently avaliable treatment modalities for Type 2 Diabetes The
  • Meglitidines They act by stimulating insulin secretion at the level of pancreatic beta cells, although with a beta cell binding profile different from sulfonylureas.
  • Insulins and analogues of insulin should always be used in the treatment of type 1 DM and in an important number in DM2.
  • an insulin analogue called Lispro was developed, in which a change in the amino acid order of the B chain has been introduced. The change in The primary structure of this insulin analogue prevents dimerization by which an almost immediate onset of action is achieved.
  • Sulfonylurea-metformin The most commonly used combination therapy is metformin-sulfonylurea. These two agents have complementary mechanisms of action, which allows them to have a synergistic effect.
  • Blonde et al. (Blonde et al. Glyburide / metformin combination product ⁇ s safe and efficacious in patients with type 2 diabetes failing sulphonylurea therapy. Diabetes Obesity and Metabolism. 2002; 4: 368-375) developed a sulfonylurea-metformin combination therapy, using glyburide as sulfonylurea, which reduced the levels of glycosylated hemoglobin (HbAIc) by 1.7% more than monotherapy with any of the agents.
  • HbAIc glycosylated hemoglobin
  • Marre et al (Marre et al. Improved glycaemic control with metformin-glibenclamide combined tablet therapy (Glucovance®) in type 2 diabetic patients inadequately controlled on metformin.
  • Glucovance® metformin-glibenclamide combined tablet therapy
  • Diabetic Medicine 2002; 19: 673-680 used a combination therapy with sulfonylurea-metformin, the sulfonylurea used was glibenclamide. With this therapy, decreases in HbAIc of 1.2% were achieved, while with metformin and glibenclamide each one separately, decreases of 0.19 and 0.23% respectively were obtained.
  • Charpentier et al (Charpentier et al. Improved glycaemic control by addition of glimepiride to metfromin monotherapy in type 2 diabetic patients. Diabetic Medicine. 2001; 18: 828-834.) Obtained reductions in HbAIc levels of 0.74% in a combination therapy Glimepiride-metformin, these reductions were statistically different than those obtained with monotherapy.
  • the GIs are normally pseudo-polysaccharides of bacterial origin, which bind competitively to the alpha glucosidase at the edge of the small intestine by decreasing or delaying the absorption of glucose.
  • Two are the most commonly used medications of this type, miglitol and acarbose. They are effective in monotherapy and in combination with sulfonylureas and metformin.
  • Chiason and Naditch (Chiasson JL., Naditch L. The synergistic effect of miglitol plus metformin combination therapy in the treatment of type 2 diabetes. Diabetes Care. 2001; 24: 989-2001) studied the efficacy and safety of the use of miglitol in combination with metformin in the improvement of glycemic control in patients with type 2 diabetes insufficiently controlled with the diet. 324 patients with type 2 diabetes were studied and assigned to each of the following groups: placebo, miglitol, metformin, miglitol / metformin, for 36 weeks. 100 mg three times a day of miglitol and 500 mg three times a day of metformin were administered. The main criterion to evaluate the efficacy was the change in HbAIc of the baseline at the end of the treatment.
  • Van Gaal et al (Van Gaal et al. Miglitol combined with metformin improves glycaemic control ⁇ n type 2 diabetes. Diabetes, Obesity and Metabolism. 2001; 3: 326-331) investigated the efficacy and safety of using miglitol in patients with type 2 diabetes insufficiently controlled with metformin and diet. Patients treated with diet and metformin (1500-2250 mg / day) were randomly assigned to additional treatment with miglitol or placebo for 32 weeks.
  • the main efficiency criterion was the change in glycosylated hemoglobin (HbAIc). There was a significant decrease in
  • the main disadvantages of the combination therapy IG-metformin are related to the adverse effects they produce.
  • the side effects of both agents are mainly of the gastrointestinal type, therefore, combining both agents enhances their adverse effects.
  • Meglitinides are derivatives of the amino acid D-fen i lalan ina, which act directly on the beta cells of the pancreas to stimulate insulin secretion. This stimulation of Ia Insulin secretion is very fast, dependent on glucose levels in the environment, and is rapidly reversible when glucose levels decrease.
  • the thiazolidinediones act by improving the action of insulin by an increase in the activity of the PPAR range nuclear receptors. This alters the expression of a large number of genes that are involved in glucose and lipid metabolism, as well as in the insulin transduction signal.
  • Raskin et al (Raskin et al. Repaglinide / troglitazone combination therapy. Improved glycemic control in type 2 diabetes. Diabetes care. 2000; 23: 979-983), compared the efficacy and safety of the use of monotherapy with repaglinide, monotherapy with rosiglitazone, and the combined repaglinide / rosiglitazone therapy, in patients with type 2 diabetes with an unsatisfactory response to treatment with sulfonylurea or metformin, taking as changes in HbAIc (hemoglobin g icos ilad a) and FPG as indicators of treatment efficiency (fasting glucose).
  • HbAIc hemoglobin g icos ilad a
  • FPG as indicators of treatment efficiency (fasting glucose).
  • Rosenstock et al. (Rosenstock et al. Combination therapy with nateglinide and a thizolidinedione eimproves glycemic control in type 2 diabetes. Diabetes care. 2002; 25: 1529-1533), compared the efficacy of the combination of nateglinide and troglitazone in HbAIc of patients with type 2 diabetes inadequately controlled with diets, and found that with monotherapy separately with each of the components did not reach adequate HbAIc values ( ⁇ 7%), contrasting with those found for the combination of both agents, with which HbAIc values lower than 7% were reached.
  • Fonseca et al. (Fonseca et al. Addition of nagletinide to rosiglitazone monotherapy suppresses mealtime hyperglycemia and improves overall glycemic control. 2003. Diabetes care; 26: 1685-1690), studied the effect of adding nateglinide to monotherapy with rosiglitazone on the glycemic control, postprandial glucose and insulin levels in patients with type 2 diabetes.
  • HbAIc of about 0.6% compared to metformin monotherapy (Marre et al. Nateglinide added to metformin offers safe and affective treatment for type 2 diabetics (Abstract). Diabetes. 2000, Suppl. 1: A361).
  • Raskin et al. (Raskin et al. Efficacy and safety of combination therapy. Repaglinide plus metformin versus nateglinide plus metformin. Diabetes Care. 2003; 26: 2063-2068) studied the combination therapy repaglinide / metformin finding reduction in HbA (-1.28 % vs. -0.67%) and FPG (-39 vs. -21 mg / dl) significantly higher than those reported in each of the combined therapies.
  • a pharmaceutical composition formed by a benzotizolidinedione and a sulfonylurea protected a pharmaceutical composition formed by a benzotizolidinedione and a sulfonylurea.
  • the benzothiazolidinedione may be pioglitazone or troglitazone and sulfonylurea Ia glibenclamide, tolbutamide, tolazamide, acetohexamide, benzensulfonamide, carbitamide, glibonuride, glipizide etc.
  • glimepiride which is a new generation sulfonylurea in combination with pioglitazone.
  • the power of the combination in our invention is greater than those already patented by the inclusion of this component.
  • metformin-sulfonylurea The most commonly used combination therapy is metformin-sulfonylurea. These two types of agent have complementary mechanisms of action.
  • Microalbuminira is an important indicator of cardiovascular risk, and has been suggested as an indicator in patients with renal dysfunction.
  • Hanefeld studies (Hanefeld et al. One-year glycemic control with a sulfonylurea plus metformin in patients with type 2 diabetes. Diabetes care. 2004; 27: 141-147), showed that the addition of metformin to sulfonylurea therapy increases The secretion of albumin in the urine, by approximately 2%, thereby increasing the risk of nephropathy.
  • Raskin et al (Raskin et al. Repaglinide / troglitazone combination therapy. Improved glycemic control in type 2 diabetes. Diabetes care. 2000; 23: 979-983), studied the efficacy of the repaglinide / troglitazone combination in the treatment of type 2 diabetes mellitus, repaglinide is the first oral agent of the class of meglitinides to be available in the market, its mechanism of action is by stimulation of beta cells.
  • Troglitazone belongs to the class of benzothiazolidinediones (glitazones), which act by improving insulin sensitivity of peripheral tissues. In this therapy the main risks are in a matter of safety, due to the safety profile of troglitazone.
  • Troglitazone was introduced to the market in January 1997, to treat poorly controlled type 2 diabetics. At the end of the same year, doctors were alerted to the possible hepatoxicity of the medication. In England, troglitazone was voluntarily withdrawn from! market in December 1997 due to reports of serious adverse liver reactions. On March 21, 2000, the FDA announced the withdrawal of the troglitazone (FDA TaIk paper. Rezulin to be withdrawn from the market.
  • Fonseca et al (Fonseca et al. Addition of nagletinide to rosiglitazone monotherapy suppresses mealtime hyperglycemia and improves overall glycemic control. 2003. Diabetes care; 26: 1685-1690) and Raskin et al (Raskin et al. Combination therapy for type 2 diabetes: repaglinide plus rosiglitazone Diabetic medicine 2004; 21: 329-335), suggest the use of rosiglitazone in combination therapy with nateglinide and repag 1 in id a, respectively.
  • type 2 diabetes is associated with other comorbidities such as dyslipidemia, which increases the risk of cardiovascular disease. Therefore it would be desirable that the therapy carried out to reduce hyperglycemia also had an effect on the lipid profile.
  • rosiglitazone in doses of 4-8 mg / day significantly increases the levels of LDL-C (low density lipoproteins) and total cholesterol (Patel J., Anderson J., Rappaport EB. Rosiglitazone monotherapy improves glycaemic control in patients with type 2 diabetes: a twelve-week, randomized, placebo control led study. Diabetes Obes Metab, 1999; 1: 165-172; Nolan et al.
  • Rosiglitazone taken one daily provides effective glycaemic control in patients with type 2 diabetesmellitus.
  • Diabetic medicine 2004; 21: 329-335; Mayerson et al The effects of rosiglitazone on insulin sensitivity, lipolysis and hepatic and skeletal triglycerides contained in patients with type 2 diabetes. Diabetes. 2002; 51: 797-802), while pioglitazone is one of the few antidiabetic agents that produces improvements in the lipid profile.
  • Alphaglucosidase inhibitors decrease carbohydrate absorption by reducing postprandial hyperglycemia and it is expected that the combination of these with other drugs represents a better therapy for the treatment of diabetes.
  • Timmins et al 2000; US 6,031,004
  • acarbose metformin-alphag licosidase
  • the main disadvantage of this combination lies in the adverse effects of both agents.
  • the side effects of metformin are mainly gastrointestinal (nausea, vomiting, diarrhea, etc.).
  • Adverse reactions of acarbose are also at the level of the gastrointestinal tract, whereby combining these two agents enhances their adverse effects.
  • One of the objectives of the invention is to enable long-term management of the diabetic condition to maintain adequate glycemic control.
  • Another objective of the present invention is to achieve a more potent effect on hyperglycemia allowing dose reduction and therefore the individual side effects of drugs.
  • Still another objective is to achieve a pharmaceutical composition that allows to favor the lipid metabolism in the diabetic patient, also improving its profile in the blood plasma.
  • the present invention deals with a composition for the treatment of diabetes mellitus.
  • Said therapy consists of the combination of a hypo-glycemic agent belonging to the family of the new generation sulfonylurea specifically the glimepiride with a anti-hyperglycemic belonging to the family of benzothiazolidinediones or glitazones, specifically pioglitazone.
  • the present invention is also useful for the treatment of diabetes mellitus and its comorbidities.
  • This composition is established in the combination of pioglitazone and glimepiride. Both agents have different mechanisms of action in the treatment of diabetes.
  • This combination allows to have a more potent effect on the reduction of hyperglycemia, the reduction of the dose and therefore the individual side effects of each drug, in addition to delaying the insulin therapy in the patients, since in the monotherapy sooner or later
  • the administration of insulin will be required to control glucose levels, mainly due to the decrease in the response to the drug with respect to the time that occurs in the monotherapy.
  • the medications that form the combination therapy have been tested and approved individually.
  • the composition for the combination therapy consists of glimepiride and pioglitazone in doses of 2 mg and 15 mg / day, respectively.
  • the ratio that glimepiride should have with respect to pioglitazone will vary between 20 and 1000%, that is, while the Pioglitazone will vary between 5 to 2500 mg in each dose, the glimepiride will vary between 1 and 250 mg.
  • the invention of the present invention in its broadest form consists of a pharmaceutical composition for the treatment of diabetes and improvement of glycemic control comprising a combination of a hypoglycemic agent and an antihyperglycemic agent.
  • a hypoglycemic agent we have, in one of the modalities, a sulfonylurea.
  • a sulfonylurea is the glimepiride.
  • the antihyperglycemic agent in one of its modalities corresponds to a member of the family of benzothiazolidinediones.
  • the benzothiazolidinediones is pioglitazone
  • Pioglitazone belongs to the group of thiazolidinediones or glitazones, they are the only anti-hyperglycemic drugs that act directly on insulin resistance. They improve glycemic control by increasing the sensitivity to insulin in the tissues in which it acts, without increasing the dysfunctionality of beta cells.
  • this agent is related to the binding to a nuclear receptor, the range receptor activated by the peroxisome proliferator (PPAR range), once linked to these receptors they initiate a cascade of events that lead to the regulation of genes that code for Enzymes involved in the metabolism of glucose and lipids, triggering and promoting the transport of glucose into the cell, the metabolism of lipoproteins and decreasing the secretion of resistin, a new protein secreted by adiposites that interferes with the action from
  • PPAR range peroxisome proliferator
  • the insulin Due to their mechanism of action, they are important to prevent the loss of functionality of beta cells, which is an advantage with other therapies in which depletion of these cells occurs.
  • Glimepiride belongs to the group of second generation sulfonylureas, these agents are effective when there is residual activity of beta cells.
  • the sulfonylurea receptors in these cells are bound to the ATP-dependent potassium channels, when the agent binds to the receptors, these channels are closed and by a coupled reaction a calcium influx occurs and This triggers the secretion of insulin, this causes the blood glucose concentration to decrease, and also protects the beta cells from early exhaustion.
  • the present invention deals with a composition for the treatment of diabetes meliitus improving glycemic control.
  • Said composition consists of the combination of a hypoglycemic agent belonging to the family of the new generation sulfonylurea, specifically the glimepiride with an anti-hyperglycemic agent belonging to the family of benzothiazolidinediones or glitazones, specifically pioglitazone.
  • This therapeutic composition for the treatment of diabetes consists of the combination of two antidiabetic agents whose efficiency has been proven separately. These agents have different but complementary mechanisms of action that allow attacking this condition, using lower doses of each of the agents with the consequent decrease in adverse effects for the organism of the individual who consumes them.
  • the quantitative composition consists of glimepiride and pioglitazone in several ratios formed from 5 to 2500 mg of pioglitazone and approximately 1 to 250 mg of glimepiride, in one tablet, capsule, dragee, liquid intake, that is, in any pharmaceutical form.
  • each dose of the composition has 15 mg of pioglitazone and 2 mg of glimepiride.

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Diabetes (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne en général l'industrie pharmaceutique et l'industrie de fabrication de produits pharmaceutiques pour le traitement du diabète et de ses comorbidités. Les avantages présentés par l'invention par rapport aux compositions de l'art antérieur résident en ce que la composition de l'invention permet une gestion à long terme d'un état diabétique de manière à maintenir un contrôle glycémique adéquat ; en ce qu'elle produit un effet plus puissant sur l'hyperglycémie, ce qui permet de réduire la dose et les effets collatéraux individuels des médicaments ; et en ce qu'elle améliore la sensibilité à l'insuline des récepteurs bêta-pancréatiques, ce qui permet de corriger simultanément les troubles de sécrétion d'insuline et de favoriser le métabolisme lipidique, le profil de ce dernier étant ainsi amélioré dans le plasma sanguin. La composition de l'invention est formée par un agent hypoglycémiant et par un agent antihyperglycémiant, respectivement la glimépyride et la pioglitazone. La pioglitazone est présente dans la composition de l'invention à une quantité comprise entre 5 et 2500 mg, et la glimépyride à une quantité comprise entre 1 et 250 mg.
PCT/MX2005/000057 2004-09-23 2005-07-18 Composition synergique pour le traitement du diabete et de ses comorbidites Ceased WO2006033568A1 (fr)

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Application Number Priority Date Filing Date Title
MXPA/A/2004/009236 2004-09-23
MXPA04009236A MXPA04009236A (es) 2004-09-23 2004-09-23 Composicion sinergistica para el tratamiento de diabetes y sus comorbilidades.

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998036755A1 (fr) * 1997-02-19 1998-08-27 Warner Lambert Company Complexes medicamenteux pour le diabete, a base de sulfonyluree-glitazone
US6303640B1 (en) * 1995-06-20 2001-10-16 Takeda Chemical Industries, Ltd. Pharmaceutical composition

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6303640B1 (en) * 1995-06-20 2001-10-16 Takeda Chemical Industries, Ltd. Pharmaceutical composition
WO1998036755A1 (fr) * 1997-02-19 1998-08-27 Warner Lambert Company Complexes medicamenteux pour le diabete, a base de sulfonyluree-glitazone

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DEROSA G. ET AL: "A comparison of the effects of pioglitazone and rosiglitazone combined with glimepiride on prothrombotic state in type 2 diabetic patients with the metabolic syndrome", DIABETES RESEARCH AND CLINICAL PRACTICE, vol. 69, 2005, pages 5 - 13, XP025292788, DOI: doi:10.1016/j.diabres.2004.10.007 *
HANEFELD M. ET AL: "One-year glysemic conrol with a sulfonylurea plus pioglitozone versus a sulfonylurea plus metformin inpatients with type 2 diabetes", DIABETES CARE, vol. 27, no. 1, 2004, pages 141 - 147 *

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