Effects of pioglitazone and glimepiride on glycemic control and insulin sensitivity in Mexican patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, parallel-group trial

Clinical Therapeutics

Volumn 26, Issue 5, 2004, Pages 680-693

  Tan, Meng ^a   Johns, Don ^a   Gálvez, Guillermo González ^b   Antúnez, Oscar ^c   Fabián, Guadalupe ^d   Flores Lozano, Fernando ^e   Guajardo, Sergio Zúñiga ^f   Garza, Eduardo ^g   Morales, Hector ^a   Konkoy, Christopher ^a   Herz, Matthias ^a,h  

^a ELI LILLY AND COMPANY   (United States)

^b HOSPITAL CIVIL DE GUADALAJARA FRAY ANTONIO ALCALDE   (Mexico)

^c IMIC Research   (Mexico)

^d INSTITUTO NACIONAL DE ENFERMEDADES RESPIRATORIAS   (Mexico)

^e Hospital Dr Angel Leaño   (Mexico)

^f Clínica Cuauhtemoc y Famosa   (Mexico)

^g Clínica Hospital Solidaridad   (Mexico)

^h F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Glimepiride; Glycemic control; Hyperglycemia; Insulin resistance; Pioglitazone; Type 2 diabetes mellitus

Indexed keywords

ANTIDIABETIC AGENT; GLIMEPIRIDE; HEMOGLOBIN A1C; INSULIN; PIOGLITAZONE;

ADULT; ARTHRALGIA; ARTICLE; BODY WEIGHT DISORDER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EXERCISE; FEMALE; FLU LIKE SYNDROME; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPOGLYCEMIA; INSULIN BLOOD LEVEL; INSULIN SENSITIVITY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PERIPHERAL EDEMA; QUESTIONNAIRE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; TITRIMETRY; WEIGHT GAIN;

EID: 2942579255     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(04)90068-9     Document Type: Article

References (43)

1. Groop LC. Insulin resistance: The fundamental trigger of type 2 diabetes. Diabetes Obes Metab. 1999;1(Suppl 1):S1-S7.
2. Unger RH, Zhou YT. Lipotoxicity of beta-cells in obesity and in other causes of fatty acid spillover. Diabetes. 2001;50(Suppl 1):S118-S121.
3. Leahy JL. Glucose toxicity of the β-cell. In: LeRoith D, Taylor SI, Olefsky JM, eds. Diabetes Mellitus: A Fundamental and Clinical Text. Philadelphia: Lippincott Williams & Wilkins; 2000:115-125.
4. UK Prospective Diabetes (UKPDS) Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853.
5. Müller G. The molecular mechanism of the insulin-mimetic/sensitizing activity of the antidiabetic sulfonylurea drug Amaryl. Molecular Med. 2000;11:907-933.
6. Hsia SH, Davidson MB. Established therapies for diabetes mellitus. Curr Med Res Opin. 2002;18(Suppl 1):S13-S21.
7. Goldberg RB, Holvey SM, Schneider J, for the Glimepiride Protocol #201 Study Group. A dose-response study of glimepiride in patients with NIDDM who had previously received sulfonylurea agents. Diabetes Care. 1996;19:849-856.
8. Draeger KE, Wernicke-Panten K, Lomp HJ, et al. Long-term treatment of type 2 diabetic patients with the new oral antidiabetic agent glimepiride (Amaryl®): A double-blind comparison with glibenclamide. Horm Metab Res. 1996;28:419-425.
9. Holstein A, Plaschke A, Egberts EH. Lower incidence of severe hypoglycaemia in patients with type 2 diabetes treated with glimepiride versus glibenclamide. Diabetes Metab Res Rev. 2001;17:467-473.
10. Geisen K, Végh A, Krause E, Papp JG. Cardiovascular effects of conventional sulfonylureas and glimepiride. Horm Metab Res. 1996;28:496-507.
11. Feinglos MN, Bethel MA. Oral agent therapy in the treatment of type 2 diabetes. Diabetes Care. 1999;22(Suppl 3):C61-C64.
12. Saltiel AR, Olefsky JM. Thiazolidinediones in the treatment of insulin resistance and type II diabetes. Diabetes. 1996;45:1661-1669.
13. Vosper H, Khoudoli GA, Graham TL, Palmer CNA. Peroxisome proliferator-activated receptor agonists, hyperlipidaemia, and atherosclerosis. Pharmacol Ther. 2002;95:47-62.
14. Tan MH. Current treatment of insulin resistance in type 2 diabetes mellitus. Int J Clin Pract. 2000;113(Suppl):54-62.
15. Aronoff S, Rosenblatt S, Braithwaite S, et al, for the Pioglitazone 001 Study Group. Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: A 6-month randomized placebo-controlled dose-response study. Diabetes Care. 2000;23:1605-1611.
16. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-986.
17. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972;18:499-502.
18. Levy JC, Matthews DR, Hermans MP. Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 1998;21:2191-2192.
19. Katz A, Nambi SS, Mather K, et al. Quantitative insulin sensitivity check index: A simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000;85:2402-2410.
20. Seidel HM, Ball JW, Dains JE, Benedict GW, eds. Heart and blood vessels. In: Mosby's Guide to Physical Examination. 4th ed. St Louis, Mo: Mosby, Inc; 1999;409-485.
21. Cochran WG, Cox GM. Notes on the statistical analysis of the results. In: Experimental Designs. 2nd ed. New York: John Wiley & Sons; 1957:45-94.
22. Agresti A. Inference for two-way contingency tables. In: Categorical Data Analysis. New York: John Wiley & Sons; 1990:36-78.
23. Amaryl [package insert]. Bridgewater, NJ: Aventis Pharmaceuticals, Inc; 2003.
24. Radziuk J. Insulin sensitivity and its measurement: Structural commonalities among the methods. J Clin Endocrinol Metab. 2000;85:4426-4433.
25. Bonora E, Targher G, Alberiche M, et al. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity. Studies in subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care. 2000;23:57-63.
26. Korytkowsky M, Thomas A, Reid L, et al. Glimepiride improves both first and second phases of insulin secretion in type 2 diabetes. Diabetes Care. 2002;25:1607-1611.
27. Turner RC, Cull CA, Frighi V̇, Holman RR, for the UK Prospective Diabetes Study (UKPDS) Group. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: Progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999;281:2005-2012.
28. Dills DG, Schneider J, for the Glimepiride/Glyburide Research Group. Clinical evaluation of glimepiride versus glyburide in NIDDM in a double-blind comparative study. Horm Metab Res. 1996;28:426-429.
29. Rosenblatt S, Miskin B, Glazer NB, et al. The impact of pioglitazone on glycemic control and atherogenic dyslipidemia in patients with type 2 diabetes mellitus. Coron Artery Dis. 2001;12:413-423.
30. Wagner AM, Jorba O, Rigla M, et al. LDL-cholesterol/apolipoprotein B ratio is a good predictor of LDL phenotype B in type 2 diabetes. Acta Diabetol. 2002;39:215-220.
31. Winkler K, Friedrich I, Baumstark MW, et al. Pioglitazone reduces atherogenic dense low density lipoprotein (LDL) particles in patients with type 2 diabetes mellitus. Br J Diabetes Vasc Dis. 2002;2:143-148.
32. Martens FMAC, Visseren FL, Lemay J, et al. Metabolic and additional vascular effects of thiazolidinediones. Drugs. 2002;62:1463-1480.
33. Miyazaki Y, Matsuda M, DeFronzo RA. Dose-response effect of pioglitazone on insulin sensitivity and insulin secretion in type 2 diabetes. Diabetes Care. 2002;25:517-523.
34. Mori Y, Murakawa Y, Okada K, et al. Effect of troglitazone on body fat distribution in type 2 diabetic patients. Diabetes Care. 1999;22:908-912.
35. Nakamura T, Funahashi T, Yamashita S, et al. Thiazolidinedione derivative improves fat distribution and multiple risk factors in subjects with visceral fat accumulation - double-blind placebo-controlled trial. Diabetes Res Clin Pract. 2001;54:181-190.
36. Miyazaki Y, Mahankali A, Matsuda M, et al. Effect of pioglitazone on abdominal fat distribution and insulin sensitivity in type 2 diabetic patients. J Clin Endocrinol Metab. 2002;87:2784-2791.
37. Kipnes MS, Krosnick A, Rendell MS, et al. Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: A randomized, placebo-controlled study. Am J Med. 2001;111:10-17.
38. Burge MR, Sood V, Sobhy TA, et al. Sulphonylurea-induced hypoglycaemia in type 2 diabetes mellitus: A review. Diabetes Obes Metab. 1999;1:199-206.
39. Herz M, Johns D, Reviriego J, et al. A randomized, double-blind, placebo-controlled, clinical trial of the effects of pioglitazone on glycemic control and dyslipidemia in oral antihyperglycemic medication-naive patients with type 2 diabetes mellitus. Clin Ther. 2003;25:1074-1095.
40. Pavo I, Jermendy G, Varkonyi T, et al. Effect of pioglitazone compared with metformin on glycemic control and indicators of insulin sensitivity in recently diagnosed patients with type 2 diabetes. J Clin Endocrinol Metab. 2003;88:1637-1645.
41. Bajaj M, Suraamornkul S, Pratipanawatr T, et al. Pioglitazone reduces hepatic fat content and augments splanchnic glucose uptake in patients with type 2 diabetes. Diabetes. 2003;52:1364-1370.
42. Freedman R, Uwaifo G, Lutchman G, et al. Changes in insulin sensitivity and improvements in liver histology in patients with nonalcoholic steatohepatitis (NASH) treated with pioglitazone (PIO). Diabetes. 2003;52 (Suppl 1):A76. Abstract.
43. Reaven GM. Insulin resistance and its consequences: Type 2 diabetes mellitus and coronary heart disease. In: LeRoith D, Taylor SI, Olefsky JM, eds. Diabetes Mellitus: A Fundamental and Clinical Text. Philadelphia: Lippincott Williams & Wilkins; 2000:604-615.