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The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2 diabetes patients, in a 12 months follow up.
Metformin glycinate salt is a new drug , which has better pharmacokinetic characteristics (better bioavailability and absorption) making a proper antihyperglycemic power without increasing the frequency of adverse effects. The drug has been tested in preclinical test with animals, in healthy subjects and in patients with type 2 diabetes; which showed that it has adequate antihyperglycemic effect. Now, its important to compare metformin glycinate and metformin hydrochloride for evaluate the relative antihyperglicemic power. In addition, a study with a larger number of patients improve the statistical power of the test to investigate the effects of these drugs on possible weight loss and lipid profile improve. Additionally, it will also explore the relative power of the two medications tested to modify inflammatory response mediators and oxidative stress have been associated with the incidence of cardiovascular disease in diabetes. This project was designed with the intent to answer the next question: What are the efficacy and safety of metformin glycinate dose of 2101.2 mg/day (equivalent to 1700 mg/day metformin hydrochloride), compared with metformin hydrochloride in doses of 1700 mg/day for 12 months of treatment in patients with Type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin glycinate | Experimental | Metformin glycinate is a new biguanide, for this study the dose administrated will be 1050.6 mg OD for a month, and 1050.6 mg BID for 11 moths. |
|
| Metformin Hydrochloride | Active Comparator | Metformin Hydrochloride is the biguanide most used, for this study the dose administrated will be 850 mg OD for a month, and 850 mg BID for 11 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin glycinate | Drug | Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | HbA1c: Measured by electrophoresis of lacked total blood using Paragon system and Appraise reader 44800 (Beckman Instruments de Mexico). Fasting Glucose: in serum using glucose oxidase technique with BM/Hitachi 704/911 automated analyzer | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | 12 months | |
| Total cholesterol | 12 months | |
| High-density lipoprotein (HDL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels H Wacher, PhD | IMSS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paracelsus S.A. de C.V. | Mexico City | AA | 03800 | Mexico | ||
| Unidad Antidiabética Integral |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7895460 | Background | Hermann LS, Schersten B, Melander A. Antihyperglycaemic efficacy, response prediction and dose-response relations of treatment with metformin and sulphonylurea, alone and in primary combination. Diabet Med. 1994 Dec;11(10):953-60. doi: 10.1111/j.1464-5491.1994.tb00253.x. | |
| 15787679 | Background | Johnson JA, Simpson SH, Toth EL, Majumdar SR. Reduced cardiovascular morbidity and mortality associated with metformin use in subjects with Type 2 diabetes. Diabet Med. 2005 Apr;22(4):497-502. doi: 10.1111/j.1464-5491.2005.01448.x. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin hydrochloride | Drug | 12 months: 1 month, once daily dose of 850 mg (before dinner) and 11 months, twice daily dose 850 mg (before breakfast) + 850 mg (before dinner). |
|
|
| 12 months |
| Low-density lipoprotein (LDL) | 12 months |
| Triglycerides | 12 months |
| Tumor necrosis factor-alpha (TNF-α) | 12 months |
| Adiponectin | 12 months |
| Resistin | 12 months |
| Interleukin-1 beta (IL-1β) | 12 months |
| Number of Adverse Events as a Measure of Safety and Tolerability | 12 months |
| Malonylaldehyde | 12 months |
| Dismutase superoxide | 12 months |
| Mexico City |
| AA |
| 06600 |
| Mexico |
| Instituto de terapéutica experimental y clínica (INTEC) | Guadalajara | Jalisco | 44600 | Mexico |
| Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social | Mexico City | Mexico City | 06720 | Mexico |
| 20388897 | Background | Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010 Apr 14;303(14):1410-8. doi: 10.1001/jama.2010.405. |
| 9742977 | Background | Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65. |
| 18784090 | Background | Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10. |
| 19959591 | Background | Tzoulaki I, Molokhia M, Curcin V, Little MP, Millett CJ, Ng A, Hughes RI, Khunti K, Wilkins MR, Majeed A, Elliott P. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ. 2009 Dec 3;339:b4731. doi: 10.1136/bmj.b4731. |
| 18955635 | Background | Selvin E, Bolen S, Yeh HC, Wiley C, Wilson LM, Marinopoulos SS, Feldman L, Vassy J, Wilson R, Bass EB, Brancati FL. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008 Oct 27;168(19):2070-80. doi: 10.1001/archinte.168.19.2070. |
| 18955637 | Result | Alexander GC, Sehgal NL, Moloney RM, Stafford RS. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med. 2008 Oct 27;168(19):2088-94. doi: 10.1001/archinte.168.19.2088. |
| D004700 | Endocrine System Diseases |