metformin has been researched along with Adverse Drug Event in 49 studies
Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.
| Excerpt | Relevance | Reference |
|---|---|---|
| "The purpose of this study is to evaluate the effectiveness and safety of liraglutide/liraglutide + metformin in overweight/obese women with polycystic ovary syndrome (PCOS)." | 9.22 | The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis. ( Ge, JJ; Ge, WH; Shen, SM; Song, W; Wang, DJ, 2022) |
| "Combining metformin and lifestyle intervention shows significant effect in reducing AP-related weight gain." | 9.01 | Combination of Metformin and Lifestyle Intervention for Antipsychotic-Related Weight Gain: A Meta-Analysis of Randomized Controlled Trials. ( Cai, DB; Ng, CH; Ungvari, GS; Wu, RR; Xiang, YT; Yang, XH; Zhang, QE; Zheng, W, 2019) |
| "To estimate the incidence rate of lactic acidosis in patients with type 2 diabetes mellitus as well as to estimate the relative risk of lactic acidosis associated with metformin treatment." | 7.88 | Risk of lactic acidosis in type 2 diabetes patients using metformin: A case control study. ( Aharaz, A; Beck-Nielsen, H; Hallas, J; Henriksen, DP; Lassen, AT; Pottegård, A, 2018) |
| " Metformin-associated lactic acidosis (MALA) is one such rare, life-threatening adverse drug effect." | 7.88 | Metformin-associated lactic acidosis precipitated by liraglutide use: adverse effects of aggressive antihyperglycaemic therapy. ( Hannallah, F; Hooda, A; Mehta, A, 2018) |
| "Whether metformin precipitates lactic acidosis in patients with chronic kidney disease (CKD) remains under debate." | 7.85 | Risk of acute kidney injury and survival in patients treated with Metformin: an observational cohort study. ( Bell, S; Colhoun, HM; Farran, B; Leese, GP; Lindsay, R; Looker, H; McCrimmon, RJ; McGurnaghan, S; McKeigue, P; McKnight, J; Petrie, JR; Sattar, N; Wild, S, 2017) |
| "Metformin is a widely used and effective medication in type 2 diabetes (T2DM) as well as in polycystic ovary syndrome (PCOS)." | 5.41 | Identification of Novel Intronic SNPs in Transporter Genes Associated with Metformin Side Effects. ( Obermayer, A; Obermayer-Pietsch, B; Schweighofer, N; Sourij, C; Sourij, H; Strasser, M; Trummer, O, 2023) |
| "The purpose of this study is to evaluate the effectiveness and safety of liraglutide/liraglutide + metformin in overweight/obese women with polycystic ovary syndrome (PCOS)." | 5.22 | The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis. ( Ge, JJ; Ge, WH; Shen, SM; Song, W; Wang, DJ, 2022) |
| "Roflumilast added to metformin reduced body weight in obese women with PCOS, primarily due to a loss of fat mass." | 5.19 | Phosphodiesterase 4 inhibition as a potential new therapeutic target in obese women with polycystic ovary syndrome. ( Janez, A; Jensterle, M; Kocjan, T, 2014) |
| "Combining metformin and lifestyle intervention shows significant effect in reducing AP-related weight gain." | 5.01 | Combination of Metformin and Lifestyle Intervention for Antipsychotic-Related Weight Gain: A Meta-Analysis of Randomized Controlled Trials. ( Cai, DB; Ng, CH; Ungvari, GS; Wu, RR; Xiang, YT; Yang, XH; Zhang, QE; Zheng, W, 2019) |
| "To estimate the incidence rate of lactic acidosis in patients with type 2 diabetes mellitus as well as to estimate the relative risk of lactic acidosis associated with metformin treatment." | 3.88 | Risk of lactic acidosis in type 2 diabetes patients using metformin: A case control study. ( Aharaz, A; Beck-Nielsen, H; Hallas, J; Henriksen, DP; Lassen, AT; Pottegård, A, 2018) |
| " Metformin-associated lactic acidosis (MALA) is one such rare, life-threatening adverse drug effect." | 3.88 | Metformin-associated lactic acidosis precipitated by liraglutide use: adverse effects of aggressive antihyperglycaemic therapy. ( Hannallah, F; Hooda, A; Mehta, A, 2018) |
| "Whether metformin precipitates lactic acidosis in patients with chronic kidney disease (CKD) remains under debate." | 3.85 | Risk of acute kidney injury and survival in patients treated with Metformin: an observational cohort study. ( Bell, S; Colhoun, HM; Farran, B; Leese, GP; Lindsay, R; Looker, H; McCrimmon, RJ; McGurnaghan, S; McKeigue, P; McKnight, J; Petrie, JR; Sattar, N; Wild, S, 2017) |
| "These data indicate the presence of a coexisting risk factor, other than metformin use, associated with metabolic acidosis after contrast medium exposure." | 3.83 | The association between use of metformin and change in serum CO2 level after administration of contrast medium. ( Baek, JH; Hahm, JR; Jung, J; Jung, JH; Kim, KY; Kim, SK, 2016) |
| " Metformin - an oral hypoglycemic drug universally recommended as the first-line treatment for type 2 diabetes mellitus (T2DM) - undergoes significant accumulation in advanced CKD that may ultimately lead to lactic acidosis." | 3.81 | Prescription-medication sharing among family members: an unrecognized cause of a serious drug adverse event in a patient with impaired renal function. ( Makówka, A; Nowicki, M; Zawiasa, A, 2015) |
| "Metformin has been used for ages to treat diabetes mellitus due to its safety profile and low cost." | 3.01 | Metformin derivatives - Researchers' friends or foes? ( Huttunen, KM; Markowicz-Piasecka, M; Tampio, J; Torunoglu, ST; Zajda, A, 2023) |
| "Post-metformin increase in AMPK phosphorylation may potentially explain lack of disease progression in nearly half of our patients." | 2.90 | A phase I delayed-start, randomized and pharmacodynamic study of metformin and chemotherapy in patients with solid tumors. ( Caplain, J; Das, M; Grimm, E; Martell, R; Rajagopal, S; Saif, MW; Serebrennikova, O; Tsichlis, PN, 2019) |
| "3% of patients experienced adverse events with placebo, ertugliflozin 5- and 15 mg, respectively." | 2.90 | Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia. ( Huyck, S; Ji, L; Lauring, B; Liu, S; Liu, Y; Miao, H; Mu, Y; Pan, S; Qiu, Y; Terra, SG; Wang, W; Xie, Y; Yan, P; Yang, M, 2019) |
| "Metformin thus seems to be a promising drug for preventing metabolic side effects during systemic glucocorticoid treatment." | 2.84 | Metformin prevents metabolic side effects during systemic glucocorticoid treatment. ( Bally, M; Christ-Crain, M; Korbonits, M; Meyer, S; Müller, B; Nigro, N; Pernicova, I; Schuetz, P; Seelig, E; Timper, K, 2017) |
| " The primary objective was to demonstrate that HbA(1c) reduction with once-daily vildagliptin 100 mg AM dosing is superior to placebo." | 2.74 | Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. ( Goodman, M; Penman, J; Thurston, H, 2009) |
| "To achieve glycemic control in type 2 diabetes mellitus (T2DM), multiple oral agents are used in a stepwise approach, but long-term maintenance of normoglycemia is difficult to achieve, and, eventually, most patients require insulin." | 2.73 | Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted. ( Adams-Huet, B; Kaloyanova, PF; Lingvay, I; Raskin, P; Salinas, K, 2007) |
| " Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed." | 2.53 | Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report. ( Kshirsagar, NA; Pai, SA, 2016) |
| " Due to a lack of means, the dosage of homocysteine and methylmalonic acid had not been carried out to confirm the vitamin B12 deficiency in the patient whose level was less than 200ng/mL." | 1.91 | [Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès]. ( Belakhdar, K; Kraroubi, A; Matmour, D; Sakouhi, M, 2023) |
| "Metformin was the most prescribed monotherapy drug between 2015 and 2020." | 1.72 | Metformin-based single pill drug combinations for type 2 diabetes in primary care England: A time trend analysis. ( Aslam, Q; Babar, ZUD; Hasan, SS; Islam, I; Kow, CS, 2022) |
| "Metformin hydrochloride (metformin HCL), a first-line drug treating diabetes type II, was known to cause severe gastritis, so seeking a non-oral dosage form was the new trend." | 1.72 | Evaluation of Metformin Hydrochloride Tailoring Bilosomes as an Effective Transdermal Nanocarrier. ( Ali, AA; Elsisi, AA; Khalil, NM; Nafady, MM; Salem, HF, 2022) |
| "Sex differences in reported ADRs were seen in the first weeks after metformin initiation, whereas statistically significant differences in self-reported prescribed dosing were observed after several months." | 1.56 | Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study. ( de Vries, ST; Denig, P; Ekhart, C; Mol, PGM; van Puijenbroek, EP, 2020) |
| "A total of 66,807 people with type 2 diabetes were treated with metformin (MET) plus a combination of second- and third-line therapies." | 1.56 | Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and All-Cause Mortality for Widely Used Antihyperglycemic Dual and Triple Therapies for Type 2 Diabetes Management: A Cohort Study of All Danish Users. ( Hejlesen, O; Jakobsen, PE; Jensen, MH; Kjolby, M; Vestergaard, P, 2020) |
| " In other words, which compounds are least likely to cause harm, while still potentially providing benefit? To systematically answer this question we queried the DrugAge database-containing hundreds of known geroprotectors-and cross-referenced this with a recently published repository of compound side effect predictions." | 1.56 | Identification of longevity compounds with minimized probabilities of side effects. ( Houtkooper, RH; Janssens, GE, 2020) |
| "Adverse drug reactions were assessed using patient-reported gastrointestinal intolerance and hypoglycemic symptoms." | 1.46 | Evaluation of the concurrent use of dolutegravir and metformin in human immunodeficiency virus-infected patients. ( Badowski, ME; Fulco, PP; Liedtke, MD; Masich, A, 2017) |
| "Metformin was the most common PIM at admission." | 1.42 | Retrospective evaluation of potentially inappropriate prescribing in hospitalized patients with renal impairment. ( Castelino, RL; Doody, HK; Peterson, GM; Watson, D, 2015) |
| "Metformin use was clearly associated with lower vitamin B12 levels." | 1.36 | Association between vitamin B12 levels and mortality in hospitalized older adults. ( Malnick, S; Shavit, Y; Stern, F; Tal, S, 2010) |
| "5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects." | 1.32 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. ( Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 5 (10.20) | 29.6817 |
| 2010's | 27 (55.10) | 24.3611 |
| 2020's | 17 (34.69) | 2.80 |
| Authors | Studies |
|---|---|
| Matthews, EJ | 1 |
| Kruhlak, NL | 1 |
| Weaver, JL | 1 |
| Benz, RD | 1 |
| Contrera, JF | 1 |
| Liu, Z | 3 |
| Shi, Q | 1 |
| Ding, D | 2 |
| Kelly, R | 1 |
| Fang, H | 1 |
| Tong, W | 1 |
| Morgan, RE | 1 |
| van Staden, CJ | 1 |
| Chen, Y | 4 |
| Kalyanaraman, N | 1 |
| Kalanzi, J | 1 |
| Dunn, RT | 1 |
| Afshari, CA | 1 |
| Hamadeh, HK | 1 |
| Hasan, SS | 1 |
| Aslam, Q | 1 |
| Islam, I | 1 |
| Kow, CS | 1 |
| Babar, ZUD | 1 |
| Salem, HF | 1 |
| Nafady, MM | 1 |
| Ali, AA | 1 |
| Khalil, NM | 1 |
| Elsisi, AA | 1 |
| Sakouhi, M | 3 |
| Matmour, D | 3 |
| Belakhdar, K | 3 |
| Kraroubi, A | 3 |
| Faquetti, ML | 1 |
| la Torre, AM | 1 |
| Burkard, T | 1 |
| Obozinski, G | 1 |
| Burden, AM | 1 |
| Pollack, BE | 1 |
| Barbaro, RP | 1 |
| Selewski, DT | 1 |
| Carlton, EF | 1 |
| Karmanova, E | 1 |
| Chernikov, A | 1 |
| Usacheva, A | 1 |
| Ivanov, V | 1 |
| Bruskov, V | 1 |
| Torunoglu, ST | 1 |
| Zajda, A | 1 |
| Tampio, J | 1 |
| Markowicz-Piasecka, M | 1 |
| Huttunen, KM | 1 |
| Schweighofer, N | 1 |
| Strasser, M | 1 |
| Obermayer, A | 1 |
| Trummer, O | 1 |
| Sourij, H | 1 |
| Sourij, C | 1 |
| Obermayer-Pietsch, B | 1 |
| Saif, MW | 1 |
| Rajagopal, S | 1 |
| Caplain, J | 1 |
| Grimm, E | 1 |
| Serebrennikova, O | 1 |
| Das, M | 1 |
| Tsichlis, PN | 1 |
| Martell, R | 1 |
| de Vries, ST | 1 |
| Denig, P | 1 |
| Ekhart, C | 1 |
| Mol, PGM | 1 |
| van Puijenbroek, EP | 1 |
| Jensen, MH | 1 |
| Kjolby, M | 1 |
| Hejlesen, O | 1 |
| Jakobsen, PE | 1 |
| Vestergaard, P | 1 |
| Weersma, RK | 1 |
| Zhernakova, A | 1 |
| Fu, J | 1 |
| Janssens, GE | 1 |
| Houtkooper, RH | 1 |
| Nguépy Keubo, FR | 1 |
| Mboua, PC | 1 |
| Djifack Tadongfack, T | 1 |
| Fokouong Tchoffo, E | 1 |
| Tasson Tatang, C | 1 |
| Ide Zeuna, J | 1 |
| Noupoue, EM | 1 |
| Tsoplifack, CB | 1 |
| Folefack, GO | 1 |
| Kettani, M | 1 |
| Bandelier, P | 1 |
| Huo, J | 1 |
| Li, H | 4 |
| Yu, D | 1 |
| Arulsamy, N | 1 |
| AlAbbad, S | 1 |
| Sardot, T | 1 |
| Lekashvili, O | 1 |
| Decato, D | 1 |
| Lelj, F | 1 |
| Alexander Ross, JB | 1 |
| Rosenberg, E | 1 |
| Nazir, H | 1 |
| Muthuswamy, N | 1 |
| Louis, C | 1 |
| Jose, S | 1 |
| Prakash, J | 1 |
| Buan, MEM | 1 |
| Flox, C | 1 |
| Chavan, S | 1 |
| Shi, X | 1 |
| Kauranen, P | 1 |
| Kallio, T | 1 |
| Maia, G | 1 |
| Tammeveski, K | 1 |
| Lymperopoulos, N | 1 |
| Carcadea, E | 1 |
| Veziroglu, E | 1 |
| Iranzo, A | 1 |
| M Kannan, A | 1 |
| Arunamata, A | 1 |
| Tacy, TA | 1 |
| Kache, S | 1 |
| Mainwaring, RD | 1 |
| Ma, M | 1 |
| Maeda, K | 1 |
| Punn, R | 1 |
| Noguchi, S | 1 |
| Hahn, S | 3 |
| Iwasa, Y | 3 |
| Ling, J | 2 |
| Voccio, JP | 2 |
| Kim, Y | 3 |
| Song, J | 3 |
| Bascuñán, J | 2 |
| Chu, Y | 1 |
| Tomita, M | 1 |
| Cazorla, M | 1 |
| Herrera, E | 1 |
| Palomeque, E | 1 |
| Saud, N | 1 |
| Hoplock, LB | 1 |
| Lobchuk, MM | 1 |
| Lemoine, J | 1 |
| Li, X | 10 |
| Henson, MA | 1 |
| Unsihuay, D | 1 |
| Qiu, J | 1 |
| Swaroop, S | 1 |
| Nagornov, KO | 1 |
| Kozhinov, AN | 1 |
| Tsybin, YO | 1 |
| Kuang, S | 1 |
| Laskin, J | 1 |
| Zin, NNINM | 1 |
| Mohamad, MN | 1 |
| Roslan, K | 1 |
| Abdul Wafi, S | 1 |
| Abdul Moin, NI | 1 |
| Alias, A | 1 |
| Zakaria, Y | 1 |
| Abu-Bakar, N | 1 |
| Naveed, A | 1 |
| Jilani, K | 1 |
| Siddique, AB | 1 |
| Akbar, M | 1 |
| Riaz, M | 1 |
| Mushtaq, Z | 1 |
| Sikandar, M | 1 |
| Ilyas, S | 1 |
| Bibi, I | 1 |
| Asghar, A | 1 |
| Rasool, G | 1 |
| Irfan, M | 1 |
| Li, XY | 1 |
| Zhao, S | 1 |
| Fan, XH | 1 |
| Chen, KP | 1 |
| Hua, W | 1 |
| Liu, ZM | 1 |
| Xue, XD | 1 |
| Zhou, B | 1 |
| Zhang, S | 2 |
| Xing, YL | 1 |
| Chen, MA | 1 |
| Sun, Y | 1 |
| Neradilek, MB | 1 |
| Wu, XT | 1 |
| Zhang, D | 2 |
| Huang, W | 1 |
| Cui, Y | 1 |
| Yang, QQ | 1 |
| Li, HW | 1 |
| Zhao, XQ | 1 |
| Hossein Rashidi, B | 1 |
| Tarafdari, A | 1 |
| Ghazimirsaeed, ST | 1 |
| Shahrokh Tehraninezhad, E | 1 |
| Keikha, F | 1 |
| Eslami, B | 1 |
| Ghazimirsaeed, SM | 1 |
| Jafarabadi, M | 1 |
| Silvani, Y | 1 |
| Lovita, AND | 1 |
| Maharani, A | 1 |
| Wiyasa, IWA | 1 |
| Sujuti, H | 1 |
| Ratnawati, R | 1 |
| Raras, TYM | 1 |
| Lemin, AS | 1 |
| Rahman, MM | 1 |
| Pangarah, CA | 1 |
| Kiyu, A | 1 |
| Zeng, C | 2 |
| Du, H | 1 |
| Lin, D | 1 |
| Jalan, D | 1 |
| Rubagumya, F | 1 |
| Hopman, WM | 1 |
| Vanderpuye, V | 1 |
| Lopes, G | 1 |
| Seruga, B | 1 |
| Booth, CM | 1 |
| Berry, S | 1 |
| Hammad, N | 1 |
| Sajo, EA | 1 |
| Okunade, KS | 1 |
| Olorunfemi, G | 1 |
| Rabiu, KA | 1 |
| Anorlu, RI | 1 |
| Xu, C | 2 |
| Xiang, Y | 1 |
| Xu, X | 1 |
| Zhou, L | 2 |
| Dong, X | 1 |
| Tang, S | 1 |
| Gao, XC | 1 |
| Wei, CH | 1 |
| Zhang, RG | 1 |
| Cai, Q | 1 |
| He, Y | 1 |
| Tong, F | 1 |
| Dong, JH | 1 |
| Wu, G | 1 |
| Dong, XR | 1 |
| Tang, X | 1 |
| Tao, F | 1 |
| Xiang, W | 1 |
| Zhao, Y | 2 |
| Jin, L | 1 |
| Tao, H | 1 |
| Lei, Y | 1 |
| Gan, H | 1 |
| Huang, Y | 1 |
| Chen, L | 3 |
| Shan, A | 1 |
| Zhao, H | 2 |
| Wu, M | 2 |
| Ma, Q | 1 |
| Wang, J | 4 |
| Zhang, E | 1 |
| Zhang, J | 3 |
| Li, Y | 5 |
| Xue, F | 1 |
| Deng, L | 1 |
| Liu, L | 2 |
| Yan, Z | 2 |
| Wang, Y | 2 |
| Meng, J | 1 |
| Chen, G | 2 |
| Anastassiadou, M | 1 |
| Bernasconi, G | 1 |
| Brancato, A | 1 |
| Carrasco Cabrera, L | 1 |
| Greco, L | 1 |
| Jarrah, S | 1 |
| Kazocina, A | 1 |
| Leuschner, R | 1 |
| Magrans, JO | 1 |
| Miron, I | 1 |
| Nave, S | 1 |
| Pedersen, R | 1 |
| Reich, H | 1 |
| Rojas, A | 1 |
| Sacchi, A | 1 |
| Santos, M | 1 |
| Theobald, A | 1 |
| Vagenende, B | 1 |
| Verani, A | 1 |
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| Liu, X | 1 |
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| Li, J | 7 |
| Li, P | 1 |
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| Wang, F | 2 |
| Wang, YS | 1 |
| Wang, C | 3 |
| Zhou, X | 2 |
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| Hou, J | 1 |
| Zhang, A | 1 |
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| Wu, X | 1 |
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| Wu, W | 1 |
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| Ji, H | 1 |
| Yang, X | 2 |
| Xu, Z | 1 |
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| Wei, Y | 2 |
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| Kang, KW | 1 |
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| Pajuelo-Lozano, N | 1 |
| Alcalá, S | 1 |
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| Sanchez-Perez, I | 1 |
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| Alpers, M | 1 |
| Singh, KP | 1 |
| Wolkenhauer, O | 1 |
| Heckl, D | 1 |
| Spitschak, A | 1 |
| Pützer, BM | 1 |
| Liao, Y | 1 |
| Cheng, J | 1 |
| Kong, X | 1 |
| Li, S | 1 |
| Zhang, M | 4 |
| Zhang, H | 1 |
| Yang, T | 2 |
| Dong, Y | 1 |
| Xu, Y | 1 |
| Yuan, Z | 1 |
| Cao, J | 1 |
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| Yao, Y | 1 |
| Liang, C | 1 |
| Yang, H | 1 |
| Song, Y | 1 |
| Yu, K | 1 |
| Zhu, C | 1 |
| Huang, Z | 1 |
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| Hu, J | 2 |
| Wang, H | 2 |
| Liu, Y | 5 |
| Mi, Y | 1 |
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| Luo, X | 1 |
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| Chang, X | 2 |
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| Rathore, MG | 1 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Prospective Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy[NCT01442870] | Phase 1 | 105 participants (Actual) | Interventional | 2011-09-30 | Completed | ||
| Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study[NCT05702905] | Phase 4 | 75 participants (Anticipated) | Interventional | 2023-04-30 | Not yet recruiting | ||
| A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy (VERTIS-ASIA)[NCT02630706] | Phase 3 | 506 participants (Actual) | Interventional | 2015-12-16 | Completed | ||
| Efficacy of metfOrmin in PrevenTIng Glucocorticoid-induced Diabetes in Melanoma, breAst or Lung Cancer Patients With Brain Metastases: the Phase II OPTIMAL Study[NCT04001725] | Phase 2 | 110 participants (Anticipated) | Interventional | 2019-10-15 | Recruiting | ||
| Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes[NCT00102388] | Phase 3 | 1,092 participants (Actual) | Interventional | 2005-01-31 | Completed | ||
| A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy[NCT00351884] | Phase 3 | 370 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
| Preservation of Beta-cell Function in Type 2 Diabetes Mellitus[NCT00232583] | 58 participants (Actual) | Interventional | 2003-11-30 | Completed | |||
| Pharmacist-led Intervention to Reduce Potentially Inappropriate Prescription in Elderly and Polypharmacy Patients at Primary Care Setting (PHARM-PC) Cluster Randomized Trial[NCT02224833] | 549 participants (Actual) | Interventional | 2015-01-31 | Completed | |||
| Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria[NCT01467050] | Phase 4 | 732 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Percentage A1C (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -1.00 |
| Ertugliflozin 15 mg | -0.89 |
| Placebo | -0.20 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Percentage A1C (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -1.01 |
| Ertugliflozin 15 mg | -0.92 |
| Placebo | -0.24 |
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -2.95 |
| Ertugliflozin 15 mg | -3.18 |
| Placebo | -1.17 |
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -3.11 |
| Ertugliflozin 15 mg | -3.38 |
| Placebo | -1.33 |
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -37.09 |
| Ertugliflozin 15 mg | -34.47 |
| Placebo | -6.69 |
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -39.01 |
| Ertugliflozin 15 mg | -36.67 |
| Placebo | -10.46 |
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -2.38 |
| Ertugliflozin 15 mg | -2.36 |
| Placebo | -0.96 |
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -2.82 |
| Ertugliflozin 15 mg | -2.77 |
| Placebo | -1.82 |
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -5.09 |
| Ertugliflozin 15 mg | -3.87 |
| Placebo | 0.22 |
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -5.64 |
| Ertugliflozin 15 mg | -4.19 |
| Placebo | -1.56 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 91.49 |
| Ertugliflozin 15 mg | 277.60 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 8.18 |
| Ertugliflozin 15 mg | 27.11 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 91.40 |
| Ertugliflozin 15 mg | 274.23 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 6.59 |
| Ertugliflozin 15 mg | 17.54 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 26: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.34 |
| Ertugliflozin 15 mg | 26.66 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 6: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 9.17 |
| Ertugliflozin 15 mg | 24.59 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 97.36 |
| Ertugliflozin 15 mg | 294.49 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.40 |
| Ertugliflozin 15 mg | 23.84 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 94.82 |
| Ertugliflozin 15 mg | 285.28 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 6.30 |
| Ertugliflozin 15 mg | 17.07 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 26: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.26 |
| Ertugliflozin 15 mg | 24.91 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 6: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.88 |
| Ertugliflozin 15 mg | 22.29 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 26 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 1.2 |
| Ertugliflozin 15 mg | 0.6 |
| Placebo | 1.8 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 26 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 0.7 |
| Ertugliflozin 15 mg | 0.7 |
| Placebo | 2.2 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 28 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 56.5 |
| Ertugliflozin 15 mg | 53.3 |
| Placebo | 59.3 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 28 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 54.4 |
| Ertugliflozin 15 mg | 50.4 |
| Placebo | 59.3 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 0.0 |
| Ertugliflozin 15 mg | 0.7 |
| Placebo | 9.6 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 1.2 |
| Ertugliflozin 15 mg | 0.6 |
| Placebo | 9.6 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 14.7 |
| Ertugliflozin 15 mg | 15.4 |
| Placebo | 2.4 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 14.7 |
| Ertugliflozin 15 mg | 17.0 |
| Placebo | 3.0 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 38.2 |
| Ertugliflozin 15 mg | 40.8 |
| Placebo | 16.2 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 35.3 |
| Ertugliflozin 15 mg | 42.2 |
| Placebo | 18.5 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Up to 183 days
| Intervention | Days (Median) |
|---|---|
| Ertugliflozin 5 mg | NA |
| Ertugliflozin 15 mg | NA |
| Placebo | NA |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Up to 149 days
| Intervention | Days (Median) |
|---|---|
| Ertugliflozin 15 mg | NA |
| Placebo | NA |
Disposition index was measured by multiplying the insulin secretion (C-peptide AUC/C-peptide AUC glucose) by the Matsuda index. Disposition index reflects the beta-cell function adjusted for total body insulin sensitivity (NCT00232583)
Timeframe: 72 months
| Intervention | index (Mean) |
|---|---|
| Metfomin & Insulin | 0.12 |
| Metfomin, Pioglitazone & Glyburide | 0.16 |
C-peptide AUC during a 3-hours mixed meal challenge testing (NCT00232583)
Timeframe: 72 months
| Intervention | ng*min/mL (Mean) |
|---|---|
| Metformin & Insulin | 2096 |
| Metformin, GLyburide & Pioglitazone | 1725 |
Inflammatory markers - hsCRP (C reactive protein) (NCT00232583)
Timeframe: 72 months
| Intervention | mg/L (Mean) |
|---|---|
| Metfomin & Insulin | 6.9 |
| Metfomin, Pioglitazone & Glyburide | 6.1 |
Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1) (NCT00232583)
Timeframe: 72 months
| Intervention | IU/L (Mean) |
|---|---|
| Metfomin & Insulin | 13.9 |
| Metfomin, Pioglitazone & Glyburide | 16.7 |
Inflammatory markers - Fibrinogen (NCT00232583)
Timeframe: 72 months
| Intervention | mg/dL (Mean) |
|---|---|
| Metfomin & Insulin | 399.0 |
| Metfomin, Pioglitazone & Glyburide | 395.4 |
C-peptide-based Matsuda index using following formula: Matsuda index = 500,00 / root square [(fasting c-peptide x fasting glucose x 333) x (average c-peptide 0-120 mins x average glucose 0-120 mins x 333). Higher the Matsuda index, better the insulin sensitivity. (NCT00232583)
Timeframe: 72 months
| Intervention | index (Mean) |
|---|---|
| Metfomin & Insulin | 3.12 |
| Metfomin, Pioglitazone & Glyburide | 2.45 |
Current health perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 2.7 |
| Metfomin, Pioglitazone & Glyburide | 2.9 |
Glycemia control perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 2.8 |
| Metfomin, Pioglitazone & Glyburide | 2.0 |
Hypoglycemia fear was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 1.8 |
| Metfomin, Pioglitazone & Glyburide | 1.8 |
Lifestyle flexibility was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 2.1 |
| Metfomin, Pioglitazone & Glyburide | 2.0 |
Satisfaction with insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 1.2 |
Social or vocational worry was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 1.8 |
| Metfomin, Pioglitazone & Glyburide | 1.7 |
Social stigma was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1- strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 2.2 |
| Metfomin, Pioglitazone & Glyburide | 2.2 |
Treatment impact was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a sale (Mean) |
|---|---|
| Metfomin & Insulin | 1.7 |
| Metfomin, Pioglitazone & Glyburide | 1.8 |
Treatment satisfaction was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 1.7 |
| Metfomin, Pioglitazone & Glyburide | 2.1 |
Willingness to continue insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing. (NCT00232583)
Timeframe: 72 months
| Intervention | score on a scale (Mean) |
|---|---|
| Metfomin & Insulin | 1.4 |
Body Weight (NCT00232583)
Timeframe: 72 months
| Intervention | kg (Mean) |
|---|---|
| Metfomin and Insulin | 107.7 |
| Metformin, Pioglitazone and Glyburide | 107.9 |
12 reviews available for metformin and Adverse Drug Event
| Article | Year |
|---|---|
Update on metformin safety in pregnancy.
Topics: Drug-Related Side Effects and Adverse Reactions; Female; Government Agencies; Humans; Metformin; Pre | 2022 |
Metformin counters oxidative stress and mitigates adverse effects of radiation exposure: An overview.
Topics: Antioxidants; Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adverse Reactions; Humans; Me | 2023 |
Metformin derivatives - Researchers' friends or foes?
Topics: Drug Discovery; Drug-Related Side Effects and Adverse Reactions; Humans; Metformin | 2023 |
Identification of Novel Intronic SNPs in Transporter Genes Associated with Metformin Side Effects.
Topics: Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Introns; | 2023 |
Interaction between drugs and the gut microbiome.
Topics: Animals; Antineoplastic Agents, Immunological; Drug-Related Side Effects and Adverse Reactions; Gast | 2020 |
Psychological distress among health care professionals of the three COVID-19 most affected Regions in Cameroon: Prevalence and associated factors.
Topics: 3' Untranslated Regions; 5'-Nucleotidase; A549 Cells; Accidental Falls; Acetylcholinesterase; Acryli | 2021 |
The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis.
Topics: Drug Synergism; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Female; | 2022 |
Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.
Topics: Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adverse Reactions | 2016 |
Minimizing weight gain for patients taking antipsychotic medications: The potential role for early use of metformin.
Topics: Antipsychotic Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Hypoglycemic Agents; | 2017 |
Combination of Metformin and Lifestyle Intervention for Antipsychotic-Related Weight Gain: A Meta-Analysis of Randomized Controlled Trials.
Topics: Adolescent; Adult; Aged; Antipsychotic Agents; Combined Modality Therapy; Drug-Related Side Effects | 2019 |
Metformin as a protective agent against natural or chemical toxicities: a comprehensive review on drug repositioning.
Topics: Diabetes Mellitus, Type 2; Drug Repositioning; Drug-Related Side Effects and Adverse Reactions; Huma | 2020 |
Pharmacogenomics in diabetes mellitus: insights into drug action and drug discovery.
Topics: Chemical and Drug Induced Liver Injury; Diabetes Mellitus, Type 2; Drug Discovery; Drug-Related Side | 2016 |
7 trials available for metformin and Adverse Drug Event
| Article | Year |
|---|---|
A phase I delayed-start, randomized and pharmacodynamic study of metformin and chemotherapy in patients with solid tumors.
Topics: Adolescent; Adult; Aged; AMP-Activated Protein Kinases; Antineoplastic Combined Chemotherapy Protoco | 2019 |
Psychological distress among health care professionals of the three COVID-19 most affected Regions in Cameroon: Prevalence and associated factors.
Topics: 3' Untranslated Regions; 5'-Nucleotidase; A549 Cells; Accidental Falls; Acetylcholinesterase; Acryli | 2021 |
Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia.
Topics: Aged; Asia, Eastern; Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type 2; Drug-Relate | 2019 |
Phosphodiesterase 4 inhibition as a potential new therapeutic target in obese women with polycystic ovary syndrome.
Topics: Adult; Aminopyridines; Benzamides; Body Weight; Cyclopropanes; Drug-Related Side Effects and Adverse | 2014 |
Metformin prevents metabolic side effects during systemic glucocorticoid treatment.
Topics: Adult; Aged; Anti-Inflammatory Agents; Blood Glucose; Double-Blind Method; Drug-Related Side Effects | 2017 |
Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
Topics: Adamantane; Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administra | 2009 |
Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
Topics: Adamantane; Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administra | 2009 |
Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
Topics: Adamantane; Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administra | 2009 |
Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
Topics: Adamantane; Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administra | 2009 |
Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted.
Topics: Adult; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Drug-Related Side Effects and Adverse R | 2007 |
31 other studies available for metformin and Adverse Drug Event
| Article | Year |
|---|---|
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Topics: Adverse Drug Reaction Reporting Systems; Artificial Intelligence; Computers; Databases, Factual; Dru | 2004 |
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da | 2011 |
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily | 2013 |
Metformin-based single pill drug combinations for type 2 diabetes in primary care England: A time trend analysis.
Topics: Diabetes Mellitus, Type 2; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Human | 2022 |
Evaluation of Metformin Hydrochloride Tailoring Bilosomes as an Effective Transdermal Nanocarrier.
Topics: Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adverse Reactions; Excipients; Humans; Metf | 2022 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
Identification of polypharmacy patterns in new-users of metformin using the Apriori algorithm: A novel framework for investigating concomitant drug utilization through association rule mining.
Topics: Adolescent; Adult; Cohort Studies; Data Mining; Diabetes Mellitus, Type 2; Drug Interactions; Drug U | 2023 |
Lactic acidosis and multisystem organ failure following ibuprofen overdose requiring haemodialysis.
Topics: Acidosis, Lactic; Drug Overdose; Drug-Related Side Effects and Adverse Reactions; Humans; Hypoglycem | 2023 |
Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Female; Hu | 2020 |
Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and All-Cause Mortality for Widely Used Antihyperglycemic Dual and Triple Therapies for Type 2 Diabetes Management: A Cohort Study of All Danish Users.
Topics: Aged; Cardiovascular Diseases; Cause of Death; Cohort Studies; Denmark; Diabetes Mellitus, Type 2; D | 2020 |
Identification of longevity compounds with minimized probabilities of side effects.
Topics: Aging; Animals; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Glucosamine; Hu | 2020 |
'Doctor, will this medicine give me cancer?': Lessons from nitrosamines and extended-release metformin.
Topics: Delayed-Action Preparations; Diabetes Mellitus, Type 2; Drug Industry; Drug-Related Side Effects and | 2021 |
Risk of acute kidney injury and survival in patients treated with Metformin: an observational cohort study.
Topics: Acidosis, Lactic; Acute Kidney Injury; Age Distribution; Aged; Cohort Studies; Comorbidity; Diabetes | 2017 |
Evaluation of the concurrent use of dolutegravir and metformin in human immunodeficiency virus-infected patients.
Topics: Adult; Aged; CD4 Lymphocyte Count; Creatinine; Drug-Related Side Effects and Adverse Reactions; Fema | 2017 |
Study of adverse drug reactions in patients with diabetes attending a tertiary care hospital in New Delhi, India.
Topics: Adult; Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adverse Reactions; Endocrine System; | 2017 |
Risk of lactic acidosis in type 2 diabetes patients using metformin: A case control study.
Topics: Acidosis, Lactic; Aged; Aged, 80 and over; Case-Control Studies; Comorbidity; Denmark; Diabetes Mell | 2018 |
An Evidence Based Study on Comparison of Adverse Drug Reactions of Metformin & Sitagliptin with their Combination.
Topics: Diabetes Mellitus, Type 2; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Evide | 2016 |
Complex decisions in the use of extracorporeal treatments in acute metformin overdose: which modality, when and how to measure the effect.
Topics: Drug Overdose; Drug-Related Side Effects and Adverse Reactions; Humans; Hypoglycemic Agents; Metform | 2018 |
Metformin-associated lactic acidosis precipitated by liraglutide use: adverse effects of aggressive antihyperglycaemic therapy.
Topics: Acidosis, Lactic; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adve | 2018 |
A 35-Year-Old Woman With Shock, Pulseless Electrical Activity Arrest, and Hemodynamic Collapse.
Topics: Abdominal Pain; Acidosis, Lactic; Adult; Diabetes Mellitus, Type 2; Diagnosis, Differential; Drug-Re | 2019 |
Prescription-medication sharing among family members: an unrecognized cause of a serious drug adverse event in a patient with impaired renal function.
Topics: Acidosis, Lactic; Aged; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Drug-Related Side Effects | 2015 |
Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry.
Topics: Adamantane; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Utilization; Drug-Rela | 2014 |
Retrospective evaluation of potentially inappropriate prescribing in hospitalized patients with renal impairment.
Topics: Aged; Aged, 80 and over; Australia; Drug-Related Side Effects and Adverse Reactions; Female; Hospita | 2015 |
Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands.
Topics: Adolescent; Aged; Aged, 80 and over; Child; Drug-Related Side Effects and Adverse Reactions; Female; | 2016 |
The association between use of metformin and change in serum CO2 level after administration of contrast medium.
Topics: Acidosis; Administration, Oral; Aged; Carbon Dioxide; Comorbidity; Contrast Media; Creatinine; Dose- | 2016 |
Association between vitamin B12 levels and mortality in hospitalized older adults.
Topics: Aged; Aged, 80 and over; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions; F | 2010 |
[Discharge letter with therapeutic recommendations: you have to sort out!].
Topics: Antihypertensive Agents; Drug Therapy; Drug Therapy, Combination; Drug-Related Side Effects and Adve | 2010 |
Changes in labelling for metformin use in patients with type 2 diabetes and heart failure: documented safety outweighs theoretical risks.
Topics: Diabetes Mellitus, Type 2; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Heart Fai | 2011 |
Multiple cerebral infarctions related to famotidine-induced eosinophilia.
Topics: Acarbose; Adrenergic alpha-1 Receptor Antagonists; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulc | 2012 |
STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation.
Topics: Abbreviations as Topic; Age Factors; Aged; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Aspi | 2008 |
STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation.
Topics: Abbreviations as Topic; Age Factors; Aged; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Aspi | 2008 |
STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation.
Topics: Abbreviations as Topic; Age Factors; Aged; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Aspi | 2008 |
STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation.
Topics: Abbreviations as Topic; Age Factors; Aged; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Aspi | 2008 |
Metformin-induced lactic acidosis and acute pancreatitis precipitated by diuretic, celecoxib, and candesartan-associated acute kidney dysfunction.
Topics: Acidosis, Lactic; Acute Disease; Acute Kidney Injury; Angiotensin II Type 1 Receptor Blockers; Benzi | 2008 |