Initial treatment with rosiglitazone/metformin fixed‐dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes

Rosenstock, Julio; Rood, Julie A.; Cobitz, Alexander R.; Biswas, Nandita; Chou, Hubert S.; Garber, Alan J.

doi:10.1111/j.1463-1326.2006.00659.x

Cited by 79 publications

(79 citation statements)

References 29 publications

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“…This observation (14,15,(25)(26)(27), although such differences could be explained by differences in study design or patient populations studied. Since the extent of glucose lowering is generally closely related to the pretreatment glucose levels, the lack of additivity for most other initial combination treatments is likely explained by the effect of one agent attenuating the extent of response to the other agent.…”

Section: Safety and Tolerabilitymentioning

confidence: 90%

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Effect of Initial Combination Therapy With Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients With Type 2 Diabetes

et al. 2007

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OBJECTIVE—To assess the efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes and inadequate glycemic control on diet and exercise. RESEARCH DESIGN AND METHODS—In a 24-week, randomized, double-blind, placebo-controlled, parallel-group study, 1,091 patients with type 2 diabetes and A1C 7.5–11% were randomized to one of six daily treatments: sitagliptin 100 mg/metformin 1,000 mg (S100/M1000 group), sitagliptin 100 mg/metformin 2,000 mg (S100/M2000 group), metformin 1,000 mg (M1000 group), metformin 2,000 mg (M2000 group) (all as divided doses administered twice daily [b.i.d.]), sitagliptin 100 mg q.d. (S100 group), or placebo. Patients who had an A1C >11% or a fasting glucose value >280 mg/dl after the run-in period were not eligible to be randomized; these patients could participate in an open-label substudy and were treated with S100/M2000 for 24 weeks. RESULTS—The mean baseline A1C was 8.8% in the randomized patients. The placebo-subtracted A1C change from baseline was −2.07% (S100/M2000), −1.57% (S100/M1000), −1.30% (M2000), −0.99% (M1000), and −0.83% (S100) (P < 0.001 for comparisons versus placebo and for coadministration versus respective monotherapies). The proportion of patients achieving an A1C <7% and <6.5% was 66 and 44%, respectively, in the S100/M2000 group (P < 0.001 vs. S100 or M2000). For the open-label cohort (n = 117; baseline A1C 11.2%) treated with S100/M2000, the within-group mean A1C change from baseline was −2.9%. The incidence of hypoglycemia was low (0.5–2.2%) across active treatment groups and not significantly different from that in the placebo group (0.6%). The incidence of gastrointestinal adverse experiences was similar for coadministration therapies compared with their respective metformin monotherapy. CONCLUSIONS—The initial combination of sitagliptin and metformin provided substantial and additive glycemic improvement and was generally well tolerated in patients with type 2 diabetes.

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Section: Safety and Tolerabilitymentioning

confidence: 90%

“…Of the available therapies, metformin is the most commonly used oral antihyperglycemic agent (OHA), both as mono- therapy and in combination with other agents such as sulfonylureas or thiazolidinediones (13)(14)(15)(16). Metformin reduces elevated blood glucose levels by reducing hepatic glucose output and also by improving insulin resistance (17).…”

mentioning

confidence: 99%

Effect of Initial Combination Therapy With Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients With Type 2 Diabetes

et al. 2007

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“…The rationale for the combination therapy with metformin and rosiglitazone or pioglitazone would be the fact that these drugs, despite being insulin sensitizers, target insulin resistance through different and complementary mechanisms (34,35). Indeed, whereas metformin has a stronger effect to suppress hepatic glucose output, TZDs have a stronger effect to increase peripheral glucose disposal (27,34,35). However, this therapy does not directly increase insulin secretion that is impaired in type 2 diabetes (3,26).…”

Section: Discussionmentioning

confidence: 99%

“…Different regimens have been proposed, but the most commonly used is metformin combined with a sulphonylurea (26,32,33). The rationale for the combination therapy with metformin and rosiglitazone or pioglitazone would be the fact that these drugs, despite being insulin sensitizers, target insulin resistance through different and complementary mechanisms (34,35). Indeed, whereas metformin has a stronger effect to suppress hepatic glucose output, TZDs have a stronger effect to increase peripheral glucose disposal (27,34,35).…”

Section: Discussionmentioning

confidence: 99%

Comparison of metformin, gliclazide MR and rosiglitazone in monotherapy and in combination for type 2 diabetes

Vilar

Canadas

Arruda

et al. 2010

Arq Bras Endocrinol Metab

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Objective: To compare the efficacy and tolerability of metformin, rosiglitazone and gliclazide MR as monotherapy and in combination in the treatment of type 2 diabetes. Subjects and methods: 250 patients treated with oral antidiabetic agents for at least 24 weeks in monotherapy or in combination therapy were included in this retrospective study. Results: As monotherapy the reduction of fasting plasma glucose (FPG), postprandial glycemia (PPG) and HbA1c was similar with the three drugs after 24 weeks. Among patients on combination therapy, the reduction in HbA1c, FPG and PPG was significantly lower with rosiglitazone plus metformin, as compared to metformin plus gliclazide MR or gliclazide MR plus rosiglitazone. Patients treated with rosiglitazone achieved less favorable changes in lipid profile. Conclusion: In monotherapy all drugs were equally effective in improving glycemic control, whereas the combination of metformin plus gliclazide MR provided the best results concerning the improvement of both, glycemic control and lipid profile. Arq Bras Endocrinol Metab. 2010;54(3):311-8 Keywords Metformin; glicazide MR; rosiglitazone RESUMO Objetivo: Comparar a eficácia e a tolerabilidade da metformina, rosiglitazona e gliclazida MR em monoterapia ou em combinação no tratamento do diabetes tipo 2. Sujeitos e métodos: 250 pacientes tratados com antidiabéticos orais por pelo menos 24 semanas, em monoterapia ou em terapia combinada, foram incluídos neste estudo retrospectivo. Resultados: Como monoterapia, a redução da glicemia de jejum (GJ), glicemia pós-prandial (GPP) e HbA1c foi similar com as três drogas, após 24 semanas. Entre os pacientes em terapia combinada, a redução da HbA1c, GJ e GPP foi significativamente menor com rosiglitazona e metformina, em comparação com metformina e gliclazida MR ou gliclazida MR mais rosiglitazona. Os pacientes tratados com rosiglitazona obtiveram mudanças menos favoráveis no perfil lipídico. Conclusão: Em monoterapia todos os medicamentos foram igualmente eficazes na melhora do controle glicêmico, enquanto a combinação de metformina e gliclazida MR proporcionou os melhores resultados relativos à melhoria de ambos, controle glicêmico e perfil lipídico. Arq Bras Endocrinol Metab. 2010;54(3):311-8

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“…In a 2-year study of glyburide versus nateglinide in combination with metformin, A1C fell similarly from 8.3 to 6.8 vs. 6.9%, with hypoglycemia prevalence 18 vs. 8% (14). The combination of rosiglitazone with metformin in mean doses of 7 and 1,800 mg daily, respectively, led to a 2.3% fall in A1C, while 8 mg rosiglitazone daily led to a 1.6% fall and 1,847 mg metformin daily to a 1.8% fall in A1C from baseline levels of 8.8% (15). Rosiglitazone increased adiponectin, with potential for anti-inflammatory and anti-atherosclerotic benefit, but was associated with more edema, while metformin led to more gastrointestinal side effects.…”

mentioning

confidence: 99%

Exploring Treatment Strategies for Type 2 Diabetes

Bloomgarden

2007

Diabetes Care

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Initial treatment with rosiglitazone/metformin fixed‐dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes

Cited by 79 publications

References 29 publications

Effect of Initial Combination Therapy With Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients With Type 2 Diabetes

Effect of Initial Combination Therapy With Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients With Type 2 Diabetes

Comparison of metformin, gliclazide MR and rosiglitazone in monotherapy and in combination for type 2 diabetes

Exploring Treatment Strategies for Type 2 Diabetes

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