Combination Therapy With Nateglinide and a Thiazolidinedione Improves Glycemic Control in Type 2 Diabetes

Rosenstock, Julio; Shen, Sharen G.; Gatlin, Marjorie; Foley, James E.

doi:10.2337/diacare.25.9.1529

Cited by 45 publications

(29 citation statements)

References 22 publications

(25 reference statements)

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“…since hypoglycemic symptoms also showed no major difference of incidence among the groups, combination therapy did not increase the risk of onset of such side effects. in combination therapy with insulinotropic sur ligands and thiazolidinedione derivatives, weight gains of about 2-6 kg from baseline have been reported [16][17][18]. A slight weight gain observed in the present study was not a clinical problem, even though weight control is considered necessary with long-term combination therapy with the two drugs tested.…”

Section: Safetysupporting

confidence: 45%

Addition of Mitiglinide to Pioglitazone Monotherapy Improves Overall Glycemic Control in Japanese Patients with Type 2 Diabetes: A Randomized Double Blind Trial

et al. 2009

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Abstract. a 16-week, multicenter, randomized, double blind, parallel-group study was performed to examine whether additional administration of mitiglinide improves glycemic control in Japanese type 2 diabetic patients who are insufficiently controlled by pioglitazone monotherapy. Japanese adult type 2 diabetic patients were at first treated with diet plus pioglitazone 15-30 mg/day for 4 weeks then randomized to receive additional mitiglinide 5 or 10 mg or placebo tid for a further 16 weeks. In all, 381 patients were randomized. At final evaluation, glycated hemoglobin (HbA1c) was reduced by (mean ± SD) −0.02 ± 0.60% in the pioglitazone monotherapy group and by −0.45 ± 0.77% and −0.67 ± 0.59% in the mitiglinide 5 and 10 mg combination groups, respectively (both p<0.001 vs. pioglitazone monotherapy group). the percentage of patients who achieved hba 1c targets was significantly (p<0.001) higher in the mitiglinide combination groups than in the pioglitazone monotherapy group. Significant improvements in fasting plasma glucose and postprandial plasma glucose were noted in the mitiglinide combination groups versus the pioglitazone monotherapy group. no increase in adverse events was noted when mitiglinide was administered concomitantly with pioglitazone monotherapy. hypoglycemic adverse events were infrequently and similarly observed in all three groups. Body weight gain and edema presented no clinical problem. hba 1c was significantly improved in the mitiglinide combination groups compared with the pioglitazone monotherapy group, and significantly more patients achieved HbA 1c targets. therefore mitiglinide effectively improves glycemic control in type 2 diabetic patients who are inadequately controlled by pioglitazone monotherapy.

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Section: Safetysupporting

confidence: 45%

Addition of Mitiglinide to Pioglitazone Monotherapy Improves Overall Glycemic Control in Japanese Patients with Type 2 Diabetes: A Randomized Double Blind Trial

et al. 2009

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“…Because there was also no clear difference in the incidence of hypoglycemic symptoms among the groups, combination therapy did not increase the risk of onset of hypoglycemia. Although in combination therapy with insulinotropic SUR ligands and thiazolidinedione derivatives, weight gains of about 2-6 kg from baseline have been reported in patients with normal kidney function [17][18][19], we found no significant changes in the dry weight even in patients treated combined with pioglitazone. In contrast, interdialytic weight gain was significantly reduced at the end of the study compared with baseline.…”

Section: Discussioncontrasting

confidence: 78%

Efficacy and safety of mitiglinide in diabetic patients on maintenance hemodialysis

et al. 2010

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Numerous drugs with different mechanisms of action are being used with the aim of improving glycemic control, and drugs with different pharmacologic profiles are employed in the management of type 2 diabetes. Therapeutic options for patients with type 2 diabetes and end-stage renal disease (ESRD) are limited because a reduced glomerular filtration rate results in the accumulation of certain drugs and/or their metabolites [1]. Conventional oral hypoglycemic agents, such as sulfonylurea (SU), are not suitable due to the risk of prolonged hypoglycemia; furthermore, metformin is contraindicated. Therefore, in order to achieve good glycemic control, insulin injection therapy remains the mainstay of treatment in diabetic pa- Abstract. Mitiglinide is a rapid-and short-acting insulinotropic sulfonylurea receptor ligand and features rapid hypoglycemic action. To date, no prospective study has evaluated the use of mitiglinide in diabetic patients receiving hemodialysis (HD). In this study we evaluated the efficacy and safety of mitiglinide in diabetic patients on HD. Following an 8-week baseline period, we enrolled a study population of poorly controlled diabetic HD patients who had mean hemoglobin (Hb)A 1c levels greater than 6.5% at baseline and who were not receiving insulin injection therapy. Patients were administered mitiglinide, 15 mg for those who were younger than 70 years and 7.5 mg for those who were 70 years and older, daily with each meal for the first 8 weeks. Subsequently, the doses were titrated by dose-doubling to a maximum of 30 mg/day if no adverse effects appeared. The efficacy was determined by monitoring glycemic control (plasma glucose, HbA 1c , and glycated albumin levels). Safety and tolerance were determined by monitoring clinical and laboratory parameters during the 24-week study period. The average final dose of mitiglinide was 20.0 ± 8.6 mg daily. Mitiglinide was effective in reducing not only HbA 1c and glycated albumin but also fasting plasma glucose levels from week 4 after the start of treatment. The agent was also effective in reducing triglyceride levels. No serious adverse effects such as hypoglycemia or liver impairment were observed in any patient. However, we could not completely rule out the possibility of a hypoglycemic episode, including silent hypoglycemia due to autonomic neuropathy, and therefore further clinical studies are required. It is necessary to adjust the dose of mitiglinide according to the status of glycemic control or hypoglycemic symptoms of individual patients. Although mitiglinide was effective as a treatment for diabetic patients on HD therapy, it should be initiated at a lower dose in the HD population, compared with the general population of diabetic patients. Mitiglinide can be safely used for diabetic patients on HD, if careful attention is paid to hypoglycemia.Key words: Glycemic control, Hemodialysis, Mitiglinide, Type-2 diabetes tients receiving hemodialysis (HD) therapy.Mitiglinide is a rapid-and short-acting insulinotropic SU receptor (SUR) ligand, whic...

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“…The efficacy was similar to or slightly better than that observed in the overall population of the separate studies (16,18,22). It is known that glucose values increase with age, with prandial (postload) glucose levels increasing more than fasting levels (ϳ0.83 vs. 0.06 -0.11 mmol/l per decade) (23,26).…”

Section: Hypoglycemiasupporting

confidence: 66%

“…Three of these studies are published (16,18,22). Comparative efficacy analyses with metformin and glyburide were not performed, as most patients on comparative treatments had achieved maximal reductions in HbA 1c before study randomization.…”

Section: Efficacy Evaluationmentioning

confidence: 99%

Treatment of Patients Over 64 Years of Age With Type 2 Diabetes

et al. 2003

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OBJECTIVE -To evaluate the impact of renal impairment (RI) (estimated creatinine clearance [Cl cr ] Ͻ60 ml/min per 1.73 m 2 ) and low baseline HbA 1c (Ͻ7.5%) on comorbidity in patients with type 2 diabetes, and to assess the efficacy and safety of nateglinide monotherapy in these patients and in subgroups of patients over age 64 years (elderly) and elderly with RI.RESEARCH DESIGN AND METHODS -Retrospective subgroup analyses were performed on pooled data from all completed nateglinide studies (12 randomized, double blind trials and 1 open trial) in patients with type 2 diabetes. A total of 3,702 patients with Ն1 postbaseline safety evaluation received monotherapy with nateglinide (n ϭ 2,204), metformin (n ϭ 436), glyburide (n ϭ 293), or placebo (n ϭ 769). Efficacy (HbA 1c ) was evaluated in pooled data from four studies with similar design using 120 mg nateglinide (n ϭ 544) versus placebo (n ϭ 521). Evaluations were performed in the overall population and subgroups of patients over age 64 years. Specific considerations were given to RI, comorbidity, and baseline HbA 1c .RESULTS -Patients over age 64 years (n ϭ 1,170) represented 31.6% of the study population. Undiagnosed RI was common in the elderly with 83.4% of all patients being in this subgroup. Patients over 64 years with RI had a higher prevalence of cardio-and microvascular comorbidity compared with the overall population and all patients over age 64 years. Statistically significant HbA 1c reductions versus placebo were observed with nateglinide in patients over age 64 years and elderly with RI patients at study end point (Ϫ0.9% and Ϫ1.1% in each subgroup, P Ͻ 0.01). Nateglinide was well tolerated with a low incidence of hypoglycemia in all subgroups, including those with RI and low baseline HbA 1c .CONCLUSIONS -RI and comorbidity are common in patients over age 64 years with type 2 diabetes. Nateglinide was effective and well tolerated in all treated patients. In subgroups in which metformin and long-acting sulfonylureas must be used with caution, nateglinide had a low risk of adverse events and hypoglycemia. Diabetes Care 26:2075-2080, 2003T he highest prevalence of type 2 diabetes in the U.S. is observed in the elderly population, with a projected prevalence of 13.6% in men and 14.7% in women aged 65-74 years (1). The therapeutic principles of managing type 2 diabetes in the elderly are no different from those in younger patients, but the strategies need to be cautiously individualized. Comorbid conditions are common in the elderly with type 2 diabetes and frequently influence the choice and intensity of treatment. Treatment to target with current antihyperglycemic agents is often not attempted because of the risk of severe hypoglycemia and possible exacerbation of cognitive deficiencies or coexisting cardiovascular conditions (2-6).Most oral blood glucose-lowering agents must be used with caution in patients with renal impairment (RI) or in the presence of comorbidity. RI has long been recognized to be common in the elderly, but its prevalence has not ...

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Combination Therapy With Nateglinide and a Thiazolidinedione Improves Glycemic Control in Type 2 Diabetes

Cited by 45 publications

References 22 publications

Addition of Mitiglinide to Pioglitazone Monotherapy Improves Overall Glycemic Control in Japanese Patients with Type 2 Diabetes: A Randomized Double Blind Trial

Addition of Mitiglinide to Pioglitazone Monotherapy Improves Overall Glycemic Control in Japanese Patients with Type 2 Diabetes: A Randomized Double Blind Trial

Efficacy and safety of mitiglinide in diabetic patients on maintenance hemodialysis

Treatment of Patients Over 64 Years of Age With Type 2 Diabetes

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