Sitagliptin/Metformin Fixed-Dose Combination

Chwieduk, Claudine M

doi:10.2165/11206060-000000000-00000

Cited by 22 publications

(7 citation statements)

References 45 publications

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“…Previous randomized clinical studies have shown that sitagliptin monotherapy reduced the glycosylated hemoglobin (HbA 1c ) level by 0.4–0.6% [2–4], and sitagliptin combination therapy with metformin or thiazolidinedione decreased HbA 1c by 0.4–1.4% over 18–52 weeks of treatment in patients with type 2 diabetes (T2D) [3,5,6]. More specifically, the clinical trials with sitagliptin and metformin as initial combination therapy have shown an average reduction of HbA 1c by ≥0.8% [6,7]. …”

Section: Introductionmentioning

confidence: 99%

Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study

Ku¹,

Jung²,

Kim³

et al. 2015

PLoS ONE

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ObjectivesWe investigated the efficacy of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes for 4 years in clinical practice.MethodsBetween 2009 and 2010, we reviewed 1,178 patients with type 2 diabetes (HbA1c ≥7.5% or 58 mmol/mol) prescribed initial combination therapy with sitagliptin and metformin. After excluding 288 patients without a second follow-up, 890 individuals (age, 58.0 ± 12.5 years; BMI, 25.4 ± 3.5 kg/m2; HbA1c, 8.6 ± 1.1%) were followed up with every 3–6 months for 4 years. Homeostasis model assessments for insulin resistance and β-cell function (HOMA-β) were recorded at baseline. The response criterion was HbA1c reduction by ≥0.8% from baseline or attainment of the target HbA1c (≤7.0% or 53 mmol/mol). At the end of every year of treatment, changes in HbA1c from the baseline were assessed.ResultsAfter 1 year, 72.2% of patients with initial combination therapy had responded, defined as HbA1c reduction ≥0.8% or attainment of the target HbA1c ≤7.0%. After 4 years, 35.4% of the patients still showed a response, with an HbA1c level of 7.0 ± 0.9%. A high HbA1c level at baseline was the most significant independent predictor of the long-term response (P<0.001). In addition, low HOMA-β was a significant predictor of a greater reduction in HbA1c. This treatment was generally well tolerated over the 4-year follow-up period, without any serious adverse events.ConclusionsThis real-world follow-up study shows a persistent glucose-reducing effect of initial combination therapy with sitagliptin and metformin for up to 4 years.

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Section: Introductionmentioning

confidence: 99%

Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study

Ku¹,

Jung²,

Kim³

et al. 2015

PLoS ONE

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“…People taking a combination of oral antidiabetic drugs have about 11% higher risk of developing hypoglycemia than people on monotherapy. Dipeptidyl peptidase-4 (DPP-4) inhibitors improve pancreatic islet function by augmenting glucose-dependent insulin secretion and decreasing elevated plasma glucagon levels [2][3][4][5][6]. Not only are they efficacious, they are also safe (weight neutral) and do not cause significant hypoglycemia, making it a unique class of drugs.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Analysis of Oral Antidiabetic Drug by LC-MS/MS

et al. 2015

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Diabetes is one of the most common chronic diseases, and several new oral agents have been approved for type 2 diabetes management in recent years. A combination of different classes of antidiabetic agents is often required to avoid adverse effects such as severe hypoglycemia. A potential novel combination in development involves a fixed dose single-tablet combination of pioglitazone and a dipeptidyl peptidase 4 (DPP-4) inhibitor. DPP-4 inhibitors are a relatively new class of oral antidiabetic drugs. In this study, we simultaneously analyzed eight antidiabetic drugs, including newly developed DPP-4 inhibitors, by high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry (HPLC-ESI-MS/MS). The developed method was applied to analyze the active ingredients in combination drugs and to determine the concentration of antidiabetic drugs in river water. Our results indicate that three recently approved antidiabetic drugs, sitagliptin, alogliptin, and vildagliptin, are present in river water.

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“…The fixed-dose combination of sitagliptin and metformin as add-on therapy (with or without ongoing insulin) has been shown to reduce HbA 1c significantly in patients with type 2 diabetes and inadequate glycemic control 12,13. Long-term safety and tolerability were maintained 14.…”

Section: Discussionmentioning

confidence: 99%

Sitagliptin as add-on therapy in insulin deficiency: biomarkers of therapeutic efficacy respond differently in type 1 and type 2 diabetes

Giampietro¹,

Giampietro²,

Bartola³

et al. 2013

DDDT

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BackgroundSitagliptin has been proven to be effective and safe as add-on to insulin in adult patients with type 2 diabetes and absolute insulin deficiency. Recently, it has been suggested to extend the use of dipeptidyl-peptidase-4 inhibitors to type 1 diabetes. The aim of this study was to evaluate and compare the effects of a long-term, fixed-dose combination of sitagliptin and metformin as add-on to insulin on body mass index, fasting plasma glucose, fructosamine, HbA1c, lipids, and daily dose of insulin in both type 1 diabetes and insulin-treated type 2 diabetes.MethodsWe recruited 25 patients with type 1 diabetes (mean age 51 ± 10 years, mean disease duration 26 ± 13 years) and 31 insulin-treated type 2 diabetic patients (mean age 66 ± 8 years, mean disease duration 19 ± 9 years), who received sitagliptin with metformin as a fixed-dose combination (50/1000 mg once or twice daily) or sitagliptin (100 mg once daily, if intolerant to metformin) in addition to ongoing insulin therapy for 46 ± 19 weeks and 56 ± 14 weeks, respectively.ResultsAfter 21 ± 9 weeks, patients with type 1 diabetes had a significantly lower body mass index, fasting plasma glucose, fructosamine, HbA1c, and daily insulin requirement. After 49 ± 17 weeks, they maintained their weight loss and total daily insulin dose and showed a significant reduction in low-density lipoprotein cholesterol levels, whereas their HbA1c had returned to baseline values. In patients with type 2 diabetes, long-term treatment remained weight-neutral but had persistent beneficial effects on short-term, intermediate-term, and long-term biomarkers of metabolic control, as well as on low-density lipoprotein cholesterol levels and insulin requirement.ConclusionClinical outcomes differed according to type of diabetes in terms of quality and over time. In type 2 diabetes, the combination therapy significantly improved metabolic control and the lipid profile, and decreased insulin requirements, even in the absence of clinically significant weight loss. In type 1 diabetes, the combined therapy only temporarily improved metabolic control, but significantly decreased body weight, low-density lipoprotein cholesterol levels, and insulin requirements.

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Sitagliptin/Metformin Fixed-Dose Combination

Cited by 22 publications

References 45 publications

Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study

Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study

Simultaneous Analysis of Oral Antidiabetic Drug by LC-MS/MS

Sitagliptin as add-on therapy in insulin deficiency: biomarkers of therapeutic efficacy respond differently in type 1 and type 2 diabetes

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