Beauty Products : B  C  D  E  F  G  I  N  P  R  S

In addition, this study included patients (N=117) with more severe hyperglycemia (HbA_1c >11% or blood glucose >280 mg/dL) who were treated with open-label sitagliptin at 50 mg and metformin at 1000 mg twice daily. In this group of patients, the baseline HbA_1c value was 11.15%, FPG was 314.4 mg/dL, and 2-hr PPG was 441 mg/dL. After 24 weeks, decreases from baseline of -2.94% for HbA_1c, -126.7 mg/dL for FPG, and -207.9 mg/dL for 2-hr PPG were observed. In this open-label cohort, a modest increase in body weight of 1.3 kg was observed at 24 weeks.

Sitagliptin Add-on Therapy in Patients Inadequately Controlled on Metformin Alone: The combination of sitagliptin and metformin has been evaluated for safety and efficacy in 2 double-blind, placebo-controlled clinical studies in patients with type 2 diabetes mellitus. In both studies, patients with inadequate glycemic control on stable doses of metformin ≥1500 mg were randomized to receive either sitagliptin 100 mg/day or placebo in addition to ongoing treatment with metformin.

In 1 study, 701 patients received 100 mg of sitagliptin or placebo once daily for 24 weeks. The addition of sitagliptin to ongoing metformin treatment provided significant improvements compared with the addition of placebo to ongoing metformin treatment in HbA_1c (-0.65%), FPG (-25.4 mg/dL), and 2-hr PPG (-50.6 mg/dL) (see Figure 2 and Table 2). This improvement in HbA_1c compared to placebo was not affected by baseline HbA_1c value, prior antihyperglycemic therapy, gender, age, baseline BMI, length of time since diagnosis of diabetes, presence of metabolic syndrome, or standard indices of insulin resistance (HOMA-IR) or insulin secretion (HOMA-β). Compared to patients taking placebo, patients taking sitagliptin demonstrated slight decreases in total cholesterol, non-HDL cholesterol and triglycerides. A similar decrease in body weight was observed for both treatment groups.

In a separate study, 24-hr plasma glucose values were assessed. Twenty-eight patients received either 50 mg sitagliptin or placebo twice daily for 4 weeks in addition to their twice-daily metformin regimen. Following 4 weeks of treatment, the difference in glucose-lowering efficacy was assessed as a 24-hr weighted mean glucose (WMG) based upon collection of multiple blood samples, including those obtained before and after meals as well as overnight. Sitagliptin 50 mg co-administered twice daily with metformin significantly lowered the 24-hr WMG (-32.8 mg/dL) compared to placebo co-administered with metformin. In addition, sitagliptin administered with metformin, compared with placebo administered with metformin, substantially lowered fasting glucose concentrations and demonstrated smaller glucose excursions after all 3 meals (see Figure 3). In patient-collected glucose measurements, treatment with sitagliptin administered with metformin also provided significant reductions compared to placebo administered with metformin in mean fasting plasma glucose (-20.3 mg/dL), 7-point glucose average (-28 mg/dL), and 2-hr post-glucose concentrations (-36.6 mg/dL). See Figure 3.

Sitagliptin Add-on Therapy in Patients Inadequately Controlled on the Combination of Metformin and Glimepiride: A total of 441 patients with type 2 diabetes participated in a 24-week, randomized, double-blind, placebo-controlled study designed to assess the efficacy of sitagliptin 100 mg once daily compared to placebo in combination with glimepiride (alone or in combination with metformin). In this study, 220 patients were on the combination of glimepiride (≥4 mg/day) and metformin (≥1500 mg/day); the results of the glycemic endpoints, including HbA_1c and FPG, are described in the following text.

The combination of sitagliptin, glimepiride and metformin provided significant reduction from baseline in HbA_1c (-0.89%) and FPG (-20.7 mg/dL) compared to placebo (see Table 3). Mean reductions from baseline in HbA_1c compared with placebo were generally greater for patients with higher baseline HbA_1c values. Patients treated with sitagliptin had a modest increase in body weight compared to those given placebo.  

1    2    3    4    5    6