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PMID34659110  : Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus.

Abstract

Objectives This study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM). Methods This randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared. Results There were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group. Conclusions Metformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.

Structured Findings

Dulening metformin SR tablets and Glucophage metformin tablets had no significant difference on HbA1c levels, FBG and weight loss after 12-week treatment

Dulening metformin SR tablets significantly decreased Overall incidence of adverse drug reactions (ADRs) compared to Glucophage metformin tablets

Structured Markup

Intervention	Comparator	Outcome	Label
Dulening metformin SR tablets	Glucophage metformin tablets	HbA1c levels, FBG and weight loss after 12-week treatment	no significant difference
Dulening metformin SR tablets	Glucophage metformin tablets	Overall incidence of adverse drug reactions (ADRs)	significantly decreased

PMID22111045  : Comparison of vildagliptin-metformin and glimepiride-metformin treatments in type 2 diabetic patients.

Abstract

BACKGROUND The present study investigated the efficacy and safety of vildagliptin-metformin treatment compared to those of glimepiride-metformin treatment for type 2 diabetes. METHODS In a randomized, open-label, comparative study, 106 patients with type 2 diabetes were enrolled. The primary endpoint was a reduction in HbA1c from baseline and secondary endpoints included fasting plasma glucose (FPG) or 2-hour postprandial glucose (2h-PPG) reduction from baseline, as well as HbA1c responder rate and HbA1c reduction according to baseline HbA1c category. RESULTS Comparable HbA1c reduction was observed with a mean±standard deviation change from baseline to the 32-week endpoint of -0.94±1.15% in the vildagliptin group and -1.00±1.32% in the glimepiride group. A similar reduction in 2h-PPG (vildagliptin group 3.53±4.11 mmol/L vs. the glimepiride group 3.72±4.17 mmol/L) was demonstrated, and the decrements in FPG (vildagliptin group 1.54±2.41 mmol/L vs. glimepiride group 2.16±2.51 mmol/L) were not different between groups. The proportion of patients who achieved an HbA1c less than 7% at week 32 was 50.1% in the vildagliptin group and 56.0% in the glimepiride group. An average body weight gain of 2.53±1.21 kg in the glimepiride group was observed in contrast with the 0.23±0.69 kg weight gain noted in the vildagliptin group. A 10-fold lower incidence of hypoglycemia was demonstrated in the vildagliptin group, in addition to an absence of severe hypoglycemia. CONCLUSION Vildagliptin-metformin treatment provided blood glucose control efficacy comparable to that of glimepiride-metformin treatment and resulted in better adverse event profiles with lower risks of hypoglycemia and weight gain.

Structured Findings

vildagliptin-metformin and glimepiride-metformin had no significant difference on 2h-PPG

vildagliptin-metformin and glimepiride-metformin had no significant difference on HbA1c

Structured Markup

Intervention	Comparator	Outcome	Label
vildagliptin-metformin	glimepiride-metformin	2h-PPG	no significant difference
vildagliptin-metformin	glimepiride-metformin	HbA1c	no significant difference

PMID22192246  : Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage.

Abstract

AIM To investigate whether patients taking metformin for type 2 diabetes mellitus (T2DM) have improved glycaemic control without compromising tolerability by adding an agent with a complementary mechanism of action vs. uptitrating metformin. METHODS Adults with T2DM and glycated haemoglobin (HbA1c) between 7.0 and 10.5% receiving metformin extended release (XR) 1500 mg/day for ≥8 weeks were randomized to receive saxagliptin 5 mg added to metformin XR 1500 mg (n = 138) or metformin XR uptitrated to 2000 mg/day (n = 144). Endpoints were change from baseline to week 18 in HbA1c (primary), 120-min postprandial glucose (PPG), fasting plasma glucose (FPG) and the proportion of patients achieving HbA1c <7%. RESULTS At week 18, the adjusted mean reduction from baseline HbA1c was -0.88% for saxagliptin + metformin XR and -0.35% for uptitrated metformin XR (difference, -0.52%; p < 0.0001). For 120-min PPG and FPG, differences in adjusted mean change from baseline between saxagliptin + metformin XR and uptitrated metformin XR were -1.3 mmol/l (-23.32 mg/dl) (p = 0.0013) and -0.73 mmol/l (-13.18 mg/dl) (p = 0.0030), respectively. More patients achieved HbA1c <7.0% with saxagliptin + metformin XR than with uptitrated metformin XR (37.2 vs. 26.1%; p = 0.0459). The proportions of patients experiencing any adverse events (AEs) were generally similar between groups; neither group showed any notable difference in hypoglycaemia or gastrointestinal AEs. CONCLUSION Adding saxagliptin to metformin XR provided superior glycaemic control compared with uptitrating metformin XR without the emergence of additional safety concerns.

Structured Findings

saxagliptin 5 mg added to metformin XR 1500 mg significantly decreased HbA1c 7.0% compared to metformin XR uptitrated to 2000 mg/day

saxagliptin 5 mg added to metformin XR 1500 mg significantly decreased 120-min postprandial glucose (PPG) compared to metformin XR uptitrated to 2000 mg/day

Structured Markup

Intervention	Comparator	Outcome	Label
saxagliptin 5 mg added to metformin XR 1500 mg	metformin XR uptitrated to 2000 mg/day	HbA1c 7.0%	significantly decreased
saxagliptin 5 mg added to metformin XR 1500 mg	metformin XR uptitrated to 2000 mg/day	120-min postprandial glucose (PPG)	significantly decreased