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PMID20444662  : Patient-reported outcomes in patients with type 2 diabetes treated with liraglutide or glimepiride, both as add-on to metformin.

Abstract

Patient-reported outcomes for liraglutide or glimepiride on metformin were investigated. Patients' treatment satisfaction on liraglutide was higher than with metformin alone and comparable with glimepiride+metformin. Patients perceived lower frequency of hypoglycaemia than glimepiride+metformin and lower frequency of hyperglycaemia than metformin. Impact of weight on quality of life did not differ.

Structured Findings

Liraglutide significantly decreased Hypoglycaemia compared to Glimepiride

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Intervention	Comparator	Outcome	Label
Liraglutide	Glimepiride	Hypoglycaemia	significantly decreased

PMID25172519  : Mechanism of increase in plasma intact GLP-1 by metformin in type 2 diabetes: stimulation of GLP-1 secretion or reduction in plasma DPP-4 activity?

Abstract

Metformin was reported to increase plasma intact glucagon-like peptide-1 (GLP-1) concentrations in type 2 diabetes. This is, at least partly, attributable to stimulation of GLP-1 secretion. A reduction in soluble dipeptidyl peptidase-4 activity may also make a modest contribution.

Structured Findings

Metformin significantly increased Intact glucagon-like peptide-1 (GLP-1) concentrations compared to Control

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Intervention	Comparator	Outcome	Label
Metformin	Control	Intact glucagon-like peptide-1 (GLP-1) concentrations	significantly increased

PMID30614289  : Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial.

Abstract

The present study was planned to evaluate the benefit of synergetic effect of Metformin plus Myo-inositol versus Metformin alone in infertile polycystic ovarian syndrome (PCOS) women undergoing ovulation induction. One hundred and twenty infertile PCOS women were randomized: Group I (n = 60) received Metformin (500 mg) plus Myoinositol(600 mg) three times a day; Group II received Metformin 500 mg three times a day. Subjects were advised to try for spontaneous conception. Those who did not conceive after 3 months, were given three cycles of ovulation induction + intrauterine insemination. Hormonal and biochemical profile parameters were done at baseline and after 3 months of therapy. Primary outcome measure was live birth rate. Secondary outcomes were improvement in menstrual cycle, hormonal and biochemical parameters, spontaneous conception, abortions, multiple pregnancy, and ovarian hyperstimulation syndrome. Baseline demographic, hormonal and biochemical parameters were comparable in two groups. There was a significant improvement in menstrual cycles (cycle length and bleeding days) in Group I as compared to Group II. The improvement in biochemical and hormonal parameters were comparable in the two groups after 3 months. Live birth rate was significantly higher in the Group I as compared to Group II [55% (33/60); 26.67% (16/60); p = .002]. The study concluded significantly higher live birth rate in women receiving the combination as compared to metformin alone.

Structured Findings

Metformin (500 mg) plus Myoinositol(600 mg) three times a day significantly increased Living birth rate compared to Metformin 500 mg three times a day

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Intervention	Comparator	Outcome	Label
Metformin (500 mg) plus Myoinositol(600 mg) three times a day	Metformin 500 mg three times a day	Living birth rate	significantly increased

PMID16842480  : Comparison of nateglinide and gliclazide in combination with metformin, for treatment of patients with Type 2 diabetes mellitus inadequately controlled on maximum doses of metformin alone.

Abstract

AIM To compare the effects of nateglinide plus metformin with gliclazide plus metformin on glycaemic control in patients with Type 2 diabetes. METHODS Double-blind, double-dummy, parallel group, randomized, multicentre study over 24 weeks. Patients with inadequate glucose control on maximal doses of metformin were randomized to additionally receive nateglinide (n = 133) or gliclazide (n = 129). Changes from baseline in HbA1c, fasting plasma glucose (FPG) and mealtime glucose and insulin excursions were examined. RESULTS HbA1c was significantly (P < 0.001) decreased from baseline in both treatment groups (mean changes: nateglinide -0.41%, gliclazide -0.57%), but with no significant difference between treatments. Proportions of patients achieving a reduction of HbA1c >or= 0.5% or an end point HbA1c < 7% were also similar (nateglinide 58.1%, gliclazide 60.2%). Changes from baseline in FPG were similarly significant in both treatment groups (nateglinide -0.63, gliclazide -0.82 mmol/l). Reduction from baseline in maximum postprandial glucose excursion were significant in the nateglinide group only (nateglinide -0.71, gliclazide -0.10 mmol/l; P = 0.037 for difference). Postprandial insulin levels were significantly higher with nateglinide compared with gliclazide. The overall rate of hypoglycaemia events was similar in the nateglinide group compared with the gliclazide group. CONCLUSIONS No significant difference was seen between nateglinide plus metformin and gliclazide plus metformin in terms of HbA1c. However, the nateglinide combination demonstrated better postprandial glucose control.

Structured Findings

nateglinide plus metformin and gliclazide plus metformin had no significant difference on HbA1c

nateglinide plus metformin significantly decreased maximum postprandial glucose excursion compared to gliclazide plus metformin

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Intervention	Comparator	Outcome	Label
nateglinide plus metformin	gliclazide plus metformin	HbA1c	no significant difference
nateglinide plus metformin	gliclazide plus metformin	maximum postprandial glucose excursion	significantly decreased

PMID25802471  : Addition of a Gastrointestinal Microbiome Modulator to Metformin Improves Metformin Tolerance and Fasting Glucose Levels.

Abstract

BACKGROUND Adverse effects of metformin are primarily related to gastrointestinal (GI) intolerance that could limit titration to an efficacious dose or cause discontinuation of the medication. Because some metformin side effects may be attributable to shifts in the GI microbiome, we tested whether a GI microbiome modulator (GIMM) used in combination with metformin would ameliorate the GI symptoms. METHODS A 2-period crossover study design was used with 2 treatment sequences, either placebo in period 1 followed by GIMM in period 2 or vice versa. Study periods lasted for 2 weeks, with a 2-week washout period between. During the first week, type 2 diabetes patients (T2D) who experienced metformin GI intolerance took 500 mg metformin along with their assigned NM504 (GIMM) or placebo treatment with breakfast and with dinner. In the second week, the 10 subjects took 500 mg metformin (t.i.d.), with GIMM or placebo consumed with the first and third daily metformin doses. Subjects were permitted to discontinue metformin dosing if it became intolerable. RESULTS The combination of metformin and GIMM treatment produced a significantly better tolerance score to metformin than the placebo combination (6.78 ± 0.65 [mean ± SEM] versus 4.45 ± 0.69, P = .0006). Mean fasting glucose levels were significantly (P < .02) lower with the metformin-GIMM combination (121.3 ± 7.8 mg/dl) than with metformin-placebo (151.9 ± 7.8 mg/dl). CONCLUSION Combining a GI microbiome modulator with metformin might allow the greater use of metformin in T2D patients and improve treatment of the disease.

Structured Findings

500 mg metformin along with their assigned NM504 (GIMM) significantly increased tolerance score to metformin compared to placebo

500 mg metformin along with their assigned NM504 (GIMM) significantly decreased Mean fasting glucose levels compared to placebo

Structured Markup

Intervention	Comparator	Outcome	Label
500 mg metformin along with their assigned NM504 (GIMM)	placebo	tolerance score to metformin	significantly increased
500 mg metformin along with their assigned NM504 (GIMM)	placebo	Mean fasting glucose levels	significantly decreased

PMID26860796  : A comparison study of metformin only therapy and metformin combined with Chinese medicine jianyutangkang therapy in patients with type 2 diabetes: A randomized placebo-controlled double-blind study.

Abstract

The aim of this 26-week, double-blind, controlled clinical trial, was to compare the efficacy of monotherapy (metformin only) with combination therapy (Chinese medicine prescription JianYuTangKang [JYTK] plus metformin) on type 2 diabetes. All patients on metformin were randomized to receive authenticated JYTK (59 patients) or placebo JYTK (53 patients), 4.5g daily, for 26 weeks. Patients also received information regarding diet and exercise. Fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1C) level, and a lipid profile were measured before, during, and after the treatment. The results of the treatment group (JYTK plus metformin) were noninferior to those of the control group (metformin plus placebo) at 8 and 18 weeks. After 26 weeks of treatment, FPG levels decreased to 6.1±1.0mmol/L in the treatment group and 7.0±1.5mmol/L in the control group (p<0.01). HbA1C levels after 26 weeks were also significantly decreased in the treatment group compared with the control group (p<0.01). In addition, lipid profiles were also significantly different between the two groups. Integrated traditional Chinese and Western medicine therapy (JYTK plus metformin) for patients with type 2 diabetes mellitus may not only help improve glycemia and insulin sensitivity, but also help to modify the diabetes related lipid equilibrium. And thereby provides a basis for a novel, effective, and safe approach, to treat type 2 diabetic patients.

Structured Findings

JianYuTangKang [JYTK] plus metformin significantly decreased Fasting plasma glucose (FPG) compared to placebo JYTK

JianYuTangKang [JYTK] plus metformin significantly decreased HbA1C levels compared to placebo JYTK

Structured Markup

Intervention	Comparator	Outcome	Label
JianYuTangKang [JYTK] plus metformin	placebo JYTK	Fasting plasma glucose (FPG)	significantly decreased
JianYuTangKang [JYTK] plus metformin	placebo JYTK	HbA1C levels	significantly decreased

PMID26408873  : Effects of metformin plus gliclazide versus metformin plus glimepiride on cardiovascular risk factors in patients with type 2 diabetes mellitus.

Abstract

High blood glucose level, lipid profile disturbances and plasma homocysteine (Hcy) are important risk factors for cardiovascular diseases in patients with type 2 diabetes. This study was conducted to evaluate and compare effects of glimepiride/metformin combination versus gliclazide/metformin combination on cardiovascular risk factors in type-2 diabetes mellitus (T2DM) patients. One hundred and eighty T2DM patients were randomly allocated for treatment with placebo (control), metformin (500 mg twice daily), glimepiride (3mg once daily), gliclazide (80 mg once daily), metformin plus glimepiride or metformin plus gliclazide for 3 months. We evaluated plasma levels of glucose (PG), glycated hemoglobin (HbA1C), Hcy, vitamin B12, folic acid and lipid profile before treatment and 3 months post treatment. Compared to metformin treated patients, glimepiride plus metformin induced significant reductions in: fasting plasma glucose, postprandial PG level, HbA1C % and Hcy level. Conversely, plasma folic acid and vitamin B12 were significantly increased. The levels of total cholesterol and triglyceride were significantly decreased; low-density lipoprotein was markedly decreased, whereas high-density lipoprotein was significantly increased and hence risk ratio was significantly decreased. Similar results but with lower values were obtained using combination of metformin plus gliclazide on glycemic control only. Combination of glimepiride with metformin was superior to gliclazide plus metformin in alleviating the cardiovascular risk factors in type 2 diabetes mellitus patients.

Structured Findings

glimepiride (3mg once daily), gliclazide (80 mg once daily), metformin plus glimepiride significantly decreased fasting plasma glucose, postprandial PG level, HbA1C % and Hcy level compared to placebo (control)

glimepiride (3mg once daily), gliclazide (80 mg once daily), metformin plus glimepiride significantly decreased the levels of total cholesterol and triglyceride compared to placebo (control)

Structured Markup

Intervention	Comparator	Outcome	Label
glimepiride (3mg once daily), gliclazide (80 mg once daily), metformin plus glimepiride	placebo (control)	fasting plasma glucose, postprandial PG level, HbA1C % and Hcy level	significantly decreased
glimepiride (3mg once daily), gliclazide (80 mg once daily), metformin plus glimepiride	placebo (control)	the levels of total cholesterol and triglyceride	significantly decreased

PMID35217236  : Sitagliptin/metformin improves the fertilization rate and embryo quality in polycystic ovary syndrome patients through increasing the expression of GDF9 and BMP15: A new alternative to metformin (a randomized trial).

Abstract

The aim of this study was to investigate the effects of sitagliptin/metformin (sitaformin), metformin and sitagliptin in PCOS patients. PCOS is a hormonal disorder and therefore the use of treatments that modulate hormone levels Like AMH, testosterone, insulin, leptin and especially FAI and HOMA-IR can reclaim the symptoms of PCOS. PCOS also increases oxidative stress and lipid peroxidation. Therefore, in clinical and research trials, the level of these factors is usually examined to reduce patients' symptoms. Participants were randomly assigned to receive metformin, sitagliptin, sitaformin or placebo Treatment was carried out 2 months before the start of the ovulation cycle and continued until the day of ovum pick up. The serum levels of HOMA-IR and FAI decreased significantly in the treated groups compared to the placebo. The serum and the FF levels of leptin also decreased significantly in the sitaformin group when compared to the metformin and sitagliptin groups. Moreover, the serum and FF levels of AMH and MDA had a significant decrease in the sitaformin and sitagliptin group compared to the placebo. The mRNA expression and protein levels of GDF9 and BMP15 in the cumulus cells increased significantly in the sitaformin compared to metformin and sitagliptin groups. The expression level of GDF9 and BMP15 mRNA were positively correlated with the fertilization rate and grade I embryos. Sitaformin improves levels of GDF9 and BMP15 in PCOS compared to metformin and sitagliptin, which can increase the rate of fertilization and grade I embryos.

Structured Findings

sitagliptin/metformin (sitaformin) significantly decreased HOMA-IR and FAI levels compared to placebo

sitagliptin/metformin (sitaformin) significantly decreased leptin levels compared to placebo

Structured Markup

Intervention	Comparator	Outcome	Label
sitagliptin/metformin (sitaformin)	placebo	HOMA-IR and FAI levels	significantly decreased
sitagliptin/metformin (sitaformin)	placebo	leptin levels	significantly decreased

PMID23984793  : Effects of exenatide and metformin in combination on some adipocytokine levels: a comparison with metformin monotherapy.

Abstract

The aim of this study was to evaluate the effects of exenatide on levels of serum adipocytokines and on β-cell function. The study was conducted between 2008 and 2012. After a run-in period with metformin, 174 patients with type-2 diabetes were randomly distributed to either a group receiving exenatide at 10 μg twice daily, or a group receiving the placebo, for 12 months. We evaluated body mass index (BMI), blood pressure, glycemic control, lipid profile, fasting plasma insulin (FPI), HOMA-IR, HOMA-β, fasting plasma proinsulin (FPPr), proinsulin : fasting plasma insulin ratio (Pr/FPI ratio), C-peptide, glucagon, retinol binding protein-4 (RBP-4), visfatin, omentin-1, and microalbuminuria. We used ELISA methods to assess the various parameters. Patients also underwent a combined euglycemic-hyperinsulinemic and hyperglycemic clamp, with subsequent arginine stimulation. After 12 months, a combination of exenatide and metformin produced a better decrease in body mass, BMI, glycemic control, FPI, FPPr, FPPr/FPI ratio, HOMA-IR, and glucagon level. Treatment with exenatide + metformin was superior to the placebo + metformin in increasing HOMA-β, C-peptide, and β-cell function. Significant negative correlations were found between M value, an index of insulin sensitivity, and measured adipocytokines. In conclusion, the combination of exenatide + metformin plays a role in improving some adipocytokine levels, and is better than metformin alone. The significant negative correlation between M value and measured adipocytokines is another confirmation of the positive effects linked to the improvement in insulin sensitivity.

Structured Findings

exenatide at 10 g twice daily significantly decreased body mass, BMI, glycemic control, FPI, FPPr, FPPr/FPI ratio, HOMA-IR, and glucagon level compared to placebo

Structured Markup

Intervention	Comparator	Outcome	Label
exenatide at 10 g twice daily	placebo	body mass, BMI, glycemic control, FPI, FPPr, FPPr/FPI ratio, HOMA-IR, and glucagon level	significantly decreased

PMID17919894  : The effect of pioglitazone as add-on therapy to metformin or sulphonylurea compared to a fixed-dose combination of metformin and glibenclamide on diabetic dyslipidaemia.

Abstract

BACKGROUND AND AIMS Diabetic dyslipidaemia contributes to the increased risk of cardiovascular disease in patients with Type 2 diabetes. This paper examines the effectiveness of adding pioglitazone to metformin or a sulphonylurea (SU) compared with a fixed-dose combination of metformin and glibenclamide on diabetic dyslipidaemia in patients with Type 2 diabetes. METHODS AND RESULTS Patients (n=250) treated with metformin (< or =3g/day) or an SU as monotherapy at a stable dose for > or =3 months were randomised to receive either pioglitazone (15-30 mg/day) in addition to their metformin or SU, or a fixed-dose combination tablet containing metformin (400mg) and glibenclamide (2.5 mg) [up to 3 tablets daily] for 6 months. Addition of pioglitazone tended to increase plasma high-density lipoprotein-cholesterol (HDL-C) [0.04 mmol/L; P=0.051] at 6 months and significantly reduced plasma triglycerides (-0.25 mmol/L; P=0.013) compared with baseline. Patients treated with metformin/glibenclamide for 6 months had reduced HDL-C (-0.09 mmol/L; P<0.01) and no change in plasma triglyceride levels (0.03 mmol/L; P=0.733). Both treatment regimes resulted in a similar level of glycaemic control. CONCLUSION The beneficial effects of pioglitazone on diabetic dyslipidaemia may help combat the increased cardiovascular morbidity and mortality observed in patients with Type 2 diabetes while providing stable glycaemic control.

Structured Findings

Pioglitazone (15-30 mg/day) in addition to metformin or sulphonylurea (SU) significantly increased Plasma high-density lipoprotein-cholesterol (HDL-C) compared to baseline

Pioglitazone (15-30 mg/day) in addition to metformin or sulphonylurea (SU) significantly decreased Plasma triglycerides compared to baseline

Structured Markup

Intervention	Comparator	Outcome	Label
Pioglitazone (15-30 mg/day) in addition to metformin or sulphonylurea (SU)	baseline	Plasma high-density lipoprotein-cholesterol (HDL-C)	significantly increased
Pioglitazone (15-30 mg/day) in addition to metformin or sulphonylurea (SU)	baseline	Plasma triglycerides	significantly decreased