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PMID19155004  : Metabolic and endocrine effects of metformin and metformin plus cyclic medroxyprogesterone acetate in women with polycystic ovary syndrome.

Abstract

OBJECTIVE To evaluate the metabolic and endocrine effects of treatment with cyclic medroxyprogesterone acetate (MPA) plus metformin compared with metformin alone in women with PCOS. METHODS In this prospective randomized study of women with PCOS, 20 women received 850 mg of metformin twice a day, and 20 women received 850 mg of metformin plus 5 mg of MPA twice a day. Body mass index, hormonal and lipid blood profiles, homocysteine blood level, and insulin sensitivities assessed by homeostasis model assessment (HOMA) were recorded at baseline and at 3 months. RESULTS Total cholesterol levels decreased in the metformin plus MPA group (P=0.002) but did not change significantly in the metformin group (P=0.159). While homocysteine levels remained unchanged in the metformin plus MPA group, they increased significantly in the metformin group (P=0.002). CONCLUSION There were no adverse effects of short-term cyclic MPA plus metformin treatment on metabolic parameters or insulin resistance in patients with PCOS over a 3-month treatment period.

Structured Findings

cyclic medroxyprogesterone acetate (MPA) plus metformin significantly decreased Total cholesterol levels compared to metformin alone

cyclic medroxyprogesterone acetate (MPA) plus metformin significantly increased Homocysteine levels compared to metformin alone

Structured Markup

Intervention	Comparator	Outcome	Label
cyclic medroxyprogesterone acetate (MPA) plus metformin	metformin alone	Total cholesterol levels	significantly decreased
cyclic medroxyprogesterone acetate (MPA) plus metformin	metformin alone	Homocysteine levels	significantly increased

PMID14967392  : Dexamethasone reduces androgen levels in metformin-treated patients with polycystic ovary syndrome.

Abstract

Women with polycystic ovary syndrome treated with metformin and lifestyle advice were studied. Additional treatment with dexamethasone, but not with bromocriptine, further reduced circulating androgen levels.

Structured Findings

Dexamethasone significantly decreased Androgen levels compared to Bromocriptine

Structured Markup

Intervention	Comparator	Outcome	Label
Dexamethasone	Bromocriptine	Androgen levels	significantly decreased

PMID27406394  : Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION).

Abstract

AIMS To compare the efficacy and safety of combination of vildagliptin and metformin therapy with metformin uptitration in Chinese patients with type 2 diabetes (T2DM) inadequately controlled with low-dose metformin. METHODS In this 24-week prospective, randomized, multicentre, open-label study, patients with T2DM inadequately controlled with metformin ≤1000 mg daily were divided 1 : 1 : 1 : 1 into four prespecified subgroups based on age and body mass index (BMI). Patients in each subgroup were randomized 5 : 1 to receive either vildagliptin (50 mg twice daily) plus metformin [500 mg twice daily; vildagliptin and low-dose metformin (VLDM) group] or metformin uptitration [1000 mg twice daily; high-dose metformin (HDM) group]. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline at week 24. The key secondary endpoints included percentage of patients achieving target HbA1c without adverse gastrointestinal (GI) events and mean change in fasting plasma glucose (FPG) from baseline to week 24. RESULTS A total of 3084 patients were randomized. HbA1c reduction of 0.54% at week 24 in the VLDM group was non-inferior and statistically superior compared with 0.40% in the HDM group (P < 0.0001). VLDM's non-inferiority to HDM was confirmed in the four subgroups and its superiority was shown for all subgroups (p < 0.05) except for the subgroup of patients aged <60 years with a BMI of ≥24 kg/m(2) . Compared with HDM, VLDM significantly increased the percentage of patients achieving HbA1c ≤6.5% and HbA1c ≤6.5% without GI events. FPG levels in the VLDM group were lower at week 24 numerically than in the HDM group. The two treatment arms had similar safety profiles. CONCLUSIONS VLDM was non-inferior and statistically superior to HDM in glycaemic control in Chinese patients with T2DM inadequately controlled with low-dose metformin.

Structured Findings

vildagliptin (50 mg twice daily) plus metformin [500 mg twice daily; vildagliptin and low-dose metformin (VLDM) group] and metformin uptitration [1000 mg twice daily; high-dose metformin (HDM) group] had no significant difference on HbA1c reduction

Structured Markup

Intervention	Comparator	Outcome	Label
vildagliptin (50 mg twice daily) plus metformin [500 mg twice daily; vildagliptin and low-dose metformin (VLDM) group]	metformin uptitration [1000 mg twice daily; high-dose metformin (HDM) group]	HbA1c reduction	no significant difference

PMID23105685  : A comparative study on the effects of diet and exercise, metformin and metformin+pioglitazone treatment on NIDDM patients.

Abstract

A comparative study on two groups of newly diagnosed nonobese and obese NIDDM patients who were 15 in each group and treated by diet cum exercise and metfromin monotherapy respectively and a third group of 15 obese NIDDM patients whose hyperglycemia was not first controlled by a combination therapy of metformin and sulfonylurea and therefore changed over to a different combination therapy of metformin and ploglitazone, was carried out before and after a period of three months treatment. The mild hyperglycemia in the 1(st) group and the moderate or severe hyperglycemia with accompanied disorders of serum enzymes such as AST, ALT, GGT and the level of HBA(10) observed with 2(nd) and 3(rd) groups of obese NIDDM patients were significantly ameliorated by the respective mode of treatments. Here the efficacies of the three types of treatment are substantiated and further it specifically depicts the success with the choice of combination therapy with metformin and pioglitazone in the third group of obese diabetics.

Structured Findings

Metformin and ploglitazone significantly decreased HBA(10) compared to Diet cum exercise and metformin monotherapy

Structured Markup

Intervention	Comparator	Outcome	Label
Metformin and ploglitazone	Diet cum exercise and metformin monotherapy	HBA(10)	significantly decreased

PMID26893954  : Solid Dose Form of Metformin with Ethyl Eicosapentaenoic Acid Does Not Improve Metformin Plasma Availability.

Abstract

BACKGROUND The purpose of the study was to investigate effects of ethyl eicosapentaenoic acid on pharmacokinetics of metformin. Pharmacokinetic profiles of metformin and ethyl eicosapentaenoic acid when delivered separately or together in solid dose form were investigated and compared to determine whether the solid dose resulted in an altered metforminpharmacokinetics when given with or without food. METHODS A single-center, open-label, repeated dose study investigated the pharmacokinetic (PK) profile of metformin when administered in solid dose form with ethyl eicosapentaenoic acid compared to co-administration with icosapent ethyl, an ester of eicosapentaenoic acid and ethyl alcohol used to treat severe hypertriglyceridemia with metformin hydrochloride. Non-compartmental PK methods were used to compare area under the plasma concentration curve (AUC) and maximum plasma concentration (C max ) between patients randomized to either the ester or separate medications group under both fasting and fed conditions. RESULTS Using these two PK parameters, results showed that metformin availability was higher under fasting conditions when delivered separately from icosapent ethyl. There were no group differences in the fed condition. CONCLUSIONS The solid dose form of metformin and ethyl eicosapentaenoic acid did not improve the pharmacokinetics of metformin in terms of plasma availability, suggesting that little is to be gained over the separate administration of ethyl eicosapentaenoic acid and metformin hydrochloride.

Structured Findings

Ethyl eicosapentaenoic acid and Ethyl alcohol had no significant difference on Maximum plasma concentration

Structured Markup

Intervention	Comparator	Outcome	Label
Ethyl eicosapentaenoic acid	Ethyl alcohol	Maximum plasma concentration	no significant difference

PMID29544572  : Effect of Metformin Alone Compared with Metformin Plus Simvastatin on Polycystic Ovarian Syndrome in Pakistani Women.

Abstract

OBJECTIVE To determine the efficacy of metformin alone versus metformin plus simvastatin for treatment of polycystic ovariansyndrome (PCOS). STUDY DESIGN Randomized controlled trial. PLACE AND DURATION OF STUDY Maternal and Child Health Centre, Unit II, Pakistan Institute of Medical Sciences (PIMS), from November 2014 to April 2015. METHODOLOGY One hundred and eight patients (108) were randomly divided into metformin group (n=54) and metformin plus simvastatin group (n=54), detailed clinical history, including menstrual details, was taken with thorough examination performed. Baseline ultrasound was performed to evaluate ovarian size and these were considered enlarged with volume >10cc or with >12 follicles in any one ovary. Blood samples were taken at baseline and after three months of therapy to determine the LH/FSH ratio and lipid profile. Efficacy was defined as >15% decrease in the baseline values. RESULTS The mean age of patients was 28.82 ±7.18 years. Mean BMI of the patients was 22.41 ±1.55 Kg/m2. Efficacy was achieved in 66.7% patients with metformin alone, while in 92.6% with combination medication (p=0.001). CONCLUSION The combination of metformin plus simvastatin is more efficacious as compared to metformin alone for management of females with PCOS.

Structured Findings

Metformin plus simvastatin significantly increased Efficacy compared to Metformin alone

Structured Markup

Intervention	Comparator	Outcome	Label
Metformin plus simvastatin	Metformin alone	Efficacy	significantly increased

PMID24528246  : Both glimepiride and high-dose metformin are important for sustained glucose lowering in Japanese type 2 diabetes patients on glimepiride-sitagliptin-metformin therapy: subanalysis of a single-center, open-label, randomized study.

Abstract

BACKGROUND In a previous single-center, open-label randomized 3-month study of triple oral antidiabetes drug (OAD) therapy, we investigated factors affecting the glycemic control afforded by sitagliptin, high-dose metformin, and low-dose glimepiride. Patients were prospectively assigned to either Group 1 (50% reduction in metformin) or Group 2 (discontinuation of glimepiride) and compared. The results showed that the glycated hemoglobin (HbA1c) levels of patients in Group 2 deteriorated more than those in Group 1, whereas HbA1c levels were maintained in some patients in both groups. MATERIALS AND METHODS To determine the factors associated with maintenance of HbA1c under this triple OAD regimen, data from the prospective study were further analyzed. RESULTS In both Groups 1 and 2, the baseline HbA1c level was higher in patients with HbA1c ≥7.0% after 3 months of treatment than those with an HbA1c level of <7.0%. A generalized linear model revealed that high-dose metformin was associated with a deterioration of HbA1c levels in Group 2. CONCLUSIONS Together, the findings indicate that glimepiride and high-dose metformin are important for sustained glycemic control in triple OAD therapy with sitagliptin, metformin, and sulfonylurea.

Structured Findings

Group 1 (50% reduction in metformin) significantly increased HbA1c level compared to Group 2 (discontinuation of glimepiride)

Structured Markup

Intervention	Comparator	Outcome	Label
Group 1 (50% reduction in metformin)	Group 2 (discontinuation of glimepiride)	HbA1c level	significantly increased

PMID19463994  : An assessment of lifestyle modification versus medical treatment with clomiphene citrate, metformin, and clomiphene citrate-metformin in patients with polycystic ovary syndrome.

Abstract

OBJECTIVE To compare the effect of clomiphene citrate, metformin, and lifestyle modification on treatment of patients with polycystic ovary syndrome (PCOS). DESIGN Prospective randomized double-blind study. SETTING University-based infertility clinic and research center. PATIENT(S) Three hundred forty-three overweight infertile women with PCOS. INTERVENTION(S) The participating women were assigned to four groups: clomiphene (n = 90), metformin (n = 90), clomiphene + metformin (n = 88), and lifestyle modification (n = 75). The patients in each group received standardized dietary and exercise advice from a dietitian. MAIN OUTCOME MEASURE(S) The primary outcome variables were change in menstrual cycle, waist circumference measurements, endocrine parameters, and lipid profile. The main secondary outcome variable was clinical pregnancy rate. RESULT(S) The clinical pregnancy rate was 12.2% in clomiphene group, 14.4% in metformin group, 14.8% in clomiphene + metformin group, and 20% in lifestyle modification group. Lifestyle modification group achieved a significant reduction in waist circumference, total androgen, and lipid profile. CONCLUSION(S) Lifestyle modification improves the lipid profile in PCOS patients. Therefore, lifestyle modification may be used as the first line of ovulation induction in PCOS patients.

Structured Findings

Clomiphene citrate significantly decreased The clinical pregnancy rate compared to Metformin

Structured Markup

Intervention	Comparator	Outcome	Label
Clomiphene citrate	Metformin	The clinical pregnancy rate	significantly decreased

PMID27407018  : Effects of SLC22A1 Polymorphisms on Metformin-Induced Reductions in Adiposity and Metformin Pharmacokinetics in Obese Children With Insulin Resistance.

Abstract

Steady-state population pharmacokinetics of a noncommercial immediate-release metformin (hydrochloride) drug product were characterized in 28 severely obese children with insulin resistance. The concentration-time profiles with double peaks were well described by a 1-compartment model with 2 absorption sites. Mean population apparent clearance (CL/F) was 68.1 L/h, and mean apparent volume of distribution (V/F) was 28.8 L. Body weight was a covariate of CL/F and V/F. Estimated glomerular filtration rate was a significant covariate of CL/F (P < .001). SLC22A1 genotype did not significantly affect metformin pharmacokinetics. The response to 6 months of metformin treatment (HbA 1c , homeostasis model assessment for insulin resistance, fasting insulin, and glucose changes) did not differ between SLC22A1 wild-type subjects and carriers of presumably low-activity SLC22A1 alleles. However, SLC22A1 variant carriers had smaller reductions in percentage of total trunk fat after metformin therapy, although the percentage reduction in trunk fat was small. The median % change in trunk fat was -2.20% (-9.00% to 0.900%) and -1.20% (-2.40% to 7.30%) for the SLC22A1 wild-type subjects and variant carriers, respectively. Future study is needed to evaluate the effects of SLC22A1 polymorphisms on metformin-mediated weight reduction in obese children.

Structured Findings

SLC22A1 genotype and control had no significant difference on Glomerular filtration rate

SLC22A1 genotype and control had no significant difference on The response to 6 months of metformin treatment

Structured Markup

Intervention	Comparator	Outcome	Label
SLC22A1 genotype	control	Glomerular filtration rate	no significant difference
SLC22A1 genotype	control	The response to 6 months of metformin treatment	no significant difference

PMID30252913  : Improved glycemic control with minimal systemic metformin exposure: Effects of Metformin Delayed-Release (Metformin DR) targeting the lower bowel over 16 weeks in a randomized trial in subjects with type 2 diabetes.

Abstract

OBJECTIVE Metformin use is restricted in patients with renal impairment due to potential excess systemic accumulation. This study evaluated the glycemic effects and safety of metformin delayed-release (Metformin DR), which targets metformin delivery to the ileum to leverage its gut-based mechanisms of action while minimizing systemic exposure. RESEARCH DESIGNS AND METHODS Participants (T2DM [HbA1c 7-10.5%], eGFR ≥60 mL/min/1.73m2, not taking metformin for ≥2 months) were randomized to QD placebo (PBO); QD Metformin DR 600, 900, 1200, or 1500 mg; or to single-blind BID Metformin immediate-release (IR) 1000 mg. The primary endpoint was change in HbA1c for Metformin DR vs. PBO at 16 weeks in the modified intent-to-treat (mITT) population (≥ 1 post-baseline HbA1c while on study drug), using a mixed-effects repeated measures model. RESULTS 571 subjects were randomized (56 years, 53% male, 80% white; BMI 32.2±5.5 kg/m2; HbA1c 8.6±0.9%; 51% metformin naive); 542 were in the mITT population. Metformin DR 1200 and 1500 mg significantly reduced HbA1c (-0.49±0.13% and -0.62±0.12%, respectively, vs. PBO -0.06±0.13%; p<0.05) and FPG (Caverage Weeks 4-16: -22.3±4.2 mg/dL and -25.1±4.1 mg/dL, respectively vs. -2.5±4.2 mg/dL p<0.05). Metformin IR elicited greater HbA1c improvement (-1.10±0.13%; p<0.01 vs. Placebo and all doses of Metformin DR) but with ~3-fold greater plasma metformin exposure. Normalizing efficacy to systemic exposure, glycemic improvements with Metformin DR were 1.5-fold (HbA1c) and 2.1-fold (FPG) greater than Metformin IR. Adverse events were primarily gastrointestinal but these were less frequent with Metformin DR (<16% incidence) vs. Metformin IR (28%), particularly nausea (1-3% vs 10%). CONCLUSION Metformin DR exhibited greater efficacy per unit plasma exposure than Metformin IR. Future studies will evaluate the effects of Metformin DR in patients with type 2 diabetes and advanced renal disease. TRIAL REGISTRATION Clinicaltrials.gov NCT02526524.

Structured Findings

Metformin delayed-release (Metformin DR) 1200 and 1500 mg significantly decreased HbA1c improvement compared to Placebo

Metformin delayed-release (Metformin DR) 1200 and 1500 mg significantly decreased FPG improvement compared to Placebo

Structured Markup

Intervention	Comparator	Outcome	Label
Metformin delayed-release (Metformin DR) 1200 and 1500 mg	Placebo	HbA1c improvement	significantly decreased
Metformin delayed-release (Metformin DR) 1200 and 1500 mg	Placebo	FPG improvement	significantly decreased