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PMID21989078  : The pharmacogenetics of metformin and its impact on plasma metformin steady-state levels and glycosylated hemoglobin A1c.

Abstract

OBJECTIVE The aim of this study was to evaluate the effect of genetic variations in OCT1, OCT2, MATE1, MATE 2, and PMAT on the trough steady-state plasma concentration of metformin and hemoglobin A1c (Hb1Ac). METHOD The South Danish Diabetes Study was a 2 x 2 x 2 factorial, prospective, randomized, double-blind, placebo-controlled, multicentre study. One hundred and fifty-nine patients received 1 g of metformin, twice daily continuously, and 415 repeated plasma metformin measurements were obtained after 3, 6, and 9 months of treatment. RESULTS The mean trough steady-state metformin plasma concentration was estimated to be 576 ng/ml (range, 54–4133 ng/ml, p = 0.55) and correlated to the number of reduced function alleles in OCT1 (none, one or two: 642, 542, 397 ng/ml; P = 0.001). The absolute decrease in Hb1Ac both initially and long term was also correlated to the number of reduced function alleles in OCT1 resulting in diminished pharmacodynamic effect of metformin after 6 and 24 months. CONCLUSION In a large cohort of type 2 diabetics, we either confirm or show for the first time: (a) an enormous (80-fold) variability in trough steady-state metformin plasma concentration, (b) OCT1 activity affects metformin steady-state pharmacokinetics, and (c) OCT1 genotype has a bearing on HbA1c during metformin treatment.

Structured Findings

1 g of metformin, twice daily continuously significantly increased The mean trough steady-state metformin plasma concentration compared to placebo

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Intervention	Comparator	Outcome	Label
1 g of metformin, twice daily continuously	placebo	The mean trough steady-state metformin plasma concentration	significantly increased

PMID16478764  : Efficacy of combined metformin-letrozole in comparison with metformin-clomiphene citrate in clomiphene-resistant infertile women with polycystic ovarian disease.

Abstract

BACKGROUND Adding metformin to clomiphene citrate in clomiphene-resistant polycystic ovary syndrome (PCOS) patients increases ovulatory response. However, because of anti-estrogenic effects of clomiphene it may be associated with lower pregnancy rate, offsetting the ovulation rate benefit. Letrozole is an aromatase inhibitor which induces ovulation without anti-estrogenic effects. METHODS Infertile women with PCOS were randomly divided into metformin-letrozole (29 patients) and metformin-clomiphene groups (30 patients). After an initial 6-8 weeks of metformin, they received either letrozole (2.5 mg) or clomiphene (100 mg) from day 3-7 of their menstrual cycle. Estradiol (E2) levels, number of follicles, pregnancy rates and endometrial thickness were measured on the day of HCG administration. RESULTS Mean total E2 and E2 per mature follicle were significantly higher in clomiphene group without a difference in mean number of mature follicles >18 mm and ovulation rate. Endometrial thickness was significantly higher in letrozole group. The pregnancy rate in letrozole group (10 patients, 34.50%) as compared with clomiphene group (5 patients, 16.67%) did not show significant difference, whereas full-term pregnancies were higher in letrozole group [10 patients (34.50%) versus 3 patients (10%)]. CONCLUSION In clomiphene-resistant PCOS patients, the combination of letrozole and metformin leads to higher full-term pregnancies.

Structured Findings

letrozole (2.5 mg) significantly decreased Estradiol (E2) levels compared to clomiphene (100 mg)

letrozole (2.5 mg) significantly increased Endometrial thickness compared to clomiphene (100 mg)

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Intervention	Comparator	Outcome	Label
letrozole (2.5 mg)	clomiphene (100 mg)	Estradiol (E2) levels	significantly decreased
letrozole (2.5 mg)	clomiphene (100 mg)	Endometrial thickness	significantly increased

PMID22682949  : Effects of a combination of sitagliptin plus metformin vs metformin monotherapy on glycemic control, β-cell function and insulin resistance in type 2 diabetic patients.

Abstract

AIMS To evaluate the impact on glycemic control, insulin resistance, and insulin secretion of sitagliptin+metformin compared to metformin in type 2 diabetic patients. METHODS Patients were instructed to take metformin for 8 ± 2 months, then they were randomly assigned to sitaglipin 100 mg or placebo for 12 months. We evaluated at 3, 6, 9, and 12 months: body mass index (BMI), glycemic control, fasting plasma insulin (FPI), HOMA-IR, HOMA-β, fasting plasma proinsulin (FPPr), proinsulin/fasting plasma insulin ratio (Pr/FPI ratio), C-peptide, glucagon, adiponectin (ADN), and high sensitivity-C reactive protein (Hs-CRP). Before, and after 12 months since the addition of sitagliptin, patients underwent a combined euglycemic hyperinsulinemic and hyperglycemic clamp, with subsequent arginine stimulation. RESULTS Both treatments similarly decreased body weight, and BMI; on the other hand, they both improved glycemic control, glucagon and HOMA-IR, but sitagliptin+metformin were more effective in reducing these parameters. Sitagliptin+metformin, but not placebo+metformin, decreased FPPr, FPPR/FPI ratio, and increased C-peptide values, even if no differences between the groups were recorded. Sitaglitin+metformin gave also a greater increase of HOMA-β, M value, C-peptide response to arginine and disposition index compared to placebo+metformin group. CONCLUSIONS Other than improving glycemic control, sitagliptin+metformin also improved β-cell function better than metformin alone.

Structured Findings

Sitagliptin + Metformin significantly decreased FPPr, FPPR/FPI ratio, and increased C-peptide values compared to Placebo + Metformin

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Intervention	Comparator	Outcome	Label
Sitagliptin + Metformin	Placebo + Metformin	FPPr, FPPR/FPI ratio, and increased C-peptide values	significantly decreased

PMID21704212  : Effects of metformin in adolescents with polycystic ovary syndrome undertaking lifestyle therapy: a pilot randomized double-blind study.

Abstract

Our small study does not support the addition of metformin to the lifestyle of adolescents. Although there are favorable trends toward hyperandrogenism with metformin, these must be balanced against the increased rate of gastrointestinal side effects. However, other treatments were associated with an improved quality of life.

Structured Findings

Metformin and Control had no significant difference on Quality of life

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Intervention	Comparator	Outcome	Label
Metformin	Control	Quality of life	no significant difference

PMID29141460  : Safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin and low-dose metformin.

Abstract

BACKGROUND This study investigated the safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin (100 mg/day) and low-dose metformin (500 or 750 mg/day). RESEARCH DESIGN AND METHODS Fifty patients were randomly allocated to the control group (maintaining the initial low-dose of metformin) and the dose increase group (up-titrating of metformin to 1,500-2,250 mg/day) for 24 weeks. The primary outcome was change in HbA1c from baseline to 24 weeks. RESULTS Among the 25 patients allocated to the dose increase group, four patients were not able to complete the study protocol because of gastrointestinal symptoms. HbA1c in the dose increase group was significantly but modestly lower than in the control group (change in HbA1c: 0.22 ± 0.57 vs. -0.15 ± 0.58%, group comparison, P < 0.05). The dose increase group did not gain weight during the study period, and no hypoglycemic events were reported in both groups. The rate of gastrointestinal symptoms in the dose increase group was profoundly higher than in the control group (32 vs. 0%, P < 0.01). CONCLUSIONS In Japanese patients with type 2 diabetes treated with vildagliptin and low-dose metformin, metformin up-titration significantly but modestly improved glycemic control without hypoglycemia and weight gain.

Structured Findings

Metformin up-titration significantly decreased HbA1c compared to Control

Metformin up-titration significantly increased The rate of gastrointestinal symptoms compared to Control

Structured Markup

Intervention	Comparator	Outcome	Label
Metformin up-titration	Control	HbA1c	significantly decreased
Metformin up-titration	Control	The rate of gastrointestinal symptoms	significantly increased

PMID31149153  : COMPARISON OF FINASTERIDE, METFORMIN, AND FINASTERIDE PLUS METFORMIN IN PCOS.

Abstract

The effects of finasteride on insulin resistance and of metformin on hyperandrogenism in patients with polycystic ovary syndrome (PCOS) are not clear. This study therefore compared the effects of finasteride, metformin, and finasteride plus metformin treatments on hormone levels, insulin resistance, and hirsutism score in women with PCOS. Fifty-two patients with PCOS were randomly assigned to receive finasteride 5 mg/day, metformin 1700 mg/day or finasteride plus metformin for 12 months. Body mass index (BMI), Ferriman Gallway score (FGS), serum concentrations of estradiol, sex hormone-binding globulin, free testosterone, dehydroepiandrosterone sulfate (DHEAS), androstenedione, and homeostasis model assessment of insulin resistance (HOMA-IR) index and areas under the curve (AUC) for insulin and glucose were evaluated before and after 12 months of treatment. Reductions in FGS, free testosterone, DHEAS, androstenedione, HOMA-IR, AUC-insulin, and AUC-glucose were significant within each group, whereas BMI and estradiol were not. Comparisons of changes in parameters in the 3 groups did not clearly show the superiority of any treatment modality. The treatment with finasteride alone significantly reduced both androgen levels and parameters of insulin resistance. In addition, metformin alone was effective, and not inferior to finasteride, in the treatment of hyperandrogenism.

Structured Findings

Finasteride 5 mg/day, metformin 1700 mg/day or finasteride plus metformin for 12 months significantly decreased Ferriman Gallway score (FGS), free testosterone, DHEAS, androstenedione, HOMA-IR, AUC-insulin, and AUC-glucose compared to Finasteride 5 mg/day, metformin 1700 mg/day or finasteride plus metformin for 12 months

Structured Markup

Intervention	Comparator	Outcome	Label
Finasteride 5 mg/day, metformin 1700 mg/day or finasteride plus metformin for 12 months	Finasteride 5 mg/day, metformin 1700 mg/day or finasteride plus metformin for 12 months	Ferriman Gallway score (FGS), free testosterone, DHEAS, androstenedione, HOMA-IR, AUC-insulin, and AUC-glucose	significantly decreased

PMID23020608  : Metformin vs. insulin in gestational diabetes. A randomized study characterizing metformin patients needing additional insulin.

Abstract

AIMS We compared metformin with insulin as treatment of gestational diabetes mellitus (GDM). Furthermore, we aimed to characterize metformin-treated patients needing additional insulin to achieve prespecified glucose targets. METHODS We conducted a single centre randomized controlled study with non-inferiority design comparing metformin and insulin in the treatment of 217 GDM patients having birth weight as primary outcome variable. RESULTS There were no significant differences in mean birth weight expressed in grams [+15 (90% confidence interval (CI): -121 to 89)] or SD units [+0.04 (90% CI: -0.27 to 0.18)] between the metformin and insulin groups. There were no significant differences in neonatal or maternal data between the groups. Only 23 (20.9%) of the 110 patients in the metformin group needed additional insulin. Compared with the patients on metformin only, those needing additional insulin were older (p = 0.04), their oral glucose tolerance test had been performed earlier and diabetes therapy started earlier in gestation (p = 0.01 and p = 0.004, respectively). The risk for additional insulin was 4.6-fold in women with baseline serum fructosamine concentration above median compared with those below median. CONCLUSIONS Metformin is an effective alternative to insulin in the treatment of GDM patients. Serum fructosamine may help in predicting the adequacy of metformin treatment alone.

Structured Findings

metformin and insulin had no significant difference on mean birth weight expressed in grams

metformin and insulin had no significant difference on mean birth weight expressed in units

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Intervention	Comparator	Outcome	Label
metformin	insulin	mean birth weight expressed in grams	no significant difference
metformin	insulin	mean birth weight expressed in units	no significant difference

PMID25841300  : Saxagliptin is similar in glycaemic variability more effective in metabolic control than acarbose in aged type 2 diabetes inadequately controlled with metformin.

Abstract

This study compared the effects on glycaemic variability and glucose control between saxagliptin and acarbose as add-on therapies for aged T2DM inadequately controlled with metformin alone. The results showed that compared with acarbose-metformin, saxagliptin-metformin was more effective in glucose control with similar glycaemic variability.

Structured Findings

saxagliptin significantly decreased glycaemic variability compared to acarbose-metformin

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Intervention	Comparator	Outcome	Label
saxagliptin	acarbose-metformin	glycaemic variability	significantly decreased

PMID16169430  : Metformin treatment in patients with polycystic ovary syndrome undergoing in vitro fertilization: a prospective randomized trial.

Abstract

In the present study, we investigated the impact of metformin therapy on in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes in patients with polycystic ovary syndrome (PCOS). Metformin does not lead to any improvement in IVF/ICSI outcomes among patients with PCOS.

Structured Findings

Metformin and Control had no significant difference on IVF/ICSI outcomes

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Intervention	Comparator	Outcome	Label
Metformin	Control	IVF/ICSI outcomes	no significant difference

PMID16500361  : Beneficial effect of metformin on pregnancy outcome in women with polycystic ovary syndrome is not associated with major changes in C-reactive protein levels or indices of coagulation.

Abstract

In women with polycystic ovary syndrome, C-reactive protein levels and D-dimer, antithrombin III, activated protein C resistance, and activated partial thromboplastin time were unaffected by metformin treatment throughout pregnancy. Protein C levels increased slightly in the metformin group compared with the placebo group.

Structured Findings

Metformin significantly increased Protein C levels compared to Placebo

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Intervention	Comparator	Outcome	Label
Metformin	Placebo	Protein C levels	significantly increased