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We began analyzing https://link.springer.com/article/10.1007/s00125-013-3039-1, but it redirected us to https://link.springer.com/article/10.1007/s00125-013-3039-1. The analysis below is for the second page.

Title[redir]:
Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial | Diabetologia
Description:
The aim of this work was to evaluate the efficacy and safety of canagliflozin vs placebo and sitagliptin in patients with type 2 diabetes who were being treated with background metformin. This randomised, double-blind, four-arm, parallel-group, Phase 3 study was conducted at 169 centres in 22 countries between April 2010 and August 2012. Participants (N = 1,284) with type 2 diabetes aged ≥18 and ≤80 years who had inadequate glycaemic control (HbA1c ≥7.0% [53 mmol/mol] and ≤10.5% [91 mmol/mol]) on metformin therapy received canagliflozin 100 mg or 300 mg, sitagliptin 100 mg, or placebo (n = 368, 367, 366, 183, respectively) for a 26 week, placebo- and active-controlled period followed by a 26 week, active-controlled period (placebo group switched to sitagliptin [placebo/sitagliptin]) and were included in the modified intent-to-treat analysis set. Randomisation was performed using a computer-generated schedule; participants, study centres and the sponsor were blinded to group assignment. The primary endpoint was change from baseline in HbA1c at week 26; secondary endpoints included changes in HbA1c (week 52) and fasting plasma glucose (FPG), body weight, and systolic blood pressure (BP; weeks 26 and 52). Adverse events (AEs) were recorded throughout the study. At week 26, canagliflozin 100 mg and 300 mg reduced HbA1c vs placebo (−0.79%, –0.94%, –0.17%, respectively; p < 0.001). At week 52, canagliflozin 100 mg and 300 mg demonstrated non-inferiority, and canagliflozin 300 mg demonstrated statistical superiority, to sitagliptin in lowering HbA1c (−0.73%, –0.88%,–0.73%, respectively); differences (95% CI) vs sitagliptin were 0% (−0.12, 0.12) and −0.15% (−0.27, –0.03), respectively. Canagliflozin 100 mg and 300 mg reduced body weight vs placebo (week 26: –3.7%, –4.2%, –1.2%, respectively; p < 0.001) and sitagliptin (week 52: –3.8%, –4.2%, –1.3%, respectively; p < 0.001). Both canagliflozin doses reduced FPG and systolic BP vs placebo (week 26) and sitagliptin (week 52) (p < 0.001). Overall AE and AE-related discontinuation rates were generally similar across groups, but higher with canagliflozin 100 mg. Genital mycotic infection and osmotic diuresis-related AE rates were higher with canagliflozin; few led to discontinuations. Hypoglycaemia incidence was higher with canagliflozin. Canagliflozin improved glycaemia and reduced body weight vs placebo (week 26) and sitagliptin (week 52) and was generally well tolerated in patients with type 2 diabetes on metformin. ClinicalTrials.gov NCT01106677 This study was supported by Janssen Research & Development, LLC.

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Keywords {🔍}

canagliflozin, week, sitagliptin, diabetes, placebo, study, type, metformin, period, participants, hbac, baseline, weeks, table, patients, incidence, article, treatment, change, safety, mmolmol, placebositagliptin, statistical, efficacy, glucose, weight, groups, observed, control, body, aes, higher, google, scholar, glycaemic, therapy, fpg, compared, randomised, doses, prespecified, effect, reduced, similar, increases, analysis, research, trial, doubleblind, received,

Topics {✒️}

mixed-meal tolerance test bristol-myers squibb/astrazeneca article download pdf distinct risk/benefit profiles ldl-cholesterol/hdl-cholesterol ratio active-controlled noninferiority trial urinary tract infection osmotic diuresis-related aes computer-generated randomisation schedule privacy choices/manage cookies ae-related discontinuation rates electronic supplementary material article lavalle-gonzález 2 week single-blind computer-generated schedule observation carried forward full-time employees received research support reduced body weight double-blind treatment period monitored blood glucose genital mycotic infections american diabetes association reduced intravascular volume full access metformin extended release european economic area blood glucose control active-controlled studies [8 placebo-controlled 102-week trial blood urea nitrogen studies comparing canagliflozin genital mycotic infection net caloric loss inadequate glycaemic control received rescue therapy additional sulfonylurea treatment stable metformin therapy fasting plasma glucose including myocardial infarction vital sign measurements light-grey triangles adequate archived samples broad age range cpmp/ewp/1080/00 rev 48th annual meeting 73rd scientific sessions adequate glycemic control inadequate glycemic control mild osmotic diuresis

Schema {🗺️}

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         description:The aim of this work was to evaluate the efficacy and safety of canagliflozin vs placebo and sitagliptin in patients with type 2 diabetes who were being treated with background metformin. This randomised, double-blind, four-arm, parallel-group, Phase 3 study was conducted at 169 centres in 22 countries between April 2010 and August 2012. Participants (N = 1,284) with type 2 diabetes aged ≥18 and ≤80 years who had inadequate glycaemic control (HbA1c ≥7.0% [53 mmol/mol] and ≤10.5% [91 mmol/mol]) on metformin therapy received canagliflozin 100 mg or 300 mg, sitagliptin 100 mg, or placebo (n = 368, 367, 366, 183, respectively) for a 26 week, placebo- and active-controlled period followed by a 26 week, active-controlled period (placebo group switched to sitagliptin [placebo/sitagliptin]) and were included in the modified intent-to-treat analysis set. Randomisation was performed using a computer-generated schedule; participants, study centres and the sponsor were blinded to group assignment. The primary endpoint was change from baseline in HbA1c at week 26; secondary endpoints included changes in HbA1c (week 52) and fasting plasma glucose (FPG), body weight, and systolic blood pressure (BP; weeks 26 and 52). Adverse events (AEs) were recorded throughout the study. At week 26, canagliflozin 100 mg and 300 mg reduced HbA1c vs placebo (−0.79%, –0.94%, –0.17%, respectively; p < 0.001). At week 52, canagliflozin 100 mg and 300 mg demonstrated non-inferiority, and canagliflozin 300 mg demonstrated statistical superiority, to sitagliptin in lowering HbA1c (−0.73%, –0.88%,–0.73%, respectively); differences (95% CI) vs sitagliptin were 0% (−0.12, 0.12) and −0.15% (−0.27, –0.03), respectively. Canagliflozin 100 mg and 300 mg reduced body weight vs placebo (week 26: –3.7%, –4.2%, –1.2%, respectively; p < 0.001) and sitagliptin (week 52: –3.8%, –4.2%, –1.3%, respectively; p < 0.001). Both canagliflozin doses reduced FPG and systolic BP vs placebo (week 26) and sitagliptin (week 52) (p < 0.001). Overall AE and AE-related discontinuation rates were generally similar across groups, but higher with canagliflozin 100 mg. Genital mycotic infection and osmotic diuresis-related AE rates were higher with canagliflozin; few led to discontinuations. Hypoglycaemia incidence was higher with canagliflozin. Canagliflozin improved glycaemia and reduced body weight vs placebo (week 26) and sitagliptin (week 52) and was generally well tolerated in patients with type 2 diabetes on metformin. ClinicalTrials.gov NCT01106677 This study was supported by Janssen Research & Development, LLC.
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      headline:Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial
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      name:Janssen Research & Development, LLC, Raritan, USA
      name:Janssen Research & Development, LLC, Raritan, USA
      name:Janssen Research & Development, LLC, Raritan, USA
      name:Janssen Research & Development, LLC, Raritan, USA

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