Trial reportDiabetes, obesity & metabolism2018
Long-term safety and efficacy of tofogliflozin as add-on to insulin in patients with type 2 diabetes: Results from a 52-week, multicentre, randomized, double-blind, open-label extension, Phase 4 study in Japan (J-STEP/INS).
Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02201004 (A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus
Who cites it
20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Risk of diabetic ketoacidosis of SGLT2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2023Pooled it
- Risk of hypovolemia associated with sodium-glucose cotransporter-2 inhibitors treatment: A meta-analysis of randomized controlled trials.Frontiers in cardiovascular medicine · 2022Pooled it
- Systematic Review of Literature Examining Bacterial Urinary Tract Infections in Diabetes.Journal of diabetes research · 2022Pooled it
- Pooled it
- Efficacy and safety of empagliflozin as add-on to insulin in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial.Diabetes, obesity & metabolism · 2020Trial
- Baseline Glycated Hemoglobin Values Predict the Magnitude of Glycemic Improvement in Patients with Type 1 and Type 2 Diabetes: Subgroup Analyses from the DIAMOND Study Program.Diabetes technology & therapeutics · 2018Trial
- Long-term safety and efficacy of tofogliflozin as add-on to insulin in patients with type 2 diabetes: Results from a 52-week, multicentre, randomized, double-blind, open-label extension, Phase 4 study in Japan (J-STEP/INS).Diabetes, obesity & metabolism · 2018Trial
- Effects of Tofogliflozin and Anagliptin Alone or in Combination on Glucose Metabolism and Atherosclerosis-Related Markers in Patients with Type 2 Diabetes Mellitus.Clinical pharmacology : advances and applications · 2023Article
- Effects of Sodium-Glucose Cotransporter-2 Inhibitors on Weight in Type 2 Diabetes Mellitus and Therapeutic Regimen Recommendation.Journal of diabetes research · 2022Article
- Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus treated in real-world clinical practice: Results of a 36-month post-marketing surveillance study (J-STEP/LT).Journal of diabetes investigation · 2021Observational
- Japanese Clinical Practice Guideline for Diabetes 2019.Journal of diabetes investigation · 2020Article
- Japanese Clinical Practice Guideline for Diabetes 2019.Diabetology international · 2020Review
- Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A subanalysis of a post-marketing study (J-STEP/EL Study).Journal of diabetes investigation · 2020Observational
- Use of SGLT-2 Inhibitors in Patients with Type 2 Diabetes Mellitus and Abdominal Obesity: An Asian Perspective and Expert Recommendations.Diabetes & metabolism journal · 2020Review
- Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world practice: Results of 12-month interim analysis of a long-term post-marketing surveillance study (J-STEP/LT).Journal of diabetes investigation · 2020Observational
- SGLT2 Inhibitors: A Review of Their Antidiabetic and Cardioprotective Effects.International journal of environmental research and public health · 2019Review
- Combination Therapy with Empagliflozin and Insulin Results in Successful Glycemic Control: A Case Report of Uncontrolled Diabetes Caused by Autoimmune Pancreatitis and Subsequent Steroid Treatment.Case reports in endocrinology · 2019Article
- An Effective Insulin Therapy in Combination With Sodium-Glucose Cotransporter 2 Inhibitors.Journal of clinical medicine research · 2019Article
- Residual Effect of Sodium Glucose Cotransporter 2 Inhibitor, Tofogliflozin, on Body Weight After Washout in Japanese Men With Type 2 Diabetes.Journal of clinical medicine research · 2019Article
- Is there a distinct phenotype of diabetic patients who benefit from tofogliflozin?Archives of medical sciences. Atherosclerotic diseases · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate the long-term safety and efficacy of tofogliflozin as an add-on treatment to insulin over 52 weeks. MATERIALS AND
methodsThis 52-week, multicentre, Phase 4 study consisted of a 16-week, randomized, double-blind, placebo-controlled phase and a 36-week open label extension phase (NCT02201004). Japanese patients with type 2 diabetes mellitus, aged 20 to 75 years, with suboptimal glycaemic control (7.5%-10.5%) receiving insulin monotherapy (basal-bolus, bolus, premix [low and high] and basal) or receiving combination therapy with basal insulin and dipeptidyl peptidase-4 inhibitor were eligible for participation. Patients who received tofogliflozin throughout the study (52 weeks) were referred to as the 'tofo-tofo group' and patients who received placebo and tofogliflozin (36 weeks) were referred to as the 'pla-tofo group'.
resultsA total of 210 patients received treatment per randomization. Hypoglycaemia was the most common treatment-emergent adverse event (AE) (42.9% in the tofo-tofo group and 29.4% in the pla-tofo group). Patients reported genital infection, urinary tract infection, excessive urination and AEs related to volume depletion (2.1%, 2.1%, 7.1% and 10.0% of patients in the tofo-tofo group, and 0%, 1.5%, 2.9% and 7.4% of patients in the pla-tofo group, respectively). Mean HbA1c and body weight at baseline (mean changes ± standard error from baseline to Week 52) in the tofo-tofo and pla-tofo groups were 8.53% (-0.76% ± 0.077) and 8.40% (-0.73% ± 0.102); 68.84 kg (-1.52 kg ± 0.207) and 72.24 kg (-2.13 kg ± 0.313), respectively.
conclusionsThis study demonstrates the safety and efficacy of tofogliflozin as add-on to insulin therapy in type 2 diabetes mellitus patients, offering a new therapeutic solution to diabetes management.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.