Trial reportDiabetologia2016
Metabolic consequences of acute and chronic empagliflozin administration in treatment-naive and metformin pretreated patients with type 2 diabetes.
Trial report in Diabetologia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01248364 (An Open-label, Phase II Study to Determine Acute), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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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.
An Open-label, Phase II Study to Determine Acute (After the First Dose Administration) and Chronic (After 28 Days of Treatment) Effects of the Sodium-glucose Co-transporter-2 (SGLT-2) Inhibitor Empagliflozin (BI 10773) (25 mg Once Daily) on Pre and Postprandial Glucose Homeostasis in Patients With IGT and, Type 2 Diabetes Mellitus and Healthy Subjects
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Empagliflozin reduces diffuse myocardial fibrosis by extracellular volume mapping: A meta-analysis of clinical studies.Frontiers in endocrinology · 2022Pooled it
- Empagliflozin as add-on to linagliptin in a fixed-dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52-week, randomized, placebo-controlled trial.Diabetes, obesity & metabolism · 2018Trial
- SGLT2 inhibition, high-density lipoprotein, and kidney function: a mendelian randomization study.Lipids in health and disease · 2024Article
- A Randomized, Double-Blind, Parallel-Group Phase III Trial Investigating the Glycemic Efficacy and Safety Profile of Fixed-Dose Combination Dapagliflozin and Linagliptin Over Linagliptin Monotherapy in Patients with Inadequately Controlled Type 2 Diabetes with Metformin.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024Article
- The NLRP3 Inflammasome as a Novel Therapeutic Target for Cardiac Fibrosis.Journal of inflammation research · 2022Review
- Real-world evidence for long-term safety and effectiveness of ipragliflozin in treatment-naïve versus non-naïve Japanese patients with type 2 diabetes mellitus: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM).Diabetology international · 2021Article
- The SGLT-2 inhibitor empagliflozin improves myocardial strain, reduces cardiac fibrosis and pro-inflammatory cytokines in non-diabetic mice treated with doxorubicin.Cardiovascular diabetology · 2021Article
- Type 2 diabetes subgroups and potential medication strategies in relation to effects on insulin resistance and beta-cell function: A step toward personalised diabetes treatment?Molecular metabolism · 2021Review
- Sodium-glucose Cotransporter 2 Inhibitors' Rise to the Backbone of Heart Failure Management: A Clinical Review.Heart international · 2021Review
- Sodium-glucose cotransporter-2 inhibitors: Understanding the mechanisms for therapeutic promise and persisting risks.The Journal of biological chemistry · 2020Review
- Rationale for the Early Use of Sodium-Glucose Cotransporter-2 Inhibitors in Patients with Type 2 Diabetes.Advances in therapy · 2019Review
- Dehydration and insulinopenia are necessary and sufficient for euglycemic ketoacidosis in SGLT2 inhibitor-treated rats.Nature communications · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisSodium glucose co-transporter 2 (SGLT2) inhibitors lower glycaemia by inducing glycosuria, but raise endogenous glucose production (EGP). Metformin lowers glycaemia mainly by suppressing EGP. We compared the effects of the SGLT2 inhibitor empagliflozin in treatment-naive (TN) and metformin pretreated (Met) patients with type 2 diabetes.
methodsA total of 32 TN and 34 patients on a stable dose of metformin, two subgroups of a study that we previously reported, received a mixed meal with double-tracer glucose administration and indirect calorimetry at baseline, after a single 25 mg dose of empagliflozin, and after 4 weeks of treatment with empagliflozin 25 mg/day.
resultsAt baseline, compared with the TN group, the Met group had higher fasting glycaemia (9.1 ± 1.7 vs 8.2 ± 1.3 mmol/l), lower fasting and postmeal insulin secretion, lower beta cell glucose sensitivity (37 [18] vs 58 [43] pmol min(-1) m(-2) [mmol/l](-1), median [interquartile range]) and insulin:glucagon ratio, and higher fasting EGP (15.9 [4.3] vs 12.1 [2.7] μmol kgFFM (-1) min(-1)). Change from baseline in fasting EGP after single dose and 4 weeks of treatment with empagliflozin was similar in the Met and TN groups (19.6 [4.2] and 19.0 [2.3] in Met vs 16.2 [3.6] and 15.5 [3.2] μmol kgFFM (-1) min(-1) in TN for acute and chronic dosing, respectively). Beta cell glucose sensitivity increased less in Met than TN patients, whereas substrate utilisation shifted from carbohydrate to fat more in Met than TN patients. CONCLUSIONS/
interpretationAt baseline, Met patients with type 2 diabetes had more advanced disease than TN patients, featuring worse beta cell function and higher EGP. Empagliflozin induced similar glycosuria and metabolic and hormonal responses in Met and TN patients.
trial registrationClinicalTrials.gov NCT01248364; European Union Clinical Trials Register 2010-018708-99.
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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.