scholarly journals MP489RENOPROTECTIVE EFFECT OF SGLT2 INHIBITOR DAPAGLIFLOZIN IN TYPE- 1 DIABETES

2017 ◽  
Vol 32 (suppl_3) ◽  
pp. iii608-iii608
Author(s):  
Dora Balogh ◽  
Judit Hodrea ◽  
Lilla Lenart ◽  
Adam Hosszu ◽  
Edgar Szkibinszkij ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Sglt2 Inhibitor

Fifty-Two-Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Adults with Type 1 Diabetes (inTandem1)

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 212-OR ◽  
Author(s):  
JOHN B. BUSE ◽  
SATISH K. GARG ◽  
JULIO ROSENSTOCK ◽  
TIMOTHY S. BAILEY ◽  
PHILLIP L. BANKS ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Sglt2 Inhibitor ◽  
Efficacy And Safety ◽  
Adjunct Therapy

scholarly journals Case Reports That Illustrate the Efficacy of SGLT2 Inhibitors in the Type 1 Diabetic Patient

2015 ◽  
Vol 2015 ◽  
pp. 1-4 ◽  
Author(s):  
David S. H. Bell
Keyword(s):  
Type 2 Diabetes ◽  
Type 1 Diabetes ◽  
Case Reports ◽  
Sglt2 Inhibitor ◽  
Sglt2 Inhibitors ◽  
Endogenous Insulin ◽  
Large Randomized Clinical Trial ◽  
Endogenous Insulin Production

SGLT2 inhibitors are only approved for use in adults with type 2 diabetes. However, because SGLT2 inhibitors have a mechanism of action that does not require the presence of endogenous insulin, these drugs should also be efficacious in type 1 diabetes where endogenous insulin production is greatly reduced or absent. Herein, I present five cases which illustrate the benefits of utilizing an SGLT2 inhibitor with type 1 diabetes. In these cases the use of SGLT2 inhibitors resulted not only in better glycemic control in most patients but also in some patients’ less hypoglycemia, weight loss, and decreased doses of insulin. In type 1 diabetesCandida albicansvaginitis and balanitis may occur more frequently than in type 2 diabetes. These cases show that a large randomized clinical trial of SGLT2 inhibitors in type 1 diabetes needs to be performed.

scholarly journals Multicenter, Open-Label, 2-Arm, Pilot Trial for Safe Reduction of Basal Insulin Dose Combined with SGLT2 Inhibitor in Type 1 Diabetes Mellitus: Study Protocol for a RISING-STAR Trial

2021 ◽  
Vol 14 ◽  
pp. 117955142110405
Author(s):  
Masahide Hamaguchi ◽  
Yoshitaka Hashimoto ◽  
Toru Tanaka ◽  
Goji Hasegawa ◽  
Michiyo Ishii ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Sample Size ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Sglt2 Inhibitor ◽  
Open Label ◽  
Group B

Background: The safe method of instructing insulin dose reduction in combination with SGLT2 inhibitors, dapagliflozin for patients with type 1 diabetes mellitus has not been clarified. In this study, we conducted a stratified, 2-arm, parallel comparative study with the primary endpoint of decreasing the frequency of hypoglycemia by instructing basal insulin dose reduction. Methods: The study has a multicenter, open-label, 2-arm design; 60 type 1 diabetes mellitus patients are being recruited from 7 hospitals. Study subjects have been stratified into 2 groups based on the ratio of basal insulin daily dose (Basal) to total daily insulin dose (TDD). The subjects whose Basal/TDD ratio is <0.4 are instructed not to reduce Basal but to reduce bolus insulin dose by 10% (group A), and subjects with a Basal/TDD ratio >0.4 will be instructed to reduce Basal by 10% (group B). The primary outcome is the daily frequency of hypoglycemia during the intervention period (SGLT2 inhibitor administration), as determined by self-monitoring of blood glucose. We aimed to confirm a greater reduction in frequency of hypoglycemia in group B (reduced Basal), than in group A (non-reduction of Basal and reduced insulin effect levels by 10%). Baseline hypoglycemia was set at 7 ± 6 times/month. The minimum sample size required to achieve a significance of .05 for a 1-sided t-test with a statistical power at 80% is determined. When the sample size is 26 patients in 1 group, the percentage increase in hypoglycemia exceeds 60%, and the sample size is considered sufficient. Discussion: In this pilot study, we assumed that, given a sufficient Basal, hypoglycemia would be more frequent in patients with type 1 diabetes when combined with SGLT2 inhibitors, provided the Basal was not reduced.

scholarly journals Realworld‐Data of 12‐Month Adjunct SGLT2‐Inhibitor Treatment in Type 1 Diabetes from the German/Austrian DPV Registry: Improved HbA1c without DKA

2021 ◽  
Author(s):  
Jochen Seufert ◽  
Stefanie Lanzinger ◽  
Thomas Danne ◽  
Peter Bramlage ◽  
Sebastian M. Schmid ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Sglt2 Inhibitor ◽  
Inhibitor Treatment

Suppression of Ketogenesis in Type 1 Diabetes Is Not Delayed by SGLT2 Inhibitor Therapy

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 117-LB
Author(s):  
STEPHAN SIEBEL ◽  
NEHA S. PATEL ◽  
ALFONSO GALDERISI ◽  
LORI R. CARRIA ◽  
WILLIAM V. TAMBORLANE ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Sglt2 Inhibitor ◽  
Inhibitor Therapy

scholarly journals Exploring the Potential of the SGLT2 Inhibitor Dapagliflozin in Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Diabetes Care ◽  
2014 ◽  
Vol 38 (3) ◽  
pp. 412-419 ◽  
Author(s):  
Robert R. Henry ◽  
Julio Rosenstock ◽  
Steven Edelman ◽  
Sunder Mudaliar ◽  
Alexandros-Georgios Chalamandaris ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Pilot Study ◽  
Sglt2 Inhibitor ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals SGLT2 Inhibition Increases Fasting Glucagon but Does Not Restore the Counterregulatory Hormone Response to Hypoglycemia in Participants with Type 1 Diabetes

2021 ◽  
Author(s):  
Schafer C. Boeder ◽  
Justin M. Gregory ◽  
Erin R. Giovannetti ◽  
Jeremy H. Pettus
Keyword(s):  
Type 1 Diabetes ◽  
Cell Function ◽  
Sglt2 Inhibitor ◽  
Treatment Phase ◽  
Glycemic Variability ◽  
Hormone Response ◽  
Double Blind ◽  
Sodium Glucose Cotransporter ◽  
Sglt2 Inhibition

Individuals with type 1 diabetes have an impaired glucagon counterregulatory response to hypoglycemia. Sodium-glucose cotransporter (SGLT) inhibitors increase glucagon concentrations. We evaluated whether SGLT inhibition restores the glucagon counterregulatory hormone response to hypoglycemia. Adults with type 1 diabetes (<i>n</i> = 22) were treated with the SGLT2 inhibitor dapagliflozin (5 mg daily) or placebo for 4 weeks in a randomized, double-blind, crossover study. After each treatment phase, participants underwent a hyperinsulinemic hypoglycemic clamp. Basal glucagon concentrations were 32% higher following dapagliflozin versus placebo, with a median within-participant difference of 2.75 pg/mL (95% CI 1.38-12.6). However, increased basal glucagon levels did not correlate with decreased rates of hypoglycemia, and thus do not appear to be protective in avoiding hypoglycemia. During hypoglycemic clamp, SGLT2 inhibition did not change counterregulatory hormone concentrations, time to recovery from hypoglycemia, hypoglycemia symptoms, or cognitive function. Thus, despite raising basal glucagon concentrations, SGLT inhibitor treatment did not restore the impaired glucagon response to hypoglycemia. We propose that clinical reduction in hypoglycemia associated with these agents is a result of changes in diabetes care (e.g., lower insulin doses or improved glycemic variability) as opposed to a direct, physiologic effect of these medications on alpha cell function.

scholarly journals Multicenter, open-label, two-arm pilot trial for safety reduction of basal insulin dose combined with SGLT2 inhibitor in type 1 diabetes mellitus: A study protocol for RISING-STAR

2020 ◽  
Author(s):  
Masahide Hamaguchi ◽  
Yoshitaka Hashimoto ◽  
Toru Tanaka ◽  
Goji Hasegawa ◽  
Michiyo Ishii ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Sample Size ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Sglt2 Inhibitor ◽  
Open Label ◽  
Group B

Abstract Background SGLT2 inhibitor combined with insulin is a novel therapy for patients with type 1 diabetes mellitus. Without the reduction of basal insulin, hypoglycemia could occur frequently in this therapy. However, ketoacidosis is an undesirable adverse effect in cases with basal insulin reduction. Methods This was a multicenter, open-label, two-arm study. Sixty subjects with type 1 diabetes mellitus were recruited from 7 hospitals. Subjects whose basal insulin daily dose to total daily insulin dose (TDD) ratio was < 0.4 were instructed not to reduce the basal insulin dose but to reduce the bolus insulin dose by 10% (Group A), and subjects with a basal-to-TDD ratio > 0.4 were instructed to reduce the basal insulin dose by 10% (Group B). We hypothesized that the frequency of hypoglycemia would be reduced in Group B. The primary outcome was the frequency of hypoglycemia per day during the intervention period (administration of SGLT2 inhibitor) as determined by self-monitoring of blood glucose (SMBG). The baseline number of hypoglycemic attacks was set at 7 ± 6 times/month. The minimum sample size required to achieve a significance of 0.05 for a one-sided t-test with a statistical power of 80% was determined. When the sample size was 26 patients in one group, the percent increase in hypoglycemia was more than 60%; thus, the sample size was estimated to be sufficient. The secondary outcome was the frequency of ketosis before and after the intervention. We aimed to confirm that the frequency of ketosis does not increase in Group B compared with Group A. The frequency of adverse events, including the frequency of hypoglycemia detected using flash glucose monitoring (FGM), was set as the safety endpoint. Discussion The RISING-STAR study will contribute results from a two-arm randomized trial in which a reduction in basal insulin dose is indicated or no reduction in basal insulin dose is instructed for concomitant use of SGLT2 inhibitors in patients with type 1 diabetes to prevent the development of hypoglycemia.Trial registration Registered with the Japan Registry of Clinical Trials (jRCTs051190114) on March 2, 2020.

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