GLP ‐1 Receptor Agonists as Adjunctive Treatment for Type 1 Diabetes: Renewed Opportunities through Tailored Approaches?

2022 ◽  
Author(s):  
Alessandra Kobayati ◽  
Ahmad Haidar ◽  
Michael A. Tsoukas
Keyword(s):  
Type 1 Diabetes ◽  
Adjunctive Treatment ◽  
Receptor Agonists

GLP-1 receptor agonists in type 1 diabetes: a proof-of-concept approach

2015 ◽  
Vol 52 (6) ◽  
pp. 1129-1133 ◽  
Author(s):  
Isabella Crisci ◽  
Michele Aragona ◽  
Konstantina Savvina Politi ◽  
Giuseppe Daniele ◽  
Stefano Del Prato
Keyword(s):  
Type 1 Diabetes ◽  
Proof Of Concept ◽  
Receptor Agonists

scholarly journals The SimpliciT1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Adaptive Study of TTP399, a Hepatoselective Glucokinase Activator, for Adjunctive Treatment of Type 1 Diabetes

2021 ◽  
Author(s):  
Klara R. Klein ◽  
Jennifer L. R. Freeman ◽  
Imogene Dunn ◽  
Chris Dvergsten ◽  
M. Sue Kirkman ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Adjunctive Treatment ◽  
Study Phase ◽  
Double Blind ◽  
Glucokinase Activator ◽  
Phase 1B ◽  
The Difference

<b>Objective</b> <p>Despite advances in exogenous insulin therapy, many patients with type 1 diabetes do not achieve acceptable glycemic control and remain at risk for ketosis and insulin-induced hypoglycemia. We conducted a randomized controlled trial to determine whether TTP399, a novel hepatoselective glucokinase activator, improved glycemic control in people with type 1 diabetes without increasing hypoglycemia or ketosis. </p> <p><b>Research design and methods</b></p> <p>SimpliciT1 was a Phase 1b/2 adaptive study. Phase 2 activities were conducted in 2 parts. Part 1 randomized 20 participants using continuous glucose monitors (CGM) and continuous subcutaneous insulin infusion (CSII). Part 2 randomized 85 participants on multiple daily injections of insulin or CSII. In both Part 1 and 2, participants were randomized to TTP399 800 mg or matched placebo (fully blinded) and treated for 12-weeks. The primary endpoint was the change in HbA1c from baseline to week 12.</p> <p><b>Results</b></p> <p>The difference in the change in HbA1c from baseline to week 12 between TTP399 and placebo was -0.7% (95% CI -1.3, -0.07) in Part 1 and -0.21 (95% CI -0.39, -0.04) in Part 2. Despite a greater decrease in HbA1c with TTP399, the frequency of severe or symptomatic hypoglycemia decreased by 40% relative to placebo in Part 2. In both Part 1 and Part 2, plasma beta-hydroxybutrate and urinary ketones were lower during treatment with TTP399 than placebo. </p> <p><b>Conclusions</b></p> <p>TTP399 lowers HbA1c and reduces hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes.</p>

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