Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: SimpliciT1 was a phase 1b/2 adaptive study. Phase 2 activities were conducted in two parts. Part 1 randomly assigned 20 participants using continuous glucose monitors and continuous subcutaneous insulin infusion (CSII). Part 2 randomly assigned 85 participants receiving multiple daily injections of insulin or CSII. In both parts 1 and 2, participants were randomly assigned to 800 mg TTP399 or matched placebo (fully blinded) and treated for 12 weeks. The primary end point was change in HbA1c from baseline to week 12. RESULTS: The difference in 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 parts 1 and 2, plasma β-hydroxybutyrate and urinary ketones were lower during treatment with TTP399 than placebo. CONCLUSIONS:
|
Authors | Klara R Klein, Jennifer L R Freeman, Imogene Dunn, Chris Dvergsten, M Sue Kirkman, John B Buse, Carmen Valcarce, SimpliciT1 research group |
Journal | Diabetes care
(Diabetes Care)
Vol. 44
Issue 4
Pg. 960-968
(04 2021)
ISSN: 1935-5548 [Electronic] United States |
PMID | 33622669
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
|
Copyright | © 2021 by the American Diabetes Association. |
Chemical References |
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- Organic Chemicals
- TTP399
- Glucokinase
|
Topics |
- Diabetes Mellitus, Type 1
(drug therapy)
- Double-Blind Method
- Glucokinase
- Glycated Hemoglobin
(analysis)
- Humans
- Hypoglycemic Agents
(adverse effects)
- Insulin
- Organic Chemicals
- Treatment Outcome
|