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Effect of Oral CNSA-001 (sepiapterin, PTC923) on gastric accommodation in women with diabetic gastroparesis: A randomized, placebo-controlled, Phase 2 trial
- Source :
- Journal of diabetes and its complications. 35(9)
- Publication Year :
- 2021
-
Abstract
- Aims Diabetic gastroparesis may be associated with impaired nitric oxide metabolism and reduced tetrahydrobiopterin (BH4) synthesis. Oral treatment with CNSA-001 (sepiapterin, currently known as PTC923) increased BH4 levels in humans in a previous study. This Phase 2 study evaluated CNSA-001 in women with diabetic gastroparesis. Methods Non-pregnant diabetic women with moderate/severe symptomatic gastroparesis, delayed gastric emptying, and impaired gastric accommodation (nutrient satiety testing) were randomized to 10 mg/kg BID CNSA-001 or matching placebo for 14 days. The primary endpoint was change in gastric accommodation (maximal tolerated liquid meal volume) at 14- and 28-days' follow-up. Results Gastric accommodation improved in CNSA-001-treated vs. placebo-treated subjects at 28 days (least squares mean [LSM] difference: 98 [95% CI 36 to 161], p = 0.0042). Subjects' ratings of bloating, fullness, nausea, and pain were lower vs. baseline in the CNSA-001 group at 14 and 28 days, though these improvements were not observed consistently in placebo-treated subjects. There were no significant group differences in upper gastrointestinal symptom scores, and in gastric emptying breath test parameters. CNSA-001 was well tolerated, with no withdrawals for adverse events. Conclusions CNSA-001 improved gastric accommodation in women with diabetic gastroparesis. Further evaluation of CNSA-001 in gastroparesis is warranted; ClinicalTrials.gov number, NCT03712124 .
- Subjects :
- medicine.medical_specialty
Gastroparesis
Nausea
Endocrinology, Diabetes and Metabolism
030209 endocrinology & metabolism
030204 cardiovascular system & hematology
Placebo
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Endocrinology
Bloating
Diabetic Neuropathies
Internal medicine
Diabetes mellitus
Internal Medicine
Clinical endpoint
Diabetes Mellitus
Medicine
Humans
Breath test
Gastric emptying
medicine.diagnostic_test
business.industry
medicine.disease
Pterins
Gastric Emptying
Female
medicine.symptom
business
Subjects
Details
- ISSN :
- 1873460X
- Volume :
- 35
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Journal of diabetes and its complications
- Accession number :
- edsair.doi.dedup.....fcf24e378ac9c6ae7c82bbfc50600f36