Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04432090
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2020-06-09
Brief Title:
GPR119 Agonist for Hypoglycemia in Type 1 Diabetes
Sponsor:
AdventHealth Translational Research Institute
Organization:
AdventHealth Translational Research Institute
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blinded Cross-over Study of the Pharmacologic Action of a GPR119 Agonist on Glucagon Counter-regulation During Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHROG
Brief Summary:
The purpose of this study is to test if a specific research medication could increase the response to low blood glucose in people with type 1 diabetes The response of the body to low blood sugar will be measured in healthy people as a reference point
Detailed Description:
This is a placebo-controlled double-blinded within-subject cross-over phase 2a study In randomized order Latin square randomly assigned to placebo-active and active-placebo periods and in a double-blinded manner the participants with T1D received 14 days of daily dosing with MBX-2982 or placebo taken at the same time each day after breakfast The last dose of treatmentplacebo was given when the glucose tracer infusion for the euglycemichypoglycemic-glucose clamp started Participants with T1D underwent two euglycemic-hypoglycemic clamps induction of controlled hypoglycemia by an insulin infusion using a within-subject cross-over design with the two clamps separated by approximately four weeks that is two weeks of drug washout followed by two weeks of treatment with the alternative therapy Glucagon hepatic glucose production and other counter-regulatory hormonal responses were assessed during hypoglycemia After completion of the first clamp study participants did not receive any study medication for two weeks washout phase and then begin 14 days of the other arm placebo or MBX-2982 in a double-blinded manner followed by a repeat euglycemic-hypoglycemic clamp study During treatment on each arm and during wash out phase a blinded CGM was used to assess daily and nocturnal patterns of glycemia On the day preceding a clamp study while admitted to the research unit a standardized meal test was used to assess fasting and postprandial glucagon GLP-1 and GIP secretion A healthy normal volunteer cohort with no diabetes was enrolled in the study for 14 days for comparison of normal responses to insulin induced hypoglycemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None