Trial Outcomes & Findings for Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes (NCT NCT04466618)

Results Overview

Concentrations of glucagon Measured by immunoassay over the -30 to 0 minutes of study. On one study day subjects received saline, on the other exendin-9,39. The infusion commenced at -120 minutes.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

23 participants

Primary outcome timeframe

Average concentration over the -30 to 0 minutes of study

Results posted on

2023-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	Non-diabetic Subjects Saline: Saline infused during the study Exendin-9,39: Exendin-9,39 infused during the study In a subset an additional 2 arms: - Saline + Intralipid/Heparin: Saline infused during acute insulin resistance Exendin-9,39 + Intralipid/Heparin: Exendin-9,39 infused during acute insulin resistance	Subjects With Type 2 Diabetes Saline: Saline infused during the study Exendin-9,39: Exendin-9,39 infused during the study
Overall Study STARTED	12	11
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-diabetic Subjects Saline: Saline infused during the study Exendin-9,39: Exendin-9,39 infused during the study In a subset an additional 2 arms: - Saline + Intralipid/Heparin: Saline infused during acute insulin resistance Exendin-9,39 + Intralipid/Heparin: Exendin-9,39 infused during acute insulin resistance	Subjects With Type 2 Diabetes Saline: Saline infused during the study Exendin-9,39: Exendin-9,39 infused during the study
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Diabetes n=12 Participants Subjects without Diabetes	Type 2 Diabetes n=11 Participants Subjects with Type 2 Diabetes	Total n=23 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 8 • n=12 Participants	58 years STANDARD_DEVIATION 5 • n=11 Participants	56 years STANDARD_DEVIATION 7 • n=23 Participants
Sex: Female, Male Female	8 Participants n=12 Participants	8 Participants n=11 Participants	16 Participants n=23 Participants
Sex: Female, Male Male	4 Participants n=12 Participants	3 Participants n=11 Participants	7 Participants n=23 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	11 participants n=11 Participants	23 participants n=23 Participants

PRIMARY outcome

Timeframe: Average concentration over the -30 to 0 minutes of study

Population: 1 patient with type 2 diabetes did not complete one study secondary to loss of IV access

Concentrations of glucagon Measured by immunoassay over the -30 to 0 minutes of study. On one study day subjects received saline, on the other exendin-9,39. The infusion commenced at -120 minutes.