Trial Outcomes & Findings for Effects of Antidiabetic Medications on the Postprandial State in Prediabetes (NCT NCT02104739)

Results Overview

Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

baseline

Results posted on

2018-07-03

Participant Flow

21 subjects were enrolled. 20 were randomized, and these 20 participated in each of three arms (the exenatide, saxagliptin, and placebo arms), with the order of receipt being randomized. There was an extension phase (that is, the exenatide extended-release (ER) arm) in which 8 of the 21 enrolled participated.

Participant milestones

Participant milestones
Measure	Exenatide, Then Saxagliptin, Then Placebo Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks	Exenatide, Then Placebo, Then Saxagliptin Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks	Saxagliptin, Then Exenatide, Then Placebo Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks	Saxagliptin, Then Placebo, Then Exenatide Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks	Placebo, Then Saxagliptin, Then Exenatide Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks	Exenatide Extended-release (Extension Phase) Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
First Intervention (1 Day) STARTED	2	5	2	8	3	0
First Intervention (1 Day) COMPLETED	2	4	2	7	3	0
First Intervention (1 Day) NOT COMPLETED	0	1	0	1	0	0
Washout (Min of 10 and Max of 107 Days) STARTED	1	4	2	7	2	0
Washout (Min of 10 and Max of 107 Days) COMPLETED	1	4	2	7	2	0
Washout (Min of 10 and Max of 107 Days) NOT COMPLETED	0	0	0	0	0	0
Second Intervention (1 Day) STARTED	1	4	2	7	2	0
Second Intervention (1 Day) COMPLETED	1	4	2	7	2	0
Second Intervention (1 Day) NOT COMPLETED	0	0	0	0	0	0
Third Intervention (1 Day) STARTED	1	4	2	7	2	0
Third Intervention (1 Day) COMPLETED	1	4	2	7	2	0
Third Intervention (1 Day) NOT COMPLETED	0	0	0	0	0	0
Washout (Min of 10 and Max of 323 Days) STARTED	0	0	0	0	0	8
Washout (Min of 10 and Max of 323 Days) COMPLETED	0	0	0	0	0	7
Washout (Min of 10 and Max of 323 Days) NOT COMPLETED	0	0	0	0	0	1
Extension Phase (6 Weeks) STARTED	0	0	0	0	0	8
Extension Phase (6 Weeks) COMPLETED	0	0	0	0	0	7
Extension Phase (6 Weeks) NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Height is reported for those who participated in the three main arms of the study (exenatide, saxagliptin, and placebo arms) but not separately reported for the extension study (extended-release exenatide). All those who participated in the extension study also participated in the three main arms of the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=16 Participants This was a crossover study in which the 21 who were enrolled participated in each of three arms (the exenatide, saxagliptin, and placebo arms). There was an extension phase (that is, the exenatide extended-release (ER) arm) in which 8 of the 21 enrolled participated. Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
Age, Continuous	50 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants
Height	1.7 meters STANDARD_DEVIATION 0.11 • n=5 Participants • Height is reported for those who participated in the three main arms of the study (exenatide, saxagliptin, and placebo arms) but not separately reported for the extension study (extended-release exenatide). All those who participated in the extension study also participated in the three main arms of the study.
Weight	93.96 kilograms STANDARD_DEVIATION 11.98 • n=5 Participants • Weight is reported for those who participated in the three main arms of the study (exenatide, saxagliptin, and placebo arms) but not separately reported for the extension study (extended-release exenatide). All those who participated in the extension study also participated in the three main arms of the study.
Body Mass Index (BMI)	32.53 kilograms per meter squared STANDARD_DEVIATION 1.92 • n=5 Participants • BMI is reported for those who participated in the three main arms of the study (exenatide, saxagliptin, and placebo arms) but not separately reported for the extension study (extended-release exenatide). All those who participated in the extension study also participated in the three main arms of the study.

PRIMARY outcome

Timeframe: baseline

Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.

Outcome measures

Outcome measures
Measure	Exenatide n=16 Participants Exenatide: Single subcutaneous injection (10 mcg)	Saxagliptin n=16 Participants Saxagliptin: Single dose orally (5 mg)	Placebo n=16 Participants Placebo: Placebo tablets and Placebo (normal saline) injections	Exenatide Extended-release (ER) n=7 Participants Exenatide extended-release (ER): Subcutaneous injection (2mg) weekly for 6 weeks
Monocyte NfkB Levels as Detected by Western Blotting	62.79 NfkB p65 arbitrary units Standard Error 4.05	72.03 NfkB p65 arbitrary units Standard Error 6.38	67.68 NfkB p65 arbitrary units Standard Error 6.38	84.19 NfkB p65 arbitrary units Standard Error 6.45

PRIMARY outcome

Timeframe: 2 hours after ingestion of meal

Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.