Trial Outcomes & Findings for Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes (NCT NCT01364584)

NCT ID: NCT01364584

Last Updated: 2023-07-12

Results Overview

Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline and 3 months
• Results posted on: 2023-07-12

Participant Flow

Participant milestones

Measure	Exenatide Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes

Baseline characteristics by cohort

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID	Total n=23 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 7 • n=5 Participants	64 years STANDARD_DEVIATION 1 • n=7 Participants	64 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Body Mass (kg)	101.7 kilograms STANDARD_DEVIATION 5.3 • n=5 Participants	87.9 kilograms STANDARD_DEVIATION 3.3 • n=7 Participants	93.4 kilograms STANDARD_DEVIATION 16.1 • n=5 Participants
Body Mass Index (kg/m2)	33.9 kilograms per meter squared STANDARD_DEVIATION 1.0 • n=5 Participants	31.3 kilograms per meter squared STANDARD_DEVIATION 1.2 • n=7 Participants	32.3 kilograms per meter squared STANDARD_DEVIATION 3.9 • n=5 Participants
Body Fat (%)	37.7 percentage STANDARD_DEVIATION 2.3 • n=5 Participants	35.7 percentage STANDARD_DEVIATION 2.2 • n=7 Participants	36.7 percentage STANDARD_DEVIATION 7.15 • n=5 Participants
Lean Mass (kg)	61.9 kilograms STANDARD_DEVIATION 3.9 • n=5 Participants	55.8 kilograms STANDARD_DEVIATION 2.8 • n=7 Participants	58.1 kilograms STANDARD_DEVIATION 11.6 • n=5 Participants
Fasting Glucose (mg/dl)	170.5 milligrams per deciliter STANDARD_DEVIATION 24.2 • n=5 Participants	127.9 milligrams per deciliter STANDARD_DEVIATION 8.0 • n=7 Participants	147.6 milligrams per deciliter STANDARD_DEVIATION 59.9 • n=5 Participants
Fasting Insulin (μU/ml)	29.0 microunits per milliliter STANDARD_DEVIATION 3.7 • n=5 Participants	34.6 microunits per milliliter STANDARD_DEVIATION 6.4 • n=7 Participants	31.0 microunits per milliliter STANDARD_DEVIATION 15.1 • n=5 Participants
HbA1c (%)	7.3 percentage of glycated hemoglobin STANDARD_DEVIATION 1.1 • n=5 Participants	7.2 percentage of glycated hemoglobin STANDARD_DEVIATION 0.4 • n=7 Participants	7.2 percentage of glycated hemoglobin STANDARD_DEVIATION 1.1 • n=5 Participants
Total Cholesterol (mg/dl)	156.3 milligrams per deciliter STANDARD_DEVIATION 9.8 • n=5 Participants	175.3 milligrams per deciliter STANDARD_DEVIATION 11.7 • n=7 Participants	165.2 milligrams per deciliter STANDARD_DEVIATION 34.9 • n=5 Participants
LDL Cholesterol (mg/dl)	93.8 milligrams per deciliter STANDARD_DEVIATION 6.2 • n=5 Participants	97.6 milligrams per deciliter STANDARD_DEVIATION 7.4 • n=7 Participants	94.4 milligrams per deciliter STANDARD_DEVIATION 22.1 • n=5 Participants
Triglycerides (mg/dl)	156.8 milligrams per deciliter STANDARD_DEVIATION 18.3 • n=5 Participants	217.8 milligrams per deciliter STANDARD_DEVIATION 58.0 • n=7 Participants	190.1 milligrams per deciliter STANDARD_DEVIATION 136.9 • n=5 Participants
Glycerol (mg/dl)	1.21 milligrams per deciliter STANDARD_DEVIATION 0.5 • n=5 Participants	1.14 milligrams per deciliter STANDARD_DEVIATION 0.5 • n=7 Participants	1.16 milligrams per deciliter STANDARD_DEVIATION 0.5 • n=5 Participants
Free Fatty Acids (mmol/L)	580.8 millimoles per liter STANDARD_DEVIATION 76.3 • n=5 Participants	500.5 millimoles per liter STANDARD_DEVIATION 67.8 • n=7 Participants	546.3 millimoles per liter STANDARD_DEVIATION 228.2 • n=5 Participants
VO2peak (ml/kg/min)	17.5 milliliters per kilogram per minute STANDARD_DEVIATION 1.0 • n=5 Participants	15.4 milliliters per kilogram per minute STANDARD_DEVIATION 0.9 • n=7 Participants	16.4 milliliters per kilogram per minute STANDARD_DEVIATION 3.1 • n=5 Participants
VO2peak (ml/min)	1783 milliliters per minute STANDARD_DEVIATION 129 • n=5 Participants	1363 milliliters per minute STANDARD_DEVIATION 95 • n=7 Participants	1554 milliliters per minute STANDARD_DEVIATION 415 • n=5 Participants
VO2 kinetics tau (sec)	78.2 seconds STANDARD_DEVIATION 6.8 • n=5 Participants	63.3 seconds STANDARD_DEVIATION 5.9 • n=7 Participants	71.9 seconds STANDARD_DEVIATION 19.1 • n=5 Participants
Circumferential Strain	-23.7 percentage difference in circumferences STANDARD_DEVIATION 5.5 • n=5 Participants	-23.5 percentage difference in circumferences STANDARD_DEVIATION 5.0 • n=7 Participants	-23.6 percentage difference in circumferences STANDARD_DEVIATION 5.3 • n=5 Participants
Longitudinal Strain	-17.1 percentage difference in lengths STANDARD_DEVIATION 3.9 • n=5 Participants	-19.3 percentage difference in lengths STANDARD_DEVIATION 2.3 • n=7 Participants	-18.2 percentage difference in lengths STANDARD_DEVIATION 3.4 • n=5 Participants
Stroke Volume (ml/beat)	79.2 milliliters per beat STANDARD_DEVIATION 22.7 • n=5 Participants	82.5 milliliters per beat STANDARD_DEVIATION 23.1 • n=7 Participants	81.5 milliliters per beat STANDARD_DEVIATION 23.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Peak Oxygen Consumption (VO2 Peak)	16.6 milliliters per kilogram per minute Standard Deviation 1.1	16.1 milliliters per kilogram per minute Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline and 3 months

Time to steady state oxygen consumption will be assessed in subject before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Oxygen Uptake Kinetics Steady State Tau	71.4 seconds Standard Deviation 8.5	67.2 seconds Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Data unable to be collected on all participants, hence the difference between the overall number of participants analyzed here and the actual number of participants who completed the study

Pulse wave velocity will be measured via sphygmocor before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=6 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=7 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Change From Baseline in Arterial Stiffness	-1.23 meters/second Standard Deviation 1.27	0.37 meters/second Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline and 3 months

Change in the response of the brachial artery to hyperemia will be assessed before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Change From Baseline in Peak Dilation of Brachial Artery Diameter Pre-Intervention (Baseline)	0.193 millimeters Standard Deviation 0.045	0.192 millimeters Standard Deviation 0.046
Change From Baseline in Peak Dilation of Brachial Artery Diameter Post-Intervention (3 months)	0.226 millimeters Standard Deviation 0.057	0.151 millimeters Standard Deviation 0.026

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Data not collected

Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Circumferential Strain	-25.6 % difference in circumferences Standard Deviation 1.78	-22.6 % difference in circumferences Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Longitudinal Strain	-18.5 % difference in lengths Standard Deviation 1.2	-18.3 % difference in lengths Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Stroke Volume	93.3 mL/beat Standard Deviation 2.8	80.7 mL/beat Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Mitral Valve E Wave Velocity	0.61 centimeters/second Standard Deviation 0.06	0.78 centimeters/second Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Mitral Valve E:A Wave Velocity	0.85 centimeters/second Standard Deviation 0.09	0.82 centimeters/second Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Mitral Valve Deceleration Time	234.6 milliseconds Standard Deviation 17.0	239.8 milliseconds Standard Deviation 14.6

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Septal E'	0.08 centimeters/second Standard Deviation 0.01	0.07 centimeters/second Standard Deviation 0.01

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Septal E:E'	8.3 ratio Standard Deviation 0.9	12.6 ratio Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Lateral E'	0.09 centimeters/second Standard Deviation 0.01	0.09 centimeters/second Standard Deviation 0.01

SECONDARY outcome

Timeframe: Baseline and 3 months

Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.

Outcome measures

Measure	Exenatide n=11 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 Participants Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Echocardiographic Measures - Lateral E:E'	6.7 ratio Standard Deviation 0.6	8.4 ratio Standard Deviation 1.2

Adverse Events

Exenatide

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exenatide n=11 participants at risk Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)	Placebo n=12 participants at risk Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID
Renal and urinary disorders Renal Neoplasm (Tumor on base of kidney)	9.1% 1/11	0.00% 0/12
Blood and lymphatic system disorders Eosinophil count increased	9.1% 1/11	0.00% 0/12
Renal and urinary disorders Bladder Papilloma	9.1% 1/11	0.00% 0/12

Other adverse events

Adverse event data not reported

Additional Information

Judith G Regensteiner, PhD

University of Colorado School of Medicine

Phone: 303-724-2247

Email: judy.regensteiner@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place