Trial Outcomes & Findings for Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery (NCT NCT02443402)

NCT ID: NCT02443402

Last Updated: 2018-02-06

Results Overview

Number of participants who developed stress hyperglycemia (BG \>180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 68 participants
• Primary outcome timeframe: Post-Surgery (Up to 4 Days)
• Results posted on: 2018-02-06

Participant Flow

Participants were recruited from four academic hospitals including Emory University Hospital, Emory Midtown Hospital, Emory Saint Joseph's, and Grady Memorial Hospital in Atlanta, Georgia between January 2016 and October 2016.

Of the 68 participants consented for study participation, seven did not begin study participation after randomization. One participant was a screen failure prior to randomization. All participants that began a study intervention were included in the baseline analysis.

Participant milestones

Measure	Sitagliptin Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Study STARTED	36	31
Overall Study COMPLETED	32	28
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Sitagliptin Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Study Withdrawal by Subject	3	1
Overall Study Screen Failure	1	2

Baseline Characteristics

Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery

Baseline characteristics by cohort

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.	Total n=60 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 11 • n=93 Participants	64 years STANDARD_DEVIATION 9 • n=4 Participants	64 years STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	23 Participants n=4 Participants	47 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Race/Ethnicity, Customized African American	9 Participants n=93 Participants	6 Participants n=4 Participants	15 Participants n=27 Participants
Race/Ethnicity, Customized Other	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	32 Participants n=93 Participants	28 Participants n=4 Participants	60 Participants n=27 Participants

PRIMARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)	22 Participants	25 Participants

PRIMARY outcome

Timeframe: Post-Surgery (Up to 10 Days)

Population: Participants that completed all study assessments.

Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Subjects With Persistent Hyperglycemia	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

The blood glucose levels will be assessed throughout the day using a glucose meter. An average will be calculated. The normal BG range for someone with diabetes is 80-130 mg/dL.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration	137 mg/dL Standard Deviation 16	138 mg/dL Standard Deviation 25

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU. The more insulin given, the more hyperglycemic events experienced.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)	37 units per day Standard Deviation 60	83 units per day Standard Deviation 64

SECONDARY outcome

Timeframe: Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)

Population: Participants that completed all study assessments.

Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Duration of Continuous Intravenous Insulin (CII)	12 hours Interval 5.0 to 88.0	17 hours Interval 9.0 to 80.0

SECONDARY outcome

Timeframe: Post-Surgery (Up to 10 Days)

Population: Participants that completed all study assessments.

Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Mean Units Subcutaneous (SQ) Insulin Required	2.4 units Standard Deviation .5	2.4 units Standard Deviation .9

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU. The normal BG range for someone with diabetes is 80-130 mg/dL.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)	123 mg/dl Standard Deviation 13	124 mg/dl Standard Deviation 16

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

Total amount of insulin glargine insulin (units) administered in the ICU per day.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Total Insulin Therapy in the Intensive Care Unit (ICU)	0 units per day Standard Deviation 0	0 units per day Standard Deviation 0

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 10 Days)

Population: Participants that completed all study assessments.

Number of participants with blood glucose (BG) >180 after transition from ICU.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

Number of participants with blood glucose (BG) <70 during ICU stay.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

Number of participants with blood glucose (BG) <70 after transition from ICU.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of Hospitalization (Up to 30 Days)

Population: Participants that completed all study assessments.

Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Blood Glucose Less Than 40 mg/dl	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 10 Days)

Population: Participants that completed all study assessments.

The total number of subject deaths during hospital stay will be recorded.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Hospital Mortality Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

The total number of subject deaths during ICU stay will be recorded.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Intensive Care Unit (ICU) Mortality Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-Hospital Discharge (Up to 10 Days)

Population: Participants that completed all study assessments.

Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Cerebrovascular Events	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Duration of Hospitalization (Up to 30 days)

Population: Participants that completed all study assessments.

The total number of all complications experienced during hospitalization. Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Hospital Complication Rate	47 number of complications	57 number of complications

SECONDARY outcome

Timeframe: Post-Surgery (Up to 4 Days)

Population: Participants that completed all study assessments.

Number of days in the ICU after coronary artery bypass graft surgery (CABG).

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Length of Stay: Intensive Care Unit (ICU)	2 days Interval 1.0 to 4.0	2 days Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Post-Randomization (Up to 9 days)

Population: Participants that completed all study assessments.

Number of days in the hospital after a participant is randomized to a study intervention.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Length of Hospital Stay After Study Randomization	6.0 days Interval 5.0 to 9.0	6.5 days Interval 4.5 to 8.0

SECONDARY outcome

Timeframe: Post-Hospital Discharge (Up to 30 Days)

Population: Participants that completed all study assessments.

Number of subjects readmitted to the hospital within 30 days due to wound infection.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants Re-admitted to the Hospital Due to Wound Infections	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Post-Hospital Discharge (Up to 30 Days)

Population: Participants that completed all study assessments.

Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants Re-admitted to the Hospital Not Due to Wound Infections	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-Hospital Discharge (Up to 30 Days)

Population: Participants that completed all study assessments.

Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Emergency Room (ER) Visits	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Post-Hospital Discharge (Up to 30 Days)

Population: Participants that completed all study assessments.

Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Participants With Infections Not Requiring Hospital Re-admission	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 2 Days)

Population: Participants that completed all study assessments.

The number of subjects requiring the use of inotropes for >24 hours post CABG.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours	11 Participants	7 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 2 Days)

Population: Participants that completed all study assessments.

The number of subjects requiring re-intubation after CABG.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Subjects Requiring Re-intubation	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 24 Hours)

Population: Participants that completed all study assessments.

The number of subjects requiring re-intubation with 24 after CABG.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Subjects Requiring Re-intubation Within 24 Hours	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Post-Surgery (Up to 10 Days)

Population: Participants that completed all study assessments.

The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.

Outcome measures

Measure	Sitagliptin n=32 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 Participants Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Number of Subject Requiring Surgical Re-Intervention	1 Participants	2 Participants

Adverse Events

Sitagliptin

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sitagliptin n=32 participants at risk Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 participants at risk Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Nervous system disorders Stroke	6.2% 2/32 • Number of events 2 • Adverse events were collected through hospital discharge (up to 30 days).	3.6% 1/28 • Number of events 1 • Adverse events were collected through hospital discharge (up to 30 days).
Injury, poisoning and procedural complications Surgical Site Bleeding	6.2% 2/32 • Number of events 2 • Adverse events were collected through hospital discharge (up to 30 days).	7.1% 2/28 • Number of events 2 • Adverse events were collected through hospital discharge (up to 30 days).
Vascular disorders Deep Vein Thrombosis	3.1% 1/32 • Number of events 1 • Adverse events were collected through hospital discharge (up to 30 days).	0.00% 0/28 • Adverse events were collected through hospital discharge (up to 30 days).
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	12.5% 4/32 • Number of events 4 • Adverse events were collected through hospital discharge (up to 30 days).	14.3% 4/28 • Number of events 4 • Adverse events were collected through hospital discharge (up to 30 days).

Other adverse events

Measure	Sitagliptin n=32 participants at risk Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.	Placebo n=28 participants at risk Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Renal and urinary disorders Acute Kidney Injury	15.6% 5/32 • Number of events 5 • Adverse events were collected through hospital discharge (up to 30 days).	7.1% 2/28 • Number of events 2 • Adverse events were collected through hospital discharge (up to 30 days).
Cardiac disorders Atrial Fibrillation	31.2% 10/32 • Number of events 10 • Adverse events were collected through hospital discharge (up to 30 days).	32.1% 9/28 • Number of events 9 • Adverse events were collected through hospital discharge (up to 30 days).
Cardiac disorders Ventricular Fibrillation	3.1% 1/32 • Number of events 1 • Adverse events were collected through hospital discharge (up to 30 days).	0.00% 0/28 • Adverse events were collected through hospital discharge (up to 30 days).
Cardiac disorders Heart Failure	6.2% 2/32 • Number of events 2 • Adverse events were collected through hospital discharge (up to 30 days).	7.1% 2/28 • Number of events 2 • Adverse events were collected through hospital discharge (up to 30 days).
Infections and infestations Pneumonia	9.4% 3/32 • Number of events 3 • Adverse events were collected through hospital discharge (up to 30 days).	3.6% 1/28 • Number of events 1 • Adverse events were collected through hospital discharge (up to 30 days).
Infections and infestations Urinary Tract Infection	3.1% 1/32 • Number of events 1 • Adverse events were collected through hospital discharge (up to 30 days).	3.6% 1/28 • Number of events 1 • Adverse events were collected through hospital discharge (up to 30 days).

Additional Information

Dr. Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: geumpie@emory.edu

Results disclosure agreements

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