Trial Outcomes & Findings for Cardiovascular Effects of GLP-1 Receptor Activation (NCT NCT03101930)
NCT ID: NCT03101930
Last Updated: 2022-10-18
Results Overview
Brachial artery diameter is measured under basal conditions and during reactive hyperemia (Flow Mediated Dilation as %)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
329 participants
Primary outcome timeframe
Baseline to 2 and 14 weeks
Results posted on
2022-10-18
Participant Flow
CONSORT flow details: * 329 signed consent. * 178 individuals did not meet inclusion/exclusion criteria. * 35 individuals declined to participate. * 23 individuals did not return for subsequent visits. * 93 individuals randomized. * 88 individuals completed study days.
Participant milestones
| Measure |
Liraglutide
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
23
|
24
|
|
Overall Study
COMPLETED
|
44
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Liraglutide
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
Baseline Characteristics
Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 4, Sitaglipin 1, Hypocaloric Diet 3
Baseline characteristics by cohort
| Measure |
Liraglutide
n=46 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=23 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=24 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 9.9 • n=46 Participants
|
52.8 years
STANDARD_DEVIATION 10.5 • n=23 Participants
|
48.9 years
STANDARD_DEVIATION 12.1 • n=24 Participants
|
50.3 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=46 Participants
|
16 Participants
n=23 Participants
|
14 Participants
n=24 Participants
|
63 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=46 Participants
|
7 Participants
n=23 Participants
|
10 Participants
n=24 Participants
|
30 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=46 Participants
|
2 Participants
n=23 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=46 Participants
|
21 Participants
n=23 Participants
|
23 Participants
n=24 Participants
|
88 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=46 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=46 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=46 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=46 Participants
|
4 Participants
n=23 Participants
|
4 Participants
n=24 Participants
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=46 Participants
|
18 Participants
n=23 Participants
|
19 Participants
n=24 Participants
|
75 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=46 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=46 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants
|
23 participants
n=23 Participants
|
24 participants
n=24 Participants
|
93 participants
n=93 Participants
|
|
Flow mediated dilation
|
10.5 Percentage
STANDARD_DEVIATION 5.2 • n=42 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 4, Sitaglipin 1, Hypocaloric Diet 3
|
10.4 Percentage
STANDARD_DEVIATION 5.37 • n=22 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 4, Sitaglipin 1, Hypocaloric Diet 3
|
10.2 Percentage
STANDARD_DEVIATION 5.3 • n=21 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 4, Sitaglipin 1, Hypocaloric Diet 3
|
10.4 Percentage
STANDARD_DEVIATION 5.2 • n=85 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 4, Sitaglipin 1, Hypocaloric Diet 3
|
|
Urine Albumin-Creatinine ratio
|
12.04 mg/g
STANDARD_DEVIATION 23.6 • n=44 Participants • Participants who were randomized to intervention but did not complete study day measurements are not included: Liraglutide 2, Sitagliptin 1, Hypocaloric Diet 2
|
7.85 mg/g
STANDARD_DEVIATION 7.6 • n=22 Participants • Participants who were randomized to intervention but did not complete study day measurements are not included: Liraglutide 2, Sitagliptin 1, Hypocaloric Diet 2
|
6.3 mg/g
STANDARD_DEVIATION 3.8 • n=22 Participants • Participants who were randomized to intervention but did not complete study day measurements are not included: Liraglutide 2, Sitagliptin 1, Hypocaloric Diet 2
|
9.6 mg/g
STANDARD_DEVIATION 17.3 • n=88 Participants • Participants who were randomized to intervention but did not complete study day measurements are not included: Liraglutide 2, Sitagliptin 1, Hypocaloric Diet 2
|
|
Plasminogen Activator Inhibitor-1, plasma
|
20.2 U/mL
STANDARD_DEVIATION 9.2 • n=43 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 3, Sitaglipin 2, Hypocaloric Diet 4
|
18.5 U/mL
STANDARD_DEVIATION 8.6 • n=21 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 3, Sitaglipin 2, Hypocaloric Diet 4
|
18.5 U/mL
STANDARD_DEVIATION 8.0 • n=20 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 3, Sitaglipin 2, Hypocaloric Diet 4
|
19.4 U/mL
STANDARD_DEVIATION 8.7 • n=84 Participants • Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide 3, Sitaglipin 2, Hypocaloric Diet 4
|
PRIMARY outcome
Timeframe: Baseline to 2 and 14 weeksPopulation: Incomplete data due to missed study visits and missing samples in the following time periods/arms (n= number of participants with missing data): * Liraglutide/Placebo: Week 2 (n=5); Week 14 (n=4) * Liraglutide/Exendin: Week 2 (n=11); Week 14 (n=12) * Sitagliptin/Placebo: Week 2 (n=2) * Sitagliptin/Exendin: Week 2 (n=3); Week 14 (n=2) * Diet/Placebo: Week 2 (n=1); Week 14 (n=6) * Diet/Exendin: Week 2 (n=7); Week 14 (n=11)
Brachial artery diameter is measured under basal conditions and during reactive hyperemia (Flow Mediated Dilation as %)
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=22 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Change in Flow-mediated Dilation
Baseline to 2 weeks (Placebo infusion)
|
0.71 Percentage
Standard Deviation 4.82
|
2.06 Percentage
Standard Deviation 6.42
|
1.24 Percentage
Standard Deviation 5.09
|
|
Change in Flow-mediated Dilation
Baseline to 2 weeks (Exendin infusion)
|
0.48 Percentage
Standard Deviation 5.81
|
0.13 Percentage
Standard Deviation 4.49
|
1.43 Percentage
Standard Deviation 7.09
|
|
Change in Flow-mediated Dilation
Baseline to 14 weeks (Placebo infusion)
|
1.43 Percentage
Standard Deviation 5.33
|
1.59 Percentage
Standard Deviation 5.74
|
1.01 Percentage
Standard Deviation 5.38
|
|
Change in Flow-mediated Dilation
Baseline to 14 weeks (Exendin infusion)
|
1.73 Percentage
Standard Deviation 5.22
|
1.42 Percentage
Standard Deviation 5.88
|
0.42 Percentage
Standard Deviation 4.28
|
PRIMARY outcome
Timeframe: Baseline to 13 weeksPopulation: Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide: 2 participants; Diet: 6 participants
Ratio of urine albumin to creatinine in a spot urine collected after overnight rest
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=22 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Urine Albumin-to-creatinine Ratio
Baseline
|
12.0 mg/g
Standard Deviation 23.6
|
7.9 mg/g
Standard Deviation 7.6
|
6.3 mg/g
Standard Deviation 3.8
|
|
Urine Albumin-to-creatinine Ratio
13 Weeks
|
10.5 mg/g
Standard Deviation 14.8
|
9.2 mg/g
Standard Deviation 10.7
|
10.1 mg/g
Standard Deviation 19.4
|
PRIMARY outcome
Timeframe: Baseline to 2 and 14 weeksPopulation: Due to missed study visits and missing samples, there is incomplete data for the following arms/time periods: Liraglutide: Baseline: 2 participants/Week 14: 3 participants; Sitagliptin: Baseline: 1 participants/Week 14: 1 participants; Diet: Baseline: 3 participants/Week 14: 6 participants
Plasma plasminogen activator inhibitor-1 antigen
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=22 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Change in Plasminogen Activator Inhibitor-1
Baseline to 2 weeks
|
-2.4 units/mL
Standard Deviation 7.8
|
-1.3 units/mL
Standard Deviation 8.3
|
1.1 units/mL
Standard Deviation 6.9
|
|
Change in Plasminogen Activator Inhibitor-1
Baseline to 14 weeks
|
-3.7 units/mL
Standard Deviation 8.7
|
1.3 units/mL
Standard Deviation 6.3
|
-3.6 units/mL
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatmentPopulation: Due to missed study visits there is incomplete data for the following arms/time periods: Liraglutide 14 weeks- 2 participants; Diet 14 weeks: 5 participants
The mean of three systolic blood pressure measurements one minute apart using a oscillometric recording device with patient in supine position
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=22 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Blood Pressure
Baseline
|
124.1 mmHg
Standard Deviation 7.7
|
120.2 mmHg
Standard Deviation 11.3
|
127.7 mmHg
Standard Deviation 8.3
|
|
Blood Pressure
2 weeks
|
122.9 mmHg
Standard Deviation 6.3
|
117.5 mmHg
Standard Deviation 11.3
|
121.7 mmHg
Standard Deviation 6.8
|
|
Blood Pressure
14 weeks
|
122.2 mmHg
Standard Deviation 7.8
|
118.2 mmHg
Standard Deviation 13.9
|
119.7 mmHg
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatmentPopulation: Due to missed study visits there is incomplete data for the following arms/time periods: Liraglutide 14 weeks- 2 participants; Diet 14 weeks: 5 participants
The mean of three measurements with the patient in the supine position
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=22 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Heart Rate
Baseline
|
64.9 Beats per minute
Standard Deviation 7.5
|
67.2 Beats per minute
Standard Deviation 9.0
|
63.8 Beats per minute
Standard Deviation 8.8
|
|
Heart Rate
2 weeks
|
68.9 Beats per minute
Standard Deviation 6.4
|
66.2 Beats per minute
Standard Deviation 9.2
|
63.2 Beats per minute
Standard Deviation 9.5
|
|
Heart Rate
14 weeks
|
68.9 Beats per minute
Standard Deviation 5.6
|
65.9 Beats per minute
Standard Deviation 8.5
|
61.7 Beats per minute
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatmentPopulation: Due to missed study visits there is incomplete data for the following arms/time periods: Liraglutide Baseline-1, 2 weeks 1, 14 weeks- 2 participants; Sitagliptin 2 weeks 1, 14 weeks- 1 participants; Diet 14 weeks: 5 participants
Blood glucose collected after overnight fast
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=22 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Fasting Glucose
14 weeks
|
85.2 mg/dl
Standard Deviation 7.3
|
96.6 mg/dl
Standard Deviation 5.6
|
91.2 mg/dl
Standard Deviation 9.8
|
|
Fasting Glucose
Baseline
|
95.3 mg/dl
Standard Deviation 8.6
|
97.6 mg/dl
Standard Deviation 10.0
|
94.5 mg/dl
Standard Deviation 12.0
|
|
Fasting Glucose
2 weeks
|
84.26 mg/dl
Standard Deviation 7.9
|
93.9 mg/dl
Standard Deviation 8.1
|
92.4 mg/dl
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatmentPopulation: Due to missed study visits or missing data there is incomplete data for the following arms/time periods: Liraglutide 2 weeks 3, 14 weeks- 3 participants; Sitagliptin 2 weeks 2, 14 weeks- 1 participants; Diet 14 weeks: 5 participants
Plasma insulin collected after overnight fast
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=22 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Fasting Insulin
Baseline
|
22.7 uU/mL
Standard Deviation 16.8
|
23.3 uU/mL
Standard Deviation 14.4
|
26.7 uU/mL
Standard Deviation 21.2
|
|
Fasting Insulin
2 weeks
|
18.3 uU/mL
Standard Deviation 12.5
|
29.4 uU/mL
Standard Deviation 25.4
|
19.7 uU/mL
Standard Deviation 16.5
|
|
Fasting Insulin
14 weeks
|
20.3 uU/mL
Standard Deviation 14.7
|
26.0 uU/mL
Standard Deviation 19.0
|
20.3 uU/mL
Standard Deviation 13.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 14 weeksPopulation: Due to missed study visits or missing data there is incomplete data for the following arms/time periods: Liraglutide 2 participants; Diet 5 participants
Weight measured in light clothing without shoes
Outcome measures
| Measure |
Liraglutide
n=42 Participants
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=22 Participants
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=17 Participants
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Change in Weight
|
-2.72 kg
Standard Deviation 3.44
|
-0.71 kg
Standard Deviation 2.12
|
-4.95 kg
Standard Deviation 3.98
|
Adverse Events
Liraglutide
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Sitagliptin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Hypocaloric Diet
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liraglutide
n=46 participants at risk
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=23 participants at risk
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=24 participants at risk
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis/abscess
|
0.00%
0/46 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
4.3%
1/23 • Number of events 1 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/24 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Renal and urinary disorders
Nephrolithiasis and hydronephrosis
|
0.00%
0/46 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
4.3%
1/23 • Number of events 1 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/24 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/46 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
4.2%
1/24 • Number of events 1 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
Other adverse events
| Measure |
Liraglutide
n=46 participants at risk
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Liraglutide: subcutaneous liraglutide daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Sitagliptin
n=23 participants at risk
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Sitagliptin: oral sitagliptin daily
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
Hypocaloric Diet
n=24 participants at risk
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
hypocaloric diet: Reduced calorie intake to achieve weight loss.
Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.4%
8/46 • Number of events 8 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
4.2%
1/24 • Number of events 1 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
3/46 • Number of events 3 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/24 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Nervous system disorders
Headache
|
8.7%
4/46 • Number of events 4 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/24 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Surgical and medical procedures
Study day procedure adverse event
|
47.8%
22/46 • Number of events 41 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
26.1%
6/23 • Number of events 9 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
25.0%
6/24 • Number of events 9 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Musculoskeletal and connective tissue disorders
Injury
|
4.3%
2/46 • Number of events 2 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/24 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/46 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
4.2%
1/24 • Number of events 1 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
6.5%
3/46 • Number of events 3 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/24 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Nervous system disorders
Lightheaded
|
4.3%
2/46 • Number of events 2 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
4.2%
1/24 • Number of events 1 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
|
Nervous system disorders
Insomnia
|
2.2%
1/46 • Number of events 1 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/23 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
0.00%
0/24 • After randomization to 14 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion at each screening visit, study day, and at week 4, week 8 and week 12 check-ins.
|
Additional Information
Dr. James M. Luther, MD MSCI (Principal Investigator)
Vanderbilt University Medical Center
Phone: (615) 936-3420
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place