Trial Outcomes & Findings for The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects (NCT NCT00659711)
NCT ID: NCT00659711
Last Updated: 2022-07-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-07-21
Participant Flow
Participant milestones
| Measure |
Januvia 100mg
The first group will be started on 100 mg sitagliptin daily for 12 weeks
Januvia (Sitagliptin) 100 mg: The first group will be started on 100 mg sitagliptin daily for 12 weeks
|
Placebo
will be placed on a placebo for 12 weeks.
Placebo: will be placed on a placebo for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects
Baseline characteristics by cohort
| Measure |
Januvia 100mg
n=12 Participants
The first group will be started on 100 mg sitagliptin daily for 12 weeks
Januvia (Sitagliptin) 100 mg: The first group will be started on 100 mg sitagliptin daily for 12 weeks
|
Placebo
n=10 Participants
will be placed on a placebo for 12 weeks.
Placebo: will be placed on a placebo for 12 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 4 • n=99 Participants
|
53 years
STANDARD_DEVIATION 3 • n=107 Participants
|
53.5 years
STANDARD_DEVIATION 3.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
BMI
|
35 kg/m^2
STANDARD_DEVIATION 1.5 • n=99 Participants
|
35.4 kg/m^2
STANDARD_DEVIATION 1.3 • n=107 Participants
|
35.2 kg/m^2
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
HbA1c
|
7.6 percentage
STANDARD_DEVIATION 0.4 • n=99 Participants
|
7.9 percentage
STANDARD_DEVIATION 0.3 • n=107 Participants
|
7.7 percentage
STANDARD_DEVIATION 0.3 • n=206 Participants
|
|
Fasting glucose
|
135 mg/dL
STANDARD_DEVIATION 13 • n=99 Participants
|
148 mg/dL
STANDARD_DEVIATION 23 • n=107 Participants
|
140 mg/dL
STANDARD_DEVIATION 18 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Januvia 100mg
n=12 Participants
The first group will be started on 100 mg sitagliptin daily for 12 weeks
Januvia (Sitagliptin) 100 mg: The first group will be started on 100 mg sitagliptin daily for 12 weeks
|
Placebo
n=10 Participants
will be placed on a placebo for 12 weeks.
Placebo: will be placed on a placebo for 12 weeks.
|
|---|---|---|
|
Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
JNK-1
|
-19 Percent change
Standard Error 8
|
4 Percent change
Standard Error 7
|
|
Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
IKK-beta
|
-17 Percent change
Standard Error 9
|
9 Percent change
Standard Error 8
|
|
Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
CCR-2
|
-24 Percent change
Standard Error 8
|
6 Percent change
Standard Error 4
|
|
Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
TNF-alpha
|
-39 Percent change
Standard Error 10
|
12 Percent change
Standard Error 8
|
|
Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
TLR-4
|
-23 Percent change
Standard Error 11
|
8 Percent change
Standard Error 5
|
|
Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
TLR-2
|
-35 Percent change
Standard Error 9
|
3 Percent change
Standard Error 5
|
SECONDARY outcome
Timeframe: value at 12 weeks minus value at baselineTo investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases oxidized lipids (9-hydroxyoctadecadienoicacid (9-HODE) and 13-HODE) in plasma and F2-isoprostane in urine of obese type 2 diabetic patients Outcome measures given are calculated from the baseline - 12 weeks.
Outcome measures
| Measure |
Januvia 100mg
n=12 Participants
The first group will be started on 100 mg sitagliptin daily for 12 weeks
Januvia (Sitagliptin) 100 mg: The first group will be started on 100 mg sitagliptin daily for 12 weeks
|
Placebo
n=10 Participants
will be placed on a placebo for 12 weeks.
Placebo: will be placed on a placebo for 12 weeks.
|
|---|---|---|
|
Change in Oxidative Stress From Baseline to 12 Weeks
|
-0.13 mM
Standard Error 0.06
|
-0.06 mM
Standard Error 0.08
|
Adverse Events
Januvia 100mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place