Trial Outcomes & Findings for Anti-Diabetic Medications to Fight PD and LBD (NCT NCT06263673)

Last Updated: 2026-01-28

Results Overview

The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measures the severity and progression of Parkinson's disease. It consists of four subscales that assess various aspects of the disease, including: Non-motor experiences of daily living-Part 1 (13 questions), Motor experiences of daily living-Part 2 (13 questions), Motor examination-Part 3 (33 questions), and Motor complications-Part 4 (6 questions). Each subscale is calculated as a sum of the questions, rated from 0 (normal)-4 (severe). Thus, the subscale score ranges are: Non-motor experiences of daily living-Part 1 (range 0-52), Motor experiences of daily living-Part 2 (range 0-52), Motor examination-Part 3 (range 0-132), and Motor complication-Part 4 (range 0-24) with higher scores indicating more severe Parkinson's Disease.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

Baseline, 4 weeks

Results posted on

2026-01-28

Participant Flow

5 subjects screen failed prior to randomization assignment.

Participant milestones

Participant milestones
Measure	Sitagliptin Group Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral	Dapagliflozin Group Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral	Placebo Group Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
Overall Study STARTED	4	4	5
Overall Study COMPLETED	4	4	4
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Group Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral	Dapagliflozin Group Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral	Placebo Group Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Anti-Diabetic Medications to Fight PD and LBD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin Group n=4 Participants Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral	Dapagliflozin Group n=4 Participants Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral	Placebo Group n=5 Participants Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.	Total n=13 Participants Total of all reporting groups
Age, Categorical >=65 years	3 Participants n=158 Participants	3 Participants n=157 Participants	3 Participants n=315 Participants	9 Participants n=153 Participants
Sex: Female, Male Female	2 Participants n=158 Participants	1 Participants n=157 Participants	2 Participants n=315 Participants	5 Participants n=153 Participants
Sex: Female, Male Male	2 Participants n=158 Participants	3 Participants n=157 Participants	3 Participants n=315 Participants	8 Participants n=153 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=158 Participants	4 Participants n=157 Participants	5 Participants n=315 Participants	13 Participants n=153 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Race (NIH/OMB) Black or African American	0 Participants n=158 Participants	1 Participants n=157 Participants	0 Participants n=315 Participants	1 Participants n=153 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Race (NIH/OMB) Asian	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Age, Categorical <=18 years	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=158 Participants	1 Participants n=157 Participants	2 Participants n=315 Participants	4 Participants n=153 Participants
Race (NIH/OMB) White	4 Participants n=158 Participants	3 Participants n=157 Participants	5 Participants n=315 Participants	12 Participants n=153 Participants
Race (NIH/OMB) More than one race	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants
Region of Enrollment United States	4 participants n=158 Participants	4 participants n=157 Participants	5 participants n=315 Participants	13 participants n=153 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=4 Participants Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral	Dapagliflozin Group n=4 Participants Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral	Placebo Group n=4 Participants Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score MDS-UPDRS score-part 1	3.0 score on a scale Interval 1.0 to 4.0	-2.5 score on a scale Interval -7.0 to 0.0	-2.5 score on a scale Interval -4.0 to -1.0
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score MDS-UPDRS score-part 2	1.5 score on a scale Interval 0.0 to 4.0	-3.0 score on a scale Interval -4.0 to 0.0	-0.5 score on a scale Interval -3.0 to 1.0
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score MDS-UPDRS score-part 3	-2.0 score on a scale Interval -6.0 to 0.0	-3.0 score on a scale Interval -14.0 to 0.0	0.0 score on a scale Interval 0.0 to 2.0
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score MDS-UPDRS score-part 4	0.0 score on a scale Interval 0.0 to 8.0	0.0 score on a scale Interval -4.0 to 1.0	0.0 score on a scale Interval -2.0 to 0.0

PRIMARY outcome

Timeframe: Baseline, 4 weeks

The MMSE consists of 11 questions used by clinicians to check for cognitive impairment. Total scores range from 0 to 30 with lower scores indicating cognitive impairment.

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=4 Participants Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral	Dapagliflozin Group n=4 Participants Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral	Placebo Group n=4 Participants Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
Change in Mini Mental State Examination (MMSE) Score	1.5 score on a scale Interval 0.0 to 4.0	0.5 score on a scale Interval -2.0 to 3.0	1.5 score on a scale Interval -1.0 to 3.0

SECONDARY outcome

Timeframe: Baseline, 4 weeks

The change in fasting glucose levels (mg/dL) from baseline to 4 weeks.

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=4 Participants Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral	Dapagliflozin Group n=4 Participants Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral	Placebo Group n=4 Participants Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
Change in Fasting Glucose	-3.5 mg/dL Interval -73.0 to 2.0	-1.0 mg/dL Interval -29.0 to 8.0	-5.0 mg/dL Interval -24.0 to 15.0

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Standing average for 15 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=4 Participants Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral	Dapagliflozin Group n=4 Participants Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral	Placebo Group n=4 Participants Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
Change in Orthostatic Blood Pressure Diastolic Blood Pressure	-4.6 mmHg Interval -11.2 to 12.0	0.0 mmHg Interval -14.0 to 3.8	5.2 mmHg Interval -21.0 to 13.4
Change in Orthostatic Blood Pressure Systolic Blood Pressure	-0.1 mmHg Interval -2.0 to 11.2	3.4 mmHg Interval -6.4 to 18.2	4.8 mmHg Interval -44.0 to 12.0

Adverse Events

Sitagliptin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dapagliflozin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

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

Jessica Wilson, M.D.

Mayo Clinic

Phone: 904-953-2392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place