Phase 4 N=13 Randomized Double-blind Treatment

Anti-Diabetic Medications to Fight PD and LBD

Lewy Body Dementia · Parkinson Disease

Bottom Line

View on ClinicalTrials.gov: NCT06263673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score — 3.0; -2.5; -2.5; 1.5 score on a scale — p=0.008

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sitagliptin (Drug); Dapagliflozin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score	3.0; -2.5; -2.5; 1.5; -3.0; -0.5	0.008 sig
PRIMARY Change in Mini Mental State Examination (MMSE) Score	1.5; 0.5; 1.5	0.67
SECONDARY Change in Fasting Glucose	-3.5; -1.0; -5.0	0.65
SECONDARY Change in Orthostatic Blood Pressure	-0.1; 3.4; 4.8; -4.6; 0.0; 5.2	0.67

Summary

The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia.

Eligibility Criteria

Inclusion Criteria

Parkinson's disease or Lewy Body Dementia (diagnosis confirmed by neurologist at Mayo Clinic) with stable neurological treatment in the past approximately three months.
Glucose intolerance or mild diabetes: The American Diabetes Association criteria for pre-diabetes/ glucose intolerance includes fasting glucose 100-125, random glucose 140-199, or hemoglobin A1C 5.7-6.4% and diabetes is > 125 mg/dL, > 200 mg/dL, and 6.5% or greater, respectively (40). It has been previously reported that 50-80% of individuals with Parkinson's disease have abnormal glucose tolerance (17), so this should not limit recruitment.

Exclusion Criteria

Use of insulin or other anti-diabetes medications other than metformin.
Contraindication to taking a DPP4 inhibitor or SGLT2 inhibitor including: allergy, history of angioedema, pancreatitis, active gallbladder disease, renal impairment with EGFR < 45).
Bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia.
Use of high dose steroids.
Current systemic chemotherapy.
Pregnancy or breastfeeding.
Recent (within 30 days) or recurrent (defined as more than one in the past 12 months) urinary tract infection or yeast infection.
Other contraindication that would make study participation unsafe or make study related data unable to be interpreted.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06263673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.