Phase 4
Completed N=13
Anti-Diabetic Medications to Fight PD and LBD
Source: ClinicalTrials.gov NCT06263673 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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.
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. Informational only — not medical advice.