The Effect of Donepezil on Glycemic Control in Type II Diabetics

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to establish the effectiveness of the drug Donepezil in treating Type 2 Diabetes Mellitus compared to a control treatment. Donepezil is not approved by the FDA to treat Type 2 Diabetes Mellitus and its use in this research is experimental. 50 patients with Type 2 Diabetes Mellitus (Adult Onset Diabetes Mellitus) will be randomized to either the donepezil treatment group or the control group after screening. (25 patients in each arm; a total of 50 patients). Both men and women shall be enrolled.Donepezil shall be orally administered to the study group. Control group will get an orally administered placebo which is an inert compound, lactose. Wk0 will be the randomization visit. The patients will take the drug for 8 weeks and the last follow up visit will be the last day of week 8.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Patients over the age of 50 with Type 2 Diabetes Mellitus, regardless of co-morbidities including renal and vascular insufficiency, Cardiovascular Autonomic Neuropathy, Hypertension, Chronic Obstructive Pulmonary Disease or Coronary Disease will be selected.

Exclusion Criteria:

• Patients under the age of 50

• Patients who are pregnant or lactating

• Patients who are lactose intolerance

• Patients with an allergy to Donepezil

• Prothrombin Time and International Normalized Ratio value greater than 1.25

• Pre-menopausal women and patients allergic to Donepezil are excluded.