The Effect of Donepezil on Glycemic Control in Type II Diabetics
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change in Hemoglobin A1C
Study Overview
Brief 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.
Detailed Description
The study is a randomized, double blinded, treatment-controlled, parallel design to investigate the effect of donepezil (administration of 5-10 mg of donepezil daily, orally, over 8 week period) on clinical outcomes reflecting diabetic control. The research assistant will not be blinded. The investigator and patient shall be blinded. A computer program will be used to randomize the patients.
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.
As many patients as required to meet the enrollment numbers shall be screened. Patients will be monitored daily for blood pressure, glucose levels and heart rate, during the period of hospitalization. Adjustments in insulin or oral hypoglycemic, blood pressure and heart rate control medications will occur during this time. Follow up visits will be made as required and at the end of week 8.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 51 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Donepezil treatment group
Administration of 5mg or 10 mg of donepezil daily
Intervention: Donepezil 5-10 Mg Oral Tablet (Drug)
Control group
Administration of placebo
Intervention: Placebo Oral Tablet (Drug)
Outcomes
Primary Outcomes
Change in Hemoglobin A1C
Time Frame: 8 weeks
Secondary Outcomes
- Change in blood urea nitrogen(8 Weeks)
- Change in creatinine(8 weeks)
Investigators
Stephen Wills
Principal Investigator
University of Maryland, Baltimore