The Effect of Donepezil on Glycemic Control in Type II Diabetics

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Donepezil 5-10 Mg Oral Tablet; Drug: Placebo Oral Tablet

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.

Any anticholinergic drugs will be eliminated from the patients' medical regimen with the exception for inhaled anticholinergic. There is no known major contraindication of acetylcholinesterase inhibitors (like for eg: galantamine, rivastigmine and donepezil) Patients shall be monitored closely for vagotonic effect. Acetylcholine is known to have a vagotonic effect lowering heart rate and blood pressure. Therefore, during the course of administration of the drug close attention to heart rate and blood pressure will be a significant part off the clinical management of patients. If the patients are on beta blockers, their beta blocker dose will be closely monitored and adjusted as required.

Proton pump inhibitors will be used to guard against any possible GI bleed. 40 mg of pantoprazole once daily.

Patient will be observed for seizures. The patients will be examined for pulmonary exacerbation during treatment in the hospital. If the pulmonary status deteriorates they will be eliminated from the study. The medication administration will not start sooner than 24 hrs after surgery. Patients shall be observed for exaggerated response from anesthesia.

Only lipid profile and fasting blood sugar has to be done fasting. As many tests as possible shall be combined and done at the same time to avoid multiple needle pricks to the patient.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Easton, Maryland, United States, 21601
      • University of Maryland Shore Regional Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Donepezil treatment group; Administration of 5mg or 10 mg of donepezil daily	Drug: Donepezil 5-10 Mg Oral Tablet; Donepezil 5mg or 10mg oral tablet administered daily for an 8 week period
Placebo Comparator: Control group; Administration of placebo	Drug: Placebo Oral Tablet; Placebo oral tablet administered daily for an 8 week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hemoglobin A1C	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood urea nitrogen	Change will be assessed by reviewing blood urea nitrogen/creatinine	8 Weeks
Change in creatinine	Change will be assessed by reviewing blood urea nitrogen/creatinine	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lipid profile		8 Weeks
Change in albumin	Weight and albumin will be monitored to asses change in nutritional status	8 weeks

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: SH201804

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes