The Effect of Donepezil on Glycemic Control in Type II Diabetics

NCT04507438 | Terminated Phase 2 FDA Drug

• 1 other identifier: SH201804
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1C

  8 weeks

Secondary Outcomes (2)

• Change in blood urea nitrogen

  8 Weeks

• Change in creatinine

  8 weeks

Other Outcomes (2)

• Change in lipid profile

  8 Weeks

• Change in albumin

  8 weeks

Study Arms (2)

Donepezil treatment group

EXPERIMENTAL

Administration of 5mg or 10 mg of donepezil daily

Drug: Donepezil 5-10 Mg Oral Tablet

Control group

PLACEBO COMPARATOR

Administration of placebo

Drug: Placebo Oral Tablet

Interventions

Donepezil 5-10 Mg Oral Tablet DRUG

Donepezil 5mg or 10mg oral tablet administered daily for an 8 week period

Donepezil treatment group

Placebo Oral Tablet DRUG

Placebo oral tablet administered daily for an 8 week period

Control group

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Shore Regional Health

Easton, Maryland, 21601, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Donepezil; Tablets

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: August 11, 2020
• Study Start: July 12, 2019
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

US (1)