A Phase 2 interventional study of Donepezil 5-10 Mg Oral Tablet and Placebo Oral Tablet in Diabetes Mellitus, Type 2, sponsored by University of Maryland, Baltimore. Terminated at 1 site in United States. Open to participants aged 51 Years and older. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration of 5mg or 10 mg of donepezil daily
Drug: Donepezil 5-10 Mg Oral Tablet
Administration of placebo
Drug: Placebo Oral Tablet
Donepezil 5mg or 10mg oral tablet administered daily for an 8 week period
Placebo oral tablet administered daily for an 8 week period
Change in Hemoglobin A1C
Time frame: 8 weeks
Change in blood urea nitrogen
Change will be assessed by reviewing blood urea nitrogen/creatinine
Time frame: 8 Weeks
Change in creatinine
Change will be assessed by reviewing blood urea nitrogen/creatinine
Time frame: 8 weeks
Change in lipid profile
Time frame: 8 Weeks
Change in albumin
Weight and albumin will be monitored to asses change in nutritional status
Time frame: 8 weeks
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore