Diabetes Mellitus, Type 2Phase 2NCT04507438
The Effect of Donepezil on Glycemic Control in Type II Diabetics
A Phase 2 study testing Donepezil 5-10 Mg Oral Tablet in people with Diabetes Mellitus, Type 2, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Donepezil 5-10 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 12 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Shore Regional Health
Easton, Maryland, 21601
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Donepezil 5-10 Mg Oral Tablet, Placebo Oral Tablet
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil 5-10 Mg Oral TabletDrug
Donepezil 5mg or 10mg oral tablet administered daily for an 8 week period
Placebo Oral TabletDrug
Placebo oral tablet administered daily for an 8 week period
| Study group | Role | What they receive |
|---|---|---|
| Donepezil treatment group | Experimental | Administration of 5mg or 10 mg of donepezil daily Receives: Drug: Donepezil 5-10 Mg Oral Tablet |
| Control group | Placebo comparator | Administration of placebo Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C
Measured: 8 weeks
Secondary outcomes (2)
Change in blood urea nitrogen
Change will be assessed by reviewing blood urea nitrogen/creatinine
Measured: 8 Weeks
Change in creatinine
Change will be assessed by reviewing blood urea nitrogen/creatinine
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start12 Jul 2019
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wills, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507438
- Sponsor's protocol ID
- SH201804
- Status last verified
- Oct 2023
- First submitted
- 5 Mar 2020
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Donepezil on Glycemic Control in Type II Diabetics
- ClinicalTrials.gov ID
- NCT04507438
- Acronym / sponsor ID
- SH201804
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil treatment group | Experimental | Drug: Donepezil 5-10 Mg Oral TabletAdministration of 5mg or 10 mg of donepezil daily |
| Control group | Placebo comparator | Drug: Placebo Oral TabletAdministration of placebo |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil 5-10 Mg Oral TabletDonepezil 5mg or 10mg oral tablet administered daily for an 8 week period | Drug | Donepezil treatment group |
| Placebo Oral TabletPlacebo oral tablet administered daily for an 8 week period | Drug | Control group |
Primary outcome
Change in Hemoglobin A1C
Time frame: 8 weeks
2 secondary outcomes
Change in blood urea nitrogen
Time frame: 8 Weeks
Change in creatinine
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil 5-10 Mg Oral Tablet in people with Diabetes Mellitus, Type 2, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1C (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.