Diabetes Mellitus, Type 2Phase 3ESCDPNCT04304261
Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)
A Phase 3 study testing Canagliflozin and Sitagliptin in people with Diabetes Mellitus, Type 2 and Cognitive Functions Confusion, run by Third Military Medical University at 1 site in China.
Trial summary
Type 2 diabetes is associated with diabetic cognopathy, the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population. Cognitive impairment seriously affects the health and quality of life of the elderly. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cognitive Functions Confusion
- What is being tested?
- Canagliflozin and Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Apr 2024
- Phase
- Phase 3
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly onset type 2 diabetes within 3 months
- 7%<HbA1c<10%
Who cannot join
- Type 2 diabetes with acute diabetic complications.
- Type1 diabetes.
- Thyroid dysfuncition.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- Hepatic insufficiency (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
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- Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- Acute infections, tumor, severe arrhythmia.
- Alcohol or medicine addiction, psychoactive substance abuse.
- Other diseases affecting cognitive function (congenital dementia, brain trauma, parkinson's diseases, toxicencephacopathy,epilepsy, mental disorders, severe lungdy sfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.)
- Fertile woman without contraceptives.
- Allergic to or have contraindication to the intervention drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient
Type 2 diabetes is associated with diabetic cognopathy, the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population. Cognitive impairment seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied.
Sodium-glucose transporter-2 (SGLT-2) inhibitors, which lower serum glucose by inhibiting SGLT2-mediated glucose reabsorption in renal proximal tubules, could be neuroprotective. It was recently reported that the SGLT-2 inhibitor improved cognitive function and ameliorated oxidative stress via attenuating mitochondrial dysfunction, insulin resistance, inflammation, and apoptosis in mice or HFD-induced obese rats, that means SGLT-2 inhibitor may provide neuroprotection in the diabetic brain. Hence, Invokana (Canagliflozin) might act as a potent dual inhibitor of AChE and SGLT2. Since the development of diabetes is associated with AD, the design of new AChE inhibitors based on antidiabetic drug scaffolds would be particularly beneficial. Moreover, the present computational study reveals that Invokana (Canagliflozin) is expected to form the basis of a future dual therapy against diabetes associated neurological disorders.
The overall goal of this study is to explore the effects of SGLT2 inhibitor on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.
- Being tested
- Canagliflozin, Sitagliptin
- Keywords
- Diabetes mellitus, Cognitive Functions, Sodium glucose transporter
- Medical subject headings
- Diabetes Mellitus, Type 2, Confusion, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
12 weeks of Canagliflozin(100mg/day) treatment
SitagliptinDrug
12 weeks of Sitagliptin (100mg/day) treatment
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin | Experimental | 12 weeks of Canagliflozin(100mg/day) treatment, randomly Receives: Drug: Canagliflozin |
| Sitagliptin | Experimental | 12 weeks of Sitagliptin (100mg/day) treatment, randomly Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cognitive function assessed by cognitive function scale
cognitive function scale
Measured: 12 weeks
Secondary outcomes (3)
Changes of standardized uptake values of brain and splanchnic organs assessed by 18F-PET-CT
18F-PET-CT
Measured: 1 week
Changes of brain function assessed by near infrared brain functional imaging
near infrared brain functional imaging
Measured: 4 week
Changes of urinary sodium and glucose excretion (mmol/24h)
urinary sodium and glucose excretion
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Jul 2021
- Primary completion1 Dec 2023
- Study completion30 Apr 2024
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304261
- Sponsor's protocol ID
- ESCDP
- Acronym
- ESCDP
- Status last verified
- May 2024
- First submitted
- 9 Mar 2020
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient
- ClinicalTrials.gov ID
- NCT04304261
- Acronym / sponsor ID
- ESCDP / ESCDP
- Keywords
- Diabetes mellitus, Cognitive Functions, Sodium glucose transporter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 11 Mar 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.
Type 2 diabetes is associated with diabetic cognopathy, the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population. Cognitive impairment seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied.
Sodium-glucose transporter-2 (SGLT-2) inhibitors, which lower serum glucose by inhibiting SGLT2-mediated glucose reabsorption in renal proximal tubules, could be neuroprotective. It was recently reported that the SGLT-2 inhibitor improved cognitive function and ameliorated oxidative stress via attenuating mitochondrial dysfunction, insulin resistance, inflammation, and apoptosis in mice or HFD-induced obese rats, that means SGLT-2 inhibitor may provide neuroprotection in the diabetic brain. Hence, Invokana (Canagliflozin) might act as a potent dual inhibitor of AChE and SGLT2. Since the development of diabetes is associated with AD, the design of new AChE inhibitors based on antidiabetic drug scaffolds would be particularly beneficial. Moreover, the present computational study reveals that Invokana (Canagliflozin) is expected to form the basis of a future dual therapy against diabetes associated neurological disorders.
The overall goal of this study is to explore the effects of SGLT2 inhibitor on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canagliflozin | Experimental | Drug: Canagliflozin12 weeks of Canagliflozin(100mg/day) treatment, randomly |
| Sitagliptin | Experimental | Drug: Sitagliptin12 weeks of Sitagliptin (100mg/day) treatment, randomly |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly onset type 2 diabetes within 3 months
- 7%<HbA1c<10%
Key exclusion criteria (12 listed)
- Type 2 diabetes with acute diabetic complications.
- Type1 diabetes.
- Thyroid dysfuncition.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
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 |
|---|---|---|
| Canagliflozin12 weeks of Canagliflozin(100mg/day) treatment | Drug | Canagliflozin |
| Sitagliptin12 weeks of Sitagliptin (100mg/day) treatment | Drug | Sitagliptin |
Primary outcome
Changes of cognitive function assessed by cognitive function scale
Time frame: 12 weeks
cognitive function scale
3 secondary outcomes
Changes of standardized uptake values of brain and splanchnic organs assessed by 18F-PET-CT
Time frame: 1 week
Changes of brain function assessed by near infrared brain functional imaging
Time frame: 4 week
Changes of urinary sodium and glucose excretion (mmol/24h)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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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 3 study testing Canagliflozin and Sitagliptin in people with Diabetes Mellitus, Type 2 and Cognitive Functions Confusion, run by Third Military Medical University at 1 site in China.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 30 May 2024. 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 China. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of cognitive function assessed by cognitive function scale (time frame: 12 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 30 May 2024.