Diabetes Mellitus, Type 2Phase 3NCT03249259
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
A Phase 3 study testing Choline alfoscerate in people with Diabetes Mellitus, Type 2, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Choline alfoscerate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2016to 30 Sep 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- baseline MMSE score 25-28
Who cannot join
- type 1 diabetes
- diabetes ketoacidosis or hyperosmolar hyperglycemic crisis
- HbA1c over than 9.0%
- MMSE less than 25
- abnormal TSH levels
- vitamin B12 deficiency
Show all 11Show fewer
- severe infection, perioperative state, trauma
- hypopituitarism or adrenal insufficiency
- any conditions that lead to hospitalization
- chronic alcoholics within 1 year
- any drugs that can influence to cognitive function within 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.
Read the detailed description
The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Choline alfoscerate, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline alfoscerateDrug
Also called Choline
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
PlaceboDrug
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
| Study group | Role | What they receive |
|---|---|---|
| Choline alfoscerate | Experimental | choline alfoscerate 400mg (2 caps - 1 cap bid) Receives: Drug: Choline alfoscerate |
| Control | Placebo comparator | Placebo (2 caps - 1 cap bid) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Change of MMSE Score
Measured: 6 months
Secondary outcomes (2)
Glucose metabolism
Changes in HbA1c
Measured: 6 months
Glucose metabolism
Changes in fasting glucose concentration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start10 Mar 2016
- Primary completion30 Jun 2019
- Study completion30 Sep 2019
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 Seoul National University Bundang HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249259
- Sponsor's protocol ID
- B-1508-312-006
- Status last verified
- Oct 2019
- First submitted
- 9 Aug 2017
- Last updated
- 8 Oct 2019
- Results posted
- 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 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03249259
- Acronym / sponsor ID
- B-1508-312-006
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 15 Aug 2017 (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.
In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.
Detailed description
The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Choline alfoscerate | Experimental | Drug: Choline alfosceratecholine alfoscerate 400mg (2 caps - 1 cap bid) |
| Control | Placebo comparator | Drug: PlaceboPlacebo (2 caps - 1 cap bid) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes
- baseline MMSE score 25-28
Key exclusion criteria (11 listed)
- type 1 diabetes
- diabetes ketoacidosis or hyperosmolar hyperglycemic crisis
- HbA1c over than 9.0%
- MMSE less than 25
- abnormal TSH levels
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 |
|---|---|---|
| Choline alfoscerateAlso: CholineTreatment duration is 6 months and can be extended to 12 months with participant's agreement. | Drug | Choline alfoscerate |
| PlaceboTreatment duration is 6 months and can be extended to 12 months with participant's agreement. | Drug | Control |
Primary outcome
Cognitive function
Time frame: 6 months
Change of MMSE Score
2 secondary outcomes
Glucose metabolism
Time frame: 6 months
Glucose metabolism
Time frame: 6 months
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 8 Oct 2019.
- 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 Choline alfoscerate in people with Diabetes Mellitus, Type 2, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 11 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 8 Oct 2019. 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 South Korea. 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 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?
Cognitive function (time frame: 6 months). 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 8 Oct 2019.