| Registry | NCT03249259 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 36 (Actual) |
| Sponsor | Seoul National University Bundang Hospital (Other) |
| Conditions | Diabetes Mellitus, Type 2 |
| Interventions | Choline alfoscerate, Placebo (Drug) |
| Dates | start 2016-03-10, primary completion 2019-06-30, completion 2019-09-30, first posted 2017-08-15, last updated 2019-10-08 |
| Locations | 1 site in South Korea |
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All trials for Diabetes Mellitus, Type 2 All trials of Choline alfoscerate All trials of Placebo
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Choline alfoscerate | Experimental | Drug: Choline alfoscerate | choline alfoscerate 400mg (2 caps - 1 cap bid) |
| Control | Placebo comparator | Drug: Placebo | Placebo (2 caps - 1 cap bid) |
Sex: All, ages: 60 Years to any
Inclusion Criteria: * type 2 diabetes * baseline MMSE score 25-28 Exclusion Criteria: * type 1 diabetes * diabetes ketoacidosis or hyperosmolar hyperglycemic crisis * HbA1c over than 9.0% * MMSE less than 25 * abnormal TSH levels * vitamin B12 deficiency * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | South Korea |