Type 2 Diabetes MellitusPhase 3NCT05360147
Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing Liraglutide and Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides in people with Type 2 Diabetes Mellitus, run by Third Military Medical University at 1 site in China.
Trial summary
Patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the risk of dementia. In previous observational study, the investigators found that liraglutide can improve cognitive function in patients with T2DM through a metabolism-independent pathway. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Liraglutide and Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2021to 10 May 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 Diabetes Mellitus
Who cannot join
- T2DM with acute diabetic complications;
- type 1 diabetes;
- other diseases affecting cognitive function (e.g., congenital dementia, brain trauma, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, renal dysfunction);
- alcohol abuse, mental illness, and psychoactive substance abuse;
- history of thyroid disease;
- any surgical or medical conditions that could significantly influence the absorption, distribution, metabolism, or excretion of interventional drugs;
- unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the risk of dementia. In previous observational study, the investigators found that liraglutide can improve cognitive function in patients with T2DM through a metabolism-independent pathway. Here the investigators aim to further verify such effects through a randomized, controlled study.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Liraglutide, Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides
- Keywords
- Type 2 Diabetes Mellitus, Cognitive function, Liraglutide, Functional near-infrared spectroscopy, Metabolic changes
- 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.
LiraglutideDrug
Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. We had fond its cognitive improvement effects in an observational study. In order to confirm the effects, the investigators conduct a randomized, controlled study.
Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and GlinidesDrug
oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue Receives: Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides |
| Liraglutide | Active comparator | liraglutide started at an initial dose of 0.6 mg/day and a maximum dose of 1.8mg/day, adjusted once a week when hyperglycemia was uncontrolled Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive function from baseline to 12 weeks
MMSE
Measured: 0 week, 12 week
Secondary outcomes (13)
Changes of metabolic parameters from baseline to 12 weeks
Systolic and diastolic blood pressure
Measured: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Aβ42
Measured: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
tau
Measured: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
P-tau
Measured: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
TDP-43
Measured: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
IL-6
Measured: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
IL-8
Measured: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
TNF-a
Measured: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
HbA1c
Measured: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
fasting plasma glucose
Measured: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
body mass index
Measured: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
lipid profile
Measured: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
waist circumference
Measured: 0 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start20 Jan 2021
- Primary completion20 Apr 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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
- NCT05360147
- Sponsor's protocol ID
- LICD study
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2021
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05360147
- Acronym / sponsor ID
- LICD study
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Cognitive function, Liraglutide, Functional near-infrared spectroscopy, Metabolic changes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 4 May 2022 (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.
Patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the risk of dementia. In previous observational study, the investigators found that liraglutide can improve cognitive function in patients with T2DM through a metabolism-independent pathway. Here the investigators aim to further verify such effects through a randomized, controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinidestreated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue |
| Liraglutide | Active comparator | Drug: Liraglutideliraglutide started at an initial dose of 0.6 mg/day and a maximum dose of 1.8mg/day, adjusted once a week when hyperglycemia was uncontrolled |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Type 2 Diabetes Mellitus
Key exclusion criteria (7 listed)
- T2DM with acute diabetic complications;
- type 1 diabetes;
- other diseases affecting cognitive function (e.g., congenital dementia, brain trauma, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, renal dysfunction);
- alcohol abuse, mental illness, and psychoactive substance abuse;
- history of thyroid disease;
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 |
|---|---|---|
| LiraglutideLiraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. We had fond its cognitive improvement effects in an observational study. In order to confirm the effects, the investigators conduct a randomized, controlled study. | Drug | Liraglutide |
| Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinidesoral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues | Drug | Placebo |
Primary outcome
Changes in cognitive function from baseline to 12 weeks
Time frame: 0 week, 12 week
MMSE
13 secondary outcomes
Changes of metabolic parameters from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
Time frame: 0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks
Time frame: 0 week, 12 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 4 May 2022.
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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 Liraglutide and Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides in people with Type 2 Diabetes Mellitus, 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 1 inclusion and 7 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 4 May 2022. 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. 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?
Changes in cognitive function from baseline to 12 weeks (time frame: 0 week, 12 week). 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 4 May 2022.