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Type 2 Diabetes MellitusPhase 3NCT03707171

Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Liraglutide in people with Type 2 Diabetes Mellitus, run by Third Military Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type 2 diabetes mellitus (T2DM) can impaire cognitive function,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 18 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Liraglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
1 Oct 2018to 1 May 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes。

Who cannot join

  • Type 2 diabetes with acute diabetic complications.
  • Type 1 diabetes.
  • Other diseases affecting cognitive function (congenital dementia,brain trauma,severe heart dysfunction,severe kidney dysfunction,severe lung dysfunction,epilepsy,severe hypoglycemic coma,cerebrovascular disease,ischemic heart disease,etc).
  • Alcohol abuse,mental illness and psychoactive substance abuse.
  • History of thyroid disease.
  • Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

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

Other trials in China

About this study

Type 2 diabetes mellitus (T2DM) can impaire cognitive function,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.

Glucagon-like peptide-1 (GLP-1) is a member of an endogenous class of incretin hormones synthesized in intestinal epithelial L-cells.GLP-1 enhances glucose-dependent secretion of insulin,inhibits glucagon secretion, slows gastric emptying and reduces food intake. Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. It has been proved that Liraglutide can improve insulin resistance and cognitive function in AD animals. Therefore, it is speculated that Liraglutide may interfere with the occurrence and development of cognitive dysfunction in patients with T2DM. In order to confirm the effects, the investigators conduct an open, prospective, positive controlled study in patients with T2DM. The effect on BMI,waist circumference, hip circumference, waist-to-hip ratio,fasting plasma glucose，glycosylated hemoglobin,blood lipids and cognitive function were measured to explore the effects of liraglutide in patients with T2DM.

The overall goal of this study is to explore the effects of liraglutide on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.

Being tested
Liraglutide, placebo
Keywords
Type 2 diabetes mellitus, Cognitive function, Liraglutide
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. It has been proved that Liraglutide can improve insulin resistance and cognitive function in AD animals. Therefore, it is speculated that Liraglutide may interfere with the occurrence and development of cognitive dysfunction in patients with T2DM. In order to confirm the effects, the investigators conduct an open, prospective, positive controlled study in patients with T2DM.

  • placeboDrug

    Any hypoglycemic drugs except glucagon-like peptide type 1 (GLP-1) analogue.

Study groups in NCT03707171
Study groupRoleWhat they receive
LiraglutideActive comparator12 weeks of liraglutide treatment at adjusting dose, up to 1.8mg/day Drug: liraglutide
Receives: Drug: Liraglutide
PlaceboPlacebo comparator12 weeks of Placebo treatment at adjusting dose Drug:Placebo
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of cognitive function assessed by cognitive function scale after 12 weeks.

    The cognitive function will be calculated from performance on the following measures: (1)Digit Span Test(DST);(2) Rey Auditory Verbal Learning(RAVL);(3) Long-Delay Free Recall(LDFR);(4) Trail Making Test(TMT);(5) Animal Naming Test(ANT);(6) Clock Drawing Test(CDT);(7)Minimum Mental State Examination(MMSE);(8)Memory and executive screening(MES);(8)functional near-infrared spectroscopy.

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

Secondary outcomes (11)

  1. Changes of systolic blood pressure and diastolic blood pressure

    Change of systolic blood pressure and diastolic blood pressure compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  2. Change of fasting plasma glucose

    Change of fasting plasma glucose compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  3. Change of HbA1c

    Change of HbA1c compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  4. Change of lipid profile

    Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  5. Change of liver enzymes

    Change of liver enzymes (ALT, AST in IU/L) compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  6. Change of kidney function

    Change of kidney function（serum creatinine in umol/L、eGFR in ml/min） compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  7. Change of CRP

    Change of CRP compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  8. Change of Body mass index(BMI)

    Change of Body mass index(BMI) compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  9. Change of waist circumference

    Change of waist circumference compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  10. Change of hip circumference

    Change of hip circumference compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

  11. Change of waist-to-hip ratio

    Change of waist-to-hip ratio compared with baseline, and between the intervention and control group at the end of the study (12 weeks)

    Measured: Baseline,4weeks,8weeks，12weeks(End of Trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start1 Oct 2018
  3. Primary completion1 Feb 2019
  4. Study completion1 May 2019

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03707171
Sponsor's protocol ID
Liraglutide
Status last verified
Jul 2019
First submitted
27 Sep 2018
Last updated
10 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li Q, Jia M, Yan Z, Li Q, Sun F, He C, Li Y, Zhou X, Zhang H, Liu X, Bu X, Gao P, He H, Zhao Z, Zhu Z. Activation of Glucagon-Like Peptide-1 Receptor Ameliorates Cognitive Decline in Type 2 Diabetes Mellitus Through a Metabolism-Independent Pathway. J Am Heart Assoc. 2021 Jul 20;10(14):e020734. doi: 10.1161/JAHA.120.020734. Epub 2021 Jul 10.

    PubMed 34250817

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liraglutide 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 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: finished, as of the sponsor's last update on 10 Jul 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 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 of cognitive function assessed by cognitive function scale after 12 weeks. (time frame: Baseline,4weeks,8weeks，12weeks(End of Trial)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03707171, which also lists 1 linked publication.

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 10 Jul 2019.

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