- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03961659
Effects of Liraglutid, Dapagliflozin and Acarbose on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in Overweight/Obese T2DM Patients Controlled Inadequately With Metformin Monotherapy.
May 22, 2019 updated by: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
A Prospective, Randomized, Open Label, Parallel, 16-week Study to Explore and Evaluate the Therapeutic Effects of Liraglutid, Dapagliflozin and Acarbose on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in Overweight/Obese Patients With T2DM Inadequately Controlled With Metformin Monotherapy.
This is a prospective, randomized, open label, parallel, 16-week study to explore and evaluate the therapeutic effects of liraglutid, dapagliflozin and acarbose on the cognitive function, olfactory function, and odor-induced brain activation in overweight/obese patients with type 2 diabetes mellitus(T2DM) inadequately controlled with metformin monotherapy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized, open label, parallel, 16-week study to explore and evaluate the therapeutic effects of liraglutid, dapagliflozin and acarbose on the cognitive function, olfactory function, and odor-induced brain activation in overweight/obese patients with T2DM inadequately controlled with metformin monotherapy.We have 1 principle investigator, 6 sub-investigators and 1 nurse in research centre.
The sub-investigators will screen in the outpatient and inpatient departments to enroll 87 patients (29 for each arm) totally with the inclusion and exclusion criteria in 12 months.
The patients will be randomized at a 1:1:1 ratio into liraglutid, dapagliflozin and acarbose treatment group with a computer-generated random order.
All patients will also continue on their existing dose and regimen of metformin throughout the study.
At the baseline, clinical information collection, 100g-steamed bread meal test, biochemical measurement, body composition analysis, cognitive assessment, olfactory test and functional magnetic resonance imaging(fMRI) scan will be conducted for all patients.
During the treatment period, visits at 4-week intervals will be performed to evaluate the safety of drugs and adjust the dose of metformin if hypoglycaemia occurs; meanwhile, fasting and 2-hour postprandial plasma glucose assayed by fingerstick, physical examination, and olfactory test will be conducted.
At the end of the study, all of the assessments will be performed again for all recruited subjects, including early withdrawal patients.
Study Type
Interventional
Enrollment (Anticipated)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Da long Zhu, MD, PhD
- Phone Number: 86-25-83-105302
- Email: zhudldr@gmail.com
Study Contact Backup
- Name: Yan Bi, MD, PhD
- Phone Number: 86-25-83-105302
- Email: biyan@nju.edu.cn
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210008
- Recruiting
- at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≧ 40 and ≦75 years old
- T2DM patients controlled with metformin monotherapy with stable, maximum tolerated doses (≧1500mg/d, ≧12 weeks)
- HbA1c>7% and ≤9%
- Body mass index(BMI) ≥25kg/m2 and with stable weight during previous 3 months
- Right handedness
- Possessed over 6-year education
- Provision of informed consent prior to any study specific procedures
- Mini-Mental State Examination (MMSE) >24
Exclusion Criteria:
- Allergies to research drugs
- Treated with glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter 2 inhibitors, insulins, and glycosidase inhibitors in the previous 6 months
- Moderate to severe renal dysfunction defined as estimated glomerular filtration rate(eGFR)<60ml/min/1.73m2 ( eGFR was estimated by CKD-EPI creatinine equation using an online calculator).
- Hepatic insufficiency
- A history of neurological and psychiatric disorders, nasal pathologies, abnormal thyroid, pancreatitis, repeated urinary tract infection, chronic gastrointestinal dysfunction, any disease that may worsen by intestinal flatulence, alcohol or substance abuse, steroid treatment
- Any acute disease
- Inability to undergo tests or MRI scanning
- Pregnant or lactating women
- Participating in other clinical trials at the same time or within 6 months prior to the start of the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Liraglutid
Liraglutid will be titrated from 0.6mg/day to a final dose 1.8mg/day during the first 2 weeks, if well tolerated.
Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study.
Visits at 4-week intervals will be performed to evaluate the safety of drugs.
Metformin dose can be reduced in response to hypoglycaemia, but liraglutid could not be adjusted.
If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.
|
Liraglutid will be titrated from 0.6mg/day to 1.8mg/day during the first 2 weeks, if well tolerated.
All patients will also continue on their existing dose and regimen of metformin throughout the study.
Other Names:
|
Active Comparator: Dapagliflozin
Dapagliflozin will be initiated and maintained at 10mg/day every morning until the completion of the study.
Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study.
Visits at 4-week intervals will be performed to evaluate the safety of drugs.
Metformin dose can be reduced in response to hypoglycaemia, but dapagliflozin could not be adjusted.
If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.
|
Dapagliflozin will be initiated and maintained at 10mg/day every morning until the completion of the study.
All patients will also continue on their existing dose and regimen of metformin throughout the study.
Other Names:
|
Active Comparator: Acarbose
Acarbose will be initiated at 50mg three times daily for the first week, and then titrated to100mg three times daily if appropriate.
Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study.
Visits at 4-week intervals will be performed to evaluate the safety of drugs.
Metformin dose can be reduced in response to hypoglycaemia, but acarbose could not be adjusted.
If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.
|
Acarbose will be initiated at 50mg three times daily for the first week, and then titrated to 100mg three times daily if appropriate.All patients will also continue on their existing dose and regimen of metformin throughout the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of olfactory brain activation by fMRI
Time Frame: from baseline to 16 weeks' follow-up.
|
Compare the change of olfactory brain activation by fMRI from baseline to 16 weeks' follow-up
|
from baseline to 16 weeks' follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of cognitive function
Time Frame: from baseline to 16 weeks' follow-up.
|
Compare the change of Montreal Cognitive Assessment (MoCA, beijing version) from baseline to 16 weeks' follow-up.
MoCA score(ranging from 0 to 30)<26 is considered cognitive impairment and when the score is lower, the cognitive impairment is more serious.
MoCA score ≥26 is considered normal cognition.
|
from baseline to 16 weeks' follow-up.
|
Proportion of patients whose MoCA<26 scores
Time Frame: at baseline and at 16 weeks' follow-up.
|
Compare the proportion of patients whose MoCA<26 scores at baseline and at 16 weeks' follow-up.
|
at baseline and at 16 weeks' follow-up.
|
Change of blood glycaemic control
Time Frame: from baseline to 16 weeks' follow-up
|
Compare the change of glycosylated hemoglobin(HbA1c) from baseline to 16 weeks' follow-up
|
from baseline to 16 weeks' follow-up
|
Proportion of patients whose HbA1c<7%
Time Frame: at 16 weeks' follow-up.
|
Analyze the proportion of patients whose HbA1c<7% at 16 weeks' follow-up.
|
at 16 weeks' follow-up.
|
Proportion of patients whose weight loss>3% and >5%
Time Frame: from baseline to 16 weeks' follow-up.
|
Analyze the proportion of patients whose weight loss>3% and >5%
|
from baseline to 16 weeks' follow-up.
|
Olfactory threshold test
Time Frame: from baseline to 16 weeks' follow-up.
|
The olfactory threshold test (score range 1-13.5) is determined based on a series of binary dilutions of the N-butanol solution in light mineral oil.
The higher the score is, the more sensitive the participant is in detecting an odor.
Scores of 8-10 were considered normal olfactory sensitivity, whereas scores of 1-3 signified olfactory dysfunction or anosmia, and scores of ≥10 indicate better olfactory sensitivity.
|
from baseline to 16 weeks' follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2019
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
May 19, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 23, 2019
Study Record Updates
Last Update Posted (Actual)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Body Weight
- Diabetes Mellitus, Type 2
- Overweight
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Sodium-Glucose Transporter 2 Inhibitors
- Glycoside Hydrolase Inhibitors
- Dapagliflozin
- Metformin
- Acarbose
Other Study ID Numbers
- ZZ2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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