- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05553093
Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes
September 21, 2022 updated by: Nanjing First Hospital, Nanjing Medical University
Nanjing First Hospital, Nanjing Medical University
The effects of Tirzepatide and Insulin Glargine on glucose and lipid metabolism and inflammation in patients with type 2 diabetes mellitus.
Effects of Tirzepatide on the occurrence and development of cognitive impairment in diabetic patients and its associated pattern of changes in brain neural network characteristics.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to investigate the effects of Tirzepatide and Insulin Glargine on glucose and lipid metabolism and inflammation in patients with type 2 diabetes mellitus.
Meanwhile, this study will evaluate the effects of Tirzepatide on the development of cognitive impairment and its associated pattern of changes in neural network characteristics in diabetic patients.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 4
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: Jianhua Ma, Doctor
- Phone Number: +8618951670116 +862552887091
- Email: majianhua196503@126.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210006
- Recruiting
- Nanjing First Hospital
-
Contact:
- Jianhua Ma, Doctor
- Phone Number: +862552887091
- Email: majianhua196503@126.com
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes was diagnosed according to World Health Organization(WHO) classification or other locally applicable diagnostic criteria.
- Received stable metformin with or without sulfonylureas at least 2 months prior to visit 1 and between visits 1 and 3 (metformin ≥ 1000 mg/ day and does not exceed the maximum dose specified in the nationally approved guidelines;Sulfonylureas should be at least half of the maximum dose as stated in the national approved instructions).
- No insulin treatment (except for gestational diabetes or short-term use in acute Settings [duration ≤14 days]).
- At visit 1, HbA1c ≥ 7.5% and ≤ 11.0% was determined according to the central laboratory.
- Body mass index (BMI) ≥ 23 kg/m2.
Exclusion Criteria:
- Type 1 Diabetes Mellitus (T1DM)
- Had chronic or acute pancreatitis at any time prior to visit 1.
- A history of proliferative diabetic retinopathy or diabetic macular degeneration or non-proliferative diabetic retinopathy requiring acute treatment.
- History of severe hypoglycemia and/or insensitive hypoglycemia within 6 months prior to visit 1.
- History of ketoacidosis or hyperosmolar state/coma
- Have a known clinically significant gastric emptying disorder (e.g., severe diabetic gastroparesis or gastric outlet obstruction), have received or plan to undergo gastric bypass surgery or restrictive bariatric surgery (e.g., Lap-Band®) during the study period, or take long-term medications that directly affect gastrointestinal motility.
- Had any of the following cardiovascular diseases in the 2 months prior to the visit: acute myocardial infarction or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF).
- New York Heart Association Classification of Heart Function Class III and Class IV CHF.
- Have acute or chronic hepatitis, have signs or symptoms of any liver disease other than non-alcoholic fatty liver disease (NAFLD), or have alanine aminotransferase (ALT) levels > 3.0 times the upper limit of the normal range determined by the central laboratory at visit 1;For NAFLD patients, only ALT levels ≤ 3.0 times the upper limit of the normal range (ULN) were eligible for this trial.
- The estimated glomerular filtration rate (eGFR) calculated based on the Chronic Kidney Disease Epidemiology Collaboration equation(CKD-EPI)formula was less than 45 mL/min/1.73 m2, as determined by the central laboratory at visit 1.
- The researchers suggest that there is evidence of significant, poorly controlled endocrine abnormalities, such as thyrotoxicosis or adrenal crisis.
- Family or personal history of medullary thyroid cancer (MTC) or type 2 multiple endocrine tumor syndrome.
- Serum calcitonin level ≥ 35 ng/L (pg/mL) was determined by the central laboratory at visit 1.
- There was significant evidence of active autoimmune abnormalities (e.g., lupus or rheumatoid arthritis) and the investigators suggested that systemic glucocorticoid therapy might be required in the following 12 months.
- Has received an organ transplant (corneal transplant allowed) or is waiting for an organ transplant.
- A history of active or untreated malignancy, or a remission period of less than 5 years for a clinically significant malignancy (other than basal or squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the prostate).
- Presence of any other medical history (e.g., known drug or alcohol abuse or mental illness) that the investigator considered would have prevented the patient from complying with and completing the study protocol.
- Presence of any blood disorders that may interfere with HbA1c measurements (e.g., hemolytic anemia, sickle cell disease).
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 |
---|---|
Experimental: Tirzepatide
Tirzepatide 5、10、15mg
|
Tirzepatide ih qw
Other Names:
|
Active Comparator: Insulin Glargine
Insulin Glargine 6 international unit (IU)
|
6 IU ih qd
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood sugar changes
Time Frame: 40 weeks
|
Effects of Tirzepatide and Insulin Glargine on blood sugar changes in Patients With Type 2 Diabetes Mellitus
|
40 weeks
|
blood lipid changes
Time Frame: 40 weeks
|
Effects of Tirzepatide and Insulin Glargine on blood lipid changes in Patients With Type 2 Diabetes Mellitus
|
40 weeks
|
Brain function
Time Frame: 40 weeks
|
Effects of Tirzepatide and Insulin Glargine on brain function through VBM and ASL-fMRI in Patients With Type 2 Diabetes Mellitus.
|
40 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition analysis
Time Frame: 40 weeks
|
Effects of Tirzepatide and Insulin Glargine on body composition in Patients With Type 2 Diabetes Mellitus.
A body composition analysis will assess the fat and muscle makeup of your body.
|
40 weeks
|
Inflammation factors, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.
Time Frame: 40 weeks
|
Effects of Tirzepatide on inflammation factors in Patients With Type 2 Diabetes Mellitus,after being intervened for 40 weeks,changes of Inflammation factors were observed, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.
|
40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jianhua Ma, Doctor, The First Affiliated Hospital with Nanjing Medical University
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 (Actual)
March 15, 2022
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
October 31, 2027
Study Registration Dates
First Submitted
April 12, 2022
First Submitted That Met QC Criteria
September 21, 2022
First Posted (Actual)
September 23, 2022
Study Record Updates
Last Update Posted (Actual)
September 23, 2022
Last Update Submitted That Met QC Criteria
September 21, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Insulin
- Insulin, Globin Zinc
- Insulin Glargine
- Tirzepatide
Other Study ID Numbers
- KY20220124-02
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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