Type 2 Diabetes MellitusPhase 4NCT05553093
Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes
A Phase 4 study testing Tirzepatide and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Tirzepatide and Insulin Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Jianhua Ma, Doctor, +862552887091, majianhua196503@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tirzepatide, Insulin Glargine
- 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.
TirzepatideDrug
Also called Tirzepatide 5、10、15mg
Tirzepatide ih qw
Insulin GlargineDrug
Also called Adjust insulin dose according to fasting plasma glucose (FBG)
6 IU ih qd
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Tirzepatide 5、10、15mg Receives: Drug: Tirzepatide |
| Insulin Glargine | Active comparator | Insulin Glargine 6 international unit (IU) Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sugar changes
Effects of Tirzepatide and Insulin Glargine on blood sugar changes in Patients With Type 2 Diabetes Mellitus
Measured: 40 weeks
blood lipid changes
Effects of Tirzepatide and Insulin Glargine on blood lipid changes in Patients With Type 2 Diabetes Mellitus
Measured: 40 weeks
Brain function
Effects of Tirzepatide and Insulin Glargine on brain function through VBM and ASL-fMRI in Patients With Type 2 Diabetes Mellitus.
Measured: 40 weeks
Secondary outcomes (2)
Body composition analysis
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.
Measured: 40 weeks
Inflammation factors, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.
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.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start15 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Oct 2027 (estimated)
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.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, Doctor, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553093
- Sponsor's protocol ID
- KY20220124-02
- Status last verified
- Sep 2022
- First submitted
- 12 Apr 2022
- Last updated
- 23 Sep 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 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanjing First Hospital, Nanjing Medical University
- ClinicalTrials.gov ID
- NCT05553093
- Acronym / sponsor ID
- KY20220124-02
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 23 Sep 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideTirzepatide 5、10、15mg |
| Insulin Glargine | Active comparator | Drug: Insulin GlargineInsulin Glargine 6 international unit (IU) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| TirzepatideAlso: Tirzepatide 5、10、15mgTirzepatide ih qw | Drug | Tirzepatide |
| Insulin GlargineAlso: Adjust insulin dose according to fasting plasma glucose (FBG)6 IU ih qd | Drug | Insulin Glargine |
Primary outcome
blood sugar changes
Time frame: 40 weeks
Effects of Tirzepatide and Insulin Glargine on blood sugar changes in Patients With Type 2 Diabetes Mellitus
blood lipid changes
Time frame: 40 weeks
Effects of Tirzepatide and Insulin Glargine on blood lipid changes in Patients With Type 2 Diabetes Mellitus
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.
2 secondary outcomes
Body composition analysis
Time frame: 40 weeks
Inflammation factors, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.
Time frame: 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
Jianhua Ma, Doctor study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing 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 5 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 23 Sep 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Ma, Doctor (+862552887091 ext. +8618951670116, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sugar changes (time frame: 40 weeks). The study lists 3 primary outcomes in all. 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 23 Sep 2022.