Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes

NCT05553093 | Recruiting Phase 4

• 1 other identifier: KY20220124-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• blood sugar changes

  Effects of Tirzepatide and Insulin Glargine on blood sugar changes in Patients With Type 2 Diabetes Mellitus

  40 weeks

• blood lipid changes

  Effects of Tirzepatide and Insulin Glargine on blood lipid changes in Patients With Type 2 Diabetes Mellitus

  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.

  40 weeks

Secondary Outcomes (2)

• Body composition analysis

  40 weeks

• Inflammation factors, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.

  40 weeks

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Tirzepatide 5、10、15mg

Drug: Tirzepatide

Insulin Glargine

ACTIVE COMPARATOR

Insulin Glargine 6 international unit (IU)

Drug: Insulin Glargine

Interventions

Tirzepatide DRUG

Tirzepatide ih qw

Also known as: Tirzepatide 5、10、15mg

Tirzepatide

Insulin Glargine DRUG

6 IU ih qd

Also known as: Adjust insulin dose according to fasting plasma glucose (FBG)

Insulin Glargine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tirzepatide; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides

Study Officials

• Jianhua Ma, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Jianhua Ma, Doctor

CONTACT

+862552887091; majianhua196503@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: September 23, 2022
• Study Start: March 15, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

CN (1)