Nanjing First Hospital, Nanjing Medical University

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanjing First Hospital
RECRUITING
Nanjing
Contact Information
Primary
Jianhua Ma, Doctor
majianhua196503@126.com
+862552887091
Time Frame
Start Date: 2022-03-15
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 150
Treatments
Experimental: Tirzepatide
Tirzepatide 5、10、15mg
Active_comparator: Insulin Glargine
Insulin Glargine 6 international unit (IU)
Related Therapeutic Areas
Sponsors
Leads: Nanjing First Hospital, Nanjing Medical University

This content was sourced from clinicaltrials.gov