Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes

NCT ID: NCT04374578

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-08
• Study Completion Date: 2021-06-30

Brief Summary

Glycemic variability will be assessed using continuous glucose monitor(CGM) in type 2 diabetic patients who receive dulaglutide 1.5 mg/qw injection for 4 weeks.

Detailed Description

Glycemic fluctuation is a major problem in glucose control in diabetic patients. It is interesting to know that whether weekly GLP-1RA can improve glycemic variability in diabetic patients. The present study aims to assess the effect of dulaglutide on glycemic variability using continuous glucose monitor(CGM) (Libra, Abbott) in type 2 diabetic patients with 4 weeks.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Dulaglutide 1.5 MG/ML

Dulaglutide 1.5Mg qw sc injection for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
• Meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
• 18 ≤ age ≤ 70 years old, male or female;

Exclusion Criteria

• Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM)
• Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2).
• History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones).
• History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function.
• Fasting triglyceride level more than 750 mg/dL at screening.
• Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/minute/1.73 meter^2 (calculated using the Schwartz equation) at screening.
• ALT more than 2.5x upper limit of normal (ULN) or Bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening.
• Use of a GLP-1receptor agonist at study entry and during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoying Li, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

180 Fenglin Road

Shanghai, , China

Countries

China

Other Identifiers

ZSE-202003

Identifier Type: -

Identifier Source: org_study_id