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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT04374578
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Study Start: 2020-05-08
• Status Verified: 2020-07
• Primary Completion: 2021-01-31
• Study Completion: 2021-06-30
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect on glycemic variability	one months	The FreeStyle Libre Pro (Abbott Co., Ltd) will be used to monitor glucose levels during the four weeks from the day before the first administration of the study drug

Secondary Outcome Measures

Name	Time	Method
Effect on Glycemic Control	one months	It will be assessed at baseline and after one months of treatment to determine the anti-diabetic effect of dulaglutide

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, China