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

  • STATUS
    Recruiting
  • participants needed
    260
  • sponsor
    Shanghai Zhongshan Hospital
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Updated on 16 February 2024
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dulaglutide

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.

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.

Details
Condition NIDDM, diabetes mellitus, type 2, Diabetes Mellitus, diabetes (pediatric), diabetes (pediatric), diabetes mellitus, type 2
Age 18years - 70years
Treatment Dulaglutide 1.5 MG/ML
Clinical Study IdentifierNCT04374578
SponsorShanghai Zhongshan Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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
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