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

NCT04374578 | Completed

• 1 other identifier: ZSE-202003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Effect on glycemic variability

  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

  one months

Secondary Outcomes (1)

• Effect on Glycemic Control

  one months

Interventions

Dulaglutide 1.5 MG/ML DRUG

Dulaglutide 1.5Mg qw sc injection for 4 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes come to the clinic who want to use dulaglutide and never used dulaglutide before

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaoying Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: May 8, 2020
• Primary Completion: January 31, 2021
• Study Completion: June 30, 2021
• Last Updated: March 31, 2022

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)