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

Type 2 Diabetes Clinical Trial

— DIVE  

Official title:

Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes: A Multi-center Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374578
• Other study ID #: ZSE-202003
• Status: Completed
• Start date: May 8, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dulaglutide 1.5 MG/ML
Dulaglutide 1.5Mg qw sc injection for 4 weeks

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect on Glycemic Control	It will be assessed at baseline and after one months of treatment to determine the anti-diabetic effect of dulaglutide	one months