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

March 30, 2022 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • 180 Fenglin Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on glycemic variability
Time Frame: 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
one months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on Glycemic Control
Time Frame: one months
It will be assessed at baseline and after one months of treatment to determine the anti-diabetic effect of dulaglutide
one months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 1, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSE-202003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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