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Completed

NCT Number: NCT04374578

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

180 Fenglin Road

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dulaglutide 1.5 MG/ML

Drug

Dulaglutide 1.5Mg qw sc injection for 4 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Acronym: DIVE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 5, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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