NCT05005741

Brief Summary

This study is a multi-center, open label, randomized controlled trial that main purpose of this study is to evaluate the differences of glucose control and weight loss between Beinaglutide and Dulaglutide in type 2 diabetes with overweight or or Obesity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started May 2021

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

August 9, 2021

Last Update Submit

March 15, 2023

Conditions

Diabetes Mellitus, Type 2Overweight or Obesity

Keywords

GLP-1 receptor agonistBeinaglutideDulaglutideType 2 diabetesHbA1c

Outcome Measures

Primary Outcomes (1)

  • haemoglobin A1c(HbA1c)

    Absolute changes from baseline in HbA1c at week 16.

    From baseline to 16 week.

Secondary Outcomes (12)

  • Weight loss

    From baseline to 16 week.

  • GLucose

    From baseline to 16 week.

  • Body Mass Index(BMI)

    From baseline to 16 week.

  • Waistline

    From baseline to 16 week.

  • Hipline

    From baseline to 16 week.

  • +7 more secondary outcomes

Study Arms (2)

Beinaglutide

EXPERIMENTAL
Drug: Beinaglutide

Dulaglutide

ACTIVE COMPARATOR
Drug: Dulaglutide

Interventions

BeinaglutideDRUG

Patients received beinaglutide subcutaneously three times a day for 16 weeks, the dose of beinaglutide escalate from 0.06mg to 0.2mg per 3-7 days according to subject's specific situation.

Also known as: GLP-1 receptor agonist
Beinaglutide
DulaglutideDRUG

Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.

Also known as: Trulicity, GLP-1 receptor agonist
Dulaglutide

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 70 years old from all sex;
  • Diagnosed with type 2 diabetes and HbA1c between 7% to 10%;
  • BMI from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）;
  • Volunteer to participate in the study with informed consent;

You may not qualify if:

  • Type 1 diabetes or other specific types of diabetes;
  • Taking drugs of GLP-1 receptor agonist、TZDs and SGLT2 inhibitor within 3 months of screening;
  • Taking insulin or insulin analogues more than 7 days within 3 months of screening;
  • Pregnancy, breastfeeding or planned pregnancy;
  • History of acute or chronic pancreatitis;
  • Taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening;
  • Alanine aminotransferase or aspartate transaminase more than 3 times of the normal upper limit, total bilirubin more than 2 times of the normal upper limit;
  • renal impairment (estimated glomerular filtration rate\<60mL/min per 1.73 m²);
  • History of gastrointestinal disease;
  • History of malignant tumor within 5 years of screening;
  • History of organ transplantation or AIDS;
  • History of glaucoma;
  • History of hyperthyroidism or hypothyroidism;
  • History of medullary thyroid carcinoma or multiple endocrine neoplasia II;
  • History of abnormal of Calcitonin or thyroid tumor;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Interventions

glucagon-like peptide 1 (7-36)dulaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhiguang Zhou, MD/PhD

CONTACT

86-731-85292154zhouzg@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of The National Clinical Research Center for Metabolic Diseases, and Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Endocrinology, The Second Xiangya Hospital of Central South University.

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 13, 2021

Study Start

May 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)