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Trial · Interventional

Status unknownPhase 4Registry data

The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

NCTNCT05005741 (opens ClinicalTrials.gov in a new tab)Other idBENEFIT 1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
120 participants (estimated)
Sponsor
Second Xiangya Hospital of Central South University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
1 May 2021
Primary completion
31 Dec 2023 (estimated)
Completion
31 Dec 2023 (estimated)
First posted
13 Aug 2021
Last update posted
17 Mar 2023
Conditions
Diabetes Mellitus, Type 2 · Overweight or Obesity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 4

    The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

    NCT05005741

    1 May 2021 to est. 31 Dec 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BeinaglutideDrug
  • DulaglutideDrug

Arms2

  • Experimental

    Beinaglutide

  • Active comparator

    Dulaglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. haemoglobin A1c(HbA1c)

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in HbA1c at week 16.

Secondary outcomes(12)

  1. Weight loss

    Time frame · From baseline to 16 week.

    Registry description

    The proportion of weight loss from baseline to week 16；the proportion of subjects who loss 5% weight at week 16 compares baseline.

  2. GLucose

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in fasting glucose and postprandial glucose at week 16.

  3. Body Mass Index(BMI)

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in BMI in at week 16, body mass index (BMI) was calculated as the body weight (kg)/height (m)2.

  4. Waistline

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in waistline at week 16.

  5. Hipline

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in hipline at week 16.

  6. Serum total cholesterol

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in serum total cholesterol at week 16.

  7. Serum triglycerides

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in triglycerides at week 16.

  8. Serum Low Density Lipoprotein-Cholesterol(LDL-C)

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in LDL-C at week 16.

  9. Serum High Density Lipoprotein-Cholesterol(HDL-C)

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in HDL-C at week 16.

  10. Adipose tissue of liver

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in HDL-C at week 16, adipose tissue of liver will be mersured by Fibroscan, a device useing an ultrasound transducer probe to vibrations of liver presenting adipose tissue content.

  11. Homeostasis model assessment for insulin resistance(HOMA-IR)

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in HOMA-IR at week 16, HOMA-IR was calculated as \[fasting glucose (mmol/L)× fasting insulin (μU/ml)/22.5\].

  12. Homeostasis model assessment for β cell(HOMA-β)

    Time frame · From baseline to 16 week.

    Registry description

    Absolute changes from baseline in HOMA-β at week 16, HOMA-β was calculated as \[20× fasting insulin (μU/ml)/fasting glucose (mmol/L)-3.5\].

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Age between 18 to 70 years old from all sex; 2. Diagnosed with type 2 diabetes and HbA1c between 7% to 10%; 3. BMI from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）; 4. Volunteer to participate in the study with informed consent; Exclusion Criteria: 1. Type 1 diabetes or other specific types of diabetes; 2. Taking drugs of GLP-1 receptor agonist、TZDs and SGLT2 inhibitor within 3 months of screening; 3. Taking insulin or insulin analogues more than 7 days within 3 months of screening; 4. Pregnancy, breastfeeding or planned pregnancy; 5. History of acute or chronic pancreatitis; 6. Taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening; 7. 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; 8. renal impairment (estimated glomerular filtration rate\<60mL/min per 1.73 m²); 9. History of gastrointestinal disease; 10. History of malignant tumor within 5 years of screening; 11. History of organ transplantation or AIDS; 12. History of glaucoma; 13. History of hyperthyroidism or hypothyroidism; 14. History of medullary thyroid carcinoma or multiple endocrine neoplasia II; 15. History of abnormal of Calcitonin or thyroid tumor; 16. History of alcohol abuse; 17. Recruited by other clinical trials within 3 months of screening; 18. Taking drugs of weight loss within 3 months of screening; 19. History of bariatric surgery; 20. History of mental disorders; 21. History of rheumatic diseases or autoimmune diseases; 22. Allergic to beinaglutide or dulaglutide; 23. Participants who estimated would not be suitable for the study by the investigators.

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