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Diabetes Mellitus, Type 2Phase 4NCT05005741

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

A Phase 4 study testing Beinaglutide and Dulaglutide in people with Diabetes Mellitus, Type 2 and Overweight or Obesity, run by Second Xiangya Hospital of Central South University at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Beinaglutide and Dulaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
4 sitesChina
Study dates
1 May 2021to 31 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 23Show fewer
  • 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;
  • History of alcohol abuse;
  • Recruited by other clinical trials within 3 months of screening;
  • Taking drugs of weight loss within 3 months of screening;
  • History of bariatric surgery;
  • History of mental disorders;
  • History of rheumatic diseases or autoimmune diseases;
  • Allergic to beinaglutide or dulaglutide;
  • Participants who estimated would not be suitable for the study by the investigators.

Trial locations and contacts

4 sites in 1 country.

Zhiguang Zhou, MD/PhD contact

86-731-85292154

zhouzg@hotmail.com

China4 sites, 4 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Zhiguang Zhou, MD/PhD, 86-731-85292154, zhouzg@hotmail.com

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled, Open-label, Multi-center Study With 16-week Beinaglutide or Dulaglutide Assessing Effects on Glucose Control and Weight Loss in Type 2 Diabetes With Overweight or Obesity.

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.

Read the detailed description

About 2/3 of patients with type 2 diabetes are overweight or obese in China, several studies had confirmed that overweight and obesity could cause type 2 diabetes. GLP-1 receptor agonist could control diabetes meanwhile loss the patient weight. This is a multi-center, openlabel, 1:1 randomized controlled trial to investigate the differences of glucose control and weight loss between two GLP-1 receptor agonist, Beinaglutide and Dulaglutide, in type 2 diabetes with overweight or Obesity. The study comprises the 0-2 weeks of screening period and the 16-week intervention period. 120 patients according to the inclusion/exclusion criteria would recruit from 4 sites in China, then the participant will be randomized to three times a day of subcutaneous beinaglutide(dose escalate to 0.2mg), or once-weekly of 1.5mg subcutaneous dulaglutide for 16-week. The primary endpoint is the change from baseline to week 16 in HbA1c. The second endpoint is the change from baseline to week 16 in weight.

Being tested
Beinaglutide, Dulaglutide
Keywords
GLP-1 receptor agonist, Beinaglutide, Dulaglutide, Type 2 diabetes, HbA1c
Medical subject headings
Diabetes Mellitus, Type 2, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BeinaglutideDrug

    Also called GLP-1 receptor agonist

    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.

  • DulaglutideDrug

    Also called Trulicity, GLP-1 receptor agonist

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

Study groups in NCT05005741
Study groupRoleWhat they receive
BeinaglutideExperimentalNot described
Receives: Drug: Beinaglutide
DulaglutideActive comparatorNot described
Receives: Drug: Dulaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. haemoglobin A1c(HbA1c)

    Absolute changes from baseline in HbA1c at week 16.

    Measured: From baseline to 16 week.

Secondary outcomes (12)

  1. Weight loss

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

    Measured: From baseline to 16 week.

  2. GLucose

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

    Measured: From baseline to 16 week.

  3. Body Mass Index(BMI)

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

    Measured: From baseline to 16 week.

  4. Waistline

    Absolute changes from baseline in waistline at week 16.

    Measured: From baseline to 16 week.

  5. Hipline

    Absolute changes from baseline in hipline at week 16.

    Measured: From baseline to 16 week.

  6. Serum total cholesterol

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

    Measured: From baseline to 16 week.

  7. Serum triglycerides

    Absolute changes from baseline in triglycerides at week 16.

    Measured: From baseline to 16 week.

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

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

    Measured: From baseline to 16 week.

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

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

    Measured: From baseline to 16 week.

  10. Adipose tissue of liver

    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.

    Measured: From baseline to 16 week.

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

    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].

    Measured: From baseline to 16 week.

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

    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].

    Measured: From baseline to 16 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2021
  2. Study start1 May 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05005741
Sponsor's protocol ID
BENEFIT 1
Status last verified
Mar 2023
First submitted
9 Aug 2021
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beinaglutide and Dulaglutide in people with Diabetes Mellitus, Type 2 and Overweight or Obesity, run by Second Xiangya Hospital of Central South University at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhiguang Zhou, MD/PhD (86-731-85292154, zhouzg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

haemoglobin A1c(HbA1c) (time frame: From baseline to 16 week.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05005741.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.

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