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Type 2 Diabetes MellitusNCT03829891

Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus

A study testing Beinaglutide and glargine in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators aimed to assess the efficacy and safety of Beinaglutide versus glargine , in individuals with type 2 diabetes who did not achieve adequate glycaemic control with oral antidiabetic drug. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Beinaglutide and glargine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesChina
Study dates
7 Aug 2018to 4 Dec 2020
Phase
Interventional
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

  • Informed consent obtained before any trial-related activities
  • Male or female between the age of 18 and 70 years by the time of visit 1
  • Have been diagnosed as type 2 diabetes for at least half a year
  • Prestudy combination OAD therapy for at least 1 month(except glinides, DPP-VI inhibitor,insulin,GLP-1 receptor agonists ),
  • The dose of Sulfonylureas less than the half maximum dose of insert
  • 7.5%≤HbA1c≤11.0% in recent 2 weeks or on visit 1(local lab test)
  • 21Kg/m2≤BMI≤35Kg/m2

Who cannot join

  • Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods .
  • Current diagnosis or history of following:
  • Type 1 diabetes
  • Diabetes caused by impaired pancreas
  • Diabetes is the secondary diagnosis ,such as acromegaly,Cushing syndrome etc.
  • Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg. diabetes ketoacidosis, hyperosmolar coma) within 6months prior to screening.
Show all 23Show fewer
  • Use of any glinides, DPP-VI inhibitor,GLP-1 receptor agonists within 3months prior to screening.Use of any insulin within 1months prior to screening.
  • History of allergy (such as systemic allergy, Vascular neuroedema, epidermal exfoliation, etc.)
  • Systemic use of glucocorticoids (oral or intravenous) continued for more than seven days in the past half year.
  • Triglyceride (fasting)> 4.5mmol/L at visit 1.
  • Impaired liver function,such as manifested in one of the following situations:
  • Two consecutive measurements of AST or ALT in the first four weeks of the visit exceeded the maximum normal value by more than three times (local laboratory data)
  • Bilirubin synthesis and/or excretion disorders (such as hyperbilirubinemia) and other decompensated liver diseases such as coagulation,Blood disorders, hepatic encephalopathy, hypoproteinemia, ascites, esophageal variceal bleeding
  • Acute viral, active autoimmune, alcoholic and other types of hepatitis
  • Moderate to severe renal impairment or end-stage renal disease (estimated kidney) at visit or 4 weeks before visit (local data)Globular filtration rate < 60 mL/minNew York Heart Association (NYHA) Class III or IV congestive heart failure
  • Visit 1 has a major history of cardiovascular disease in the past three months, defined as myocardial infarction, coronary angioplasty or bypass surgery, valvular disease or repair, unstable angina, transient ischemic attack or cerebrovascular accident.
  • History of acute or chronic pancreatitis
  • History of gastrointestinal diseases, including gastrointestinal stoma anastomosis, intestinal resection, gastric cardiac syndrome, severe hernia, intestinal obstruction, intestinal ulcer
  • Malignant tumors (except cutaneous basal cell carcinoma, cervical carcinoma in situ and prostate cancer in situ) have been diagnosed in the past five years.
  • History of organ transplantation or AIDS
  • History of medullary thyroid cancer
  • History of alcohol or drug abuse in the past 12 months
  • Individuals or researchers who do not comply with the potential risks of the program are judged to be unsuitable for the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Chang'an Hospital

    Xi'an, China,Shanxi, 710016

  • Shaanxi Aerospace Hospital

    Xi'an, China,Shanxi, 710025

Other trials in China

About this study

Official title: A Randomized, Open-label, Controlled,Parallel-group Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus

The investigators aimed to assess the efficacy and safety of Beinaglutide versus glargine , in individuals with type 2 diabetes who did not achieve adequate glycaemic control with oral antidiabetic drug.

Read the detailed description

The investigators wonder in clinical hypoglycemic treatment for patients with hyperglycemia, whether to reduce fasting blood glucose or postprandial blood glucose first.

In this study, subjects with type 2 diabetes mellitus in combination with oral medication will be treated with basic insulin to reduce fasting blood glucose, or with beinaglutide to reduce postprandial blood glucose, in order to find out which one of controling blood glucose can be more effective and observe the change of blood fluctuation.

Being tested
Beinaglutide, glargine
Keywords
Type 2 Diabetes Mellitus, Beinaglutide, glycemic variability
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • BeinaglutideDrug

    1. Beinaglutide for 8 weeks,
    2. Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )

  • glargineDrug

    1. Glargine for 8 weeks,
    2. Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )
Study groups in NCT03829891
Study groupRoleWhat they receive
BeinaglutideExperimental1. Beinaglutide for 8 weeks, 2. Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )
Receives: Drug: Beinaglutide; Drug: glargine
glargineActive comparator1. Glargine for 8 weeks, 2. Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )
Receives: Drug: Beinaglutide; Drug: glargine

What is being measured

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

  1. The proportion and rate of the fasting blood glucose control.

    Measured: Baseline and week 16

  2. Proportion of patients with glycosylated hemoglobin < 7%.

    Measured: Baseline and week 16

  3. Changes of blood sugar variation .

    Measured: Baseline and week 16

Secondary outcomes (10)

  1. Change percentage of glycosylated hemoglobin

    Measured: Baseline and week16

  2. Change of blood glucose

    Measured: Baseline and week16

  3. Change of blood pressure

    Measured: Baseline and week16

  4. Change of blood lipids

    Measured: Baseline and week16

  5. Change of body weight report in kilograms

    Measured: Baseline and week16

  6. Change of body mass index report in kg/m^2

    Measured: Baseline and week16

  7. Waist-hip ration change

    Measured: Baseline and week16

  8. Oxidative Stress Indice (8-Iso-PGF2α) change

    Measured: Baseline and week16

  9. Inflammatory factors (MCP-1) change

    Measured: Baseline and week16

  10. Inflammatory factors (hs-CRP) change

    Measured: Baseline and week16

Timeline

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

  1. First posted4 Feb 2019
  2. Study start7 Aug 2018
  3. Primary completion31 Dec 2019
  4. Study completion4 Dec 2020

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829891
Sponsor's protocol ID
KY20182008-1
Status last verified
Aug 2020
First submitted
27 Jan 2019
Last updated
19 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu X, Yang W, Liu J, Huang X, Fang Y, Ming J, Lai J, Fu J, Ji Q, Wang L. The efficacy and safety of beinaglutide alone or in combination with insulin glargine in Chinese patients with type 2 diabetes mellitus who are inadequately controlled with oral antihyperglycemic therapy: A multicenter, open-label, randomized trial. J Diabetes. 2023 Oct 20;16(2):e13483. doi: 10.1111/1753-0407.13483. Online ahead of print.

    PubMed 37864379

Questions about this trial

What is this clinical trial studying?

A study testing Beinaglutide and glargine in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 2 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 7 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: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion and rate of the fasting blood glucose control. (time frame: Baseline and week 16). The study lists 3 primary outcomes in all. 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 NCT03829891, which also lists 1 linked publication.

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 19 Jan 2022.

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