DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT03829891

CompletedPhase NA

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

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

Lead sponsor

Xijing Hospital

Asset

Beinaglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

60

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤35•HbA1c ≤11%

Primary endpoints

•Fasting glucose, change•HbA1c <7.0% achievement•Changes of blood sugar variation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03829891
Org study IDKY20182008-1

Timeline

Milestones

Study start2018-08-07actual
Study first posted2019-02-04actual
Primary completion2019-12-31actual
Study completion2020-12-04actual
Last update posted2022-01-19actual

Assets

Investigational agents

Beinaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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.
–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.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
5
Weight & body composition
3
Cardiometabolic biomarkers
3
Safety / tolerability / PK
2
Other (unclassified)
2

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change of body weight report in kilograms

Time frame:Baseline and week16

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and week16

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist-hip ration change

Time frame:Baseline and week16

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

The proportion and rate of the fasting blood glucose control.

Time frame:Baseline and week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Proportion of patients with glycosylated hemoglobin < 7%.

Time frame:Baseline and week 16

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Primary/protocol endpoint/low confidence

Changes of blood sugar variation .

Time frame:Baseline and week 16

change from baseline, improvement

Secondary/protocol endpoint

Change percentage of glycosylated hemoglobin

Time frame:Baseline and week16

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change of blood glucose

Time frame:Baseline and week16

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change of blood pressure

Time frame:Baseline and week16

change from baseline, improvement

Secondary/protocol endpoint

Change of blood lipids

Time frame:Baseline and week16

change from baseline, improvement

Secondary/protocol endpoint

Inflammatory factors (hs-CRP) change

Time frame:Baseline and week16

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Safety Outcome Measure: Adverse Event

Time frame:From baseline to week 16

Treatment-emergent AEs (any)

descriptive, event

Other/protocol endpoint

Safety Outcome Measure: Serious adverse event

Time frame:From baseline to week 16

Serious AEs (any)

descriptive, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Oxidative Stress Indice (8-Iso-PGF2α) change

Time frame:Baseline and week16

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Inflammatory factors (MCP-1) change

Time frame:Baseline and week16

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.