DelfaGLP-1 Atlas

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CompletedPhase 4

Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes

Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes : a Randomised Open Parallel-controlled Study

Lead sponsor

Xijing Hospital

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

150

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 21-35•HbA1c 7.5-10%

Primary endpoint

•Mean amplitude of glycemic excursions

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 IDNCT02449603
Org study IDESR-14-10319

Timeline

Milestones

Study first posted2015-05-20estimated
Last update posted2018-11-14actual
Study start2015-11actual (month precision)
Primary completion2018-04actual (month precision)
Study completion2018-04actual (month precision)

Assets

Investigational agents

Exenatide

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

•Provision of informed consent prior to any study specific procedures.
•Men and women (non-pregnant and using a medically approved birth-control method) aged between 18 and 70 years at screening.
•Confirmed type 2 diabetes with history of at least half a year.
•Treatment with stable, maximum tolerated doses of metformin (≧1500mg/d, ≧3 months).
•HbA1c ≥ 7.5% and ≤ 10.0% at screening or within 4 weeks prior to screening (by local laboratory).
•Body mass index: 21-35 kg/m^2.

Exclusion criteria

•Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
•Diagnosis or history of:

1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, e.g., acromegaly or Cushing's syndrome.

2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.

•Previous treatment with any dipeptide peptidase-4 (DPP4) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonists within the past one year.
•History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptide peptidase-4 inhibitor (DPP4) or Acarbose.
•Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 3months prior to screening.
•Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months.
•Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening (by local laboratory).
•Patients with clinically apparent liver disease characterized by either one of the following:

1. Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN) confirmed on two consecutive measurements (by local laboratory) within 4 weeks prior to screening period

2. Impaired excretory (e.g. hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices.

3. Acute viral or active autoimmune, alcoholic, or other types of hepatitis.

•Patients with moderate /severe renal impairment or end-stage renal disease (estimated Glomerular Filtration Rate ≤ 60 mL/min calculated by using the abbreviated equation developed by the Modification of Diet in Renal Disease (MDRD) study with modification for the Chinese population) at screening or within 4 weeks prior to screening (by local laboratory)
•Congestive heart failure defined as New York Heart Association (NYHA) class III or IV.
•Significant cardiovascular history within the past 3 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.
•History of chronic pancreatitis or idiopathic acute pancreatitis.
•History of gastrointestinal disease including gastroenterostomy, enterectomy, Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer.
•History of genetic galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
•History of medullary thyroid carcinoma.
•Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years.
•History of organ transplant or acquired immunodeficiency syndrome (AIDS).
•History of alcohol abuse or illegal drug abuse within the past 12 months.
•Potentially unreliable patients and those judged by the Investigator to be unsuitable for the study.

Endpoints (12)

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

Cardiometabolic biomarkers
4
Safety / tolerability / PK
3
Weight & body composition
2
Glycemic / diabetes
2
Renal / kidney
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body mass index

Time frame:at baseline and Week 16

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:at baseline and Week 16

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Change of mean amplitude of glycemic excursions

Time frame:from baseline to Week 16

change from baseline, improvement

Secondary/protocol endpoint

HbA1c

Time frame:at baseline and Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Urinary albumin

Time frame:at baseline and Week 16

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Blood pressure

Time frame:at baseline and Week 16

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Lipids

Time frame:at baseline and Week 16

change from baseline, improvement

Secondary/protocol endpoint

Monocyte chemotactic protein-1 (MCP-1)

Time frame:at baseline and Week 16

change from baseline, improvement

Secondary/protocol endpoint

High-sensitivity C-reactive protein (hs-CRP)

Time frame:at baseline and Week 16

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Hours of hypoglycemia as measured by continuous glucose monitoring system (CGMS)

Time frame:at baseline and Week 16

descriptive, event

Secondary/protocol endpoint

Number of participants with adverse events/severe adverse events

Time frame:from baseline to Week 16

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of participants with clinical hypoglycemia

Time frame:from baseline to Week 16

event count, event

Publications (2)

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.