GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4

Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM

Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Switching Premix Human Insulin to Aspart30 in T2DM With Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel Trial

Lead sponsor

Huazhong University of Science and Technology

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

349

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-35•HbA1c 8-11%

Primary endpoint

•HbA1c, change

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 IDNCT02467920

Org study IDESR-14-10352

Timeline

Milestones

Study first posted2015-06-10estimated

Last update posted2018-11-14actual

Study start2015-08actual (month precision)

Primary completion2017-12actual (month precision)

Study completion2017-12actual (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

•Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 U/d and metformin with maximum tolerated dosage (≤ 1500mg/d)

•HbA1c > 8.0 % and < 11.0 % (HbA1c > 7.0 % and < 10.0% at randomization)

•Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years

•BMI ≥ 23 and ≤ 35 kg/m2

Exclusion criteria

•Type 1 diabetes or other specific types of diabetes

•Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods

•Uncooperative subject because of various reasons

•Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal

•Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male

•Serious chronic gastrointestinal diseases

•Edema

•Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction

•Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg

•White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L，or definite anemia (Hb：< 120g/L for male, < 110g/L for female), or other hematological diseases

•Endocrine system diseases, such as hyperthyroidism and hypercortisolism

•Experimental drug allergy or frequent hypoglycemia

•Psychiatric disorders, drug or other substance abuse

•Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy

•Stressful situations such as surgery, serious trauma and so on

•Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease

•Combined use of drugs effecting glucose metabolism such as glucocorticoid

•Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria

Endpoints (7)

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

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:from baseline to 12 and 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.

Time frame:from baseline to 24-week endpoint

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c from baseline to 12 weeks endpoint

Time frame:from baseline to 12 weeks endpoint

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%

Time frame:12 weeks and 24 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting blood glucose

Time frame:12 weeks and 24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

The incidence and rate of hypoglycaemic events during the study

Time frame:baseline, 12 weeks and 24 weeks

Documented hypoglycemia

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Daily insulin use

Time frame:baseline, 12 weeks and 24 weeks

descriptive

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.