GLP-1 Peptide Atlas, by Delfa

UnknownPhase 4

Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus

Pilot Study for Evaluation of the Impact of Intensive Short-Term Drug Therapy on Beta-Cell Function and Insulin Resistance in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Sciema UG

Assets

Exenatide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤10%

Primary endpoint

•Impact of a temporary personalized poly-pharmaceutical treatment on the disease

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 IDNCT04027023

Org study IDDCTI-DET-001

Timeline

Milestones

Study first posted2019-07-19actual

Study start2019-10-30actual

Last update posted2021-04-01actual

Primary completion2021-04-30estimated

Study completion2021-05-31estimated

Assets

Investigational agents

Exenatide Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained prior to any trial-related activities

•Male or female > 18 years

•Diagnosed with 2 Diabetes

•HbA1c <10%

•Current treatment with diet and exercise or up to two anti-diabetic drugs

Exclusion criteria

•Patients participating in another investigational drug study

•Drug or alcohol abuse

•Pregnancy or breast feeding

•Sexually active woman of childbearing age not practicing accepted birth control

•Severe diabetes complications (in the discretion of investigator)

•Unstable significant cardiovascular disease with admission to emergency room or hospital in last 45 days

•Lack of compliance or other reason that in the discretion of the investigator precludes satisfactory participation in the study

•Any severe illness preventing participation in the study per protocol (in the discretion of the investigator)

Endpoints (11)

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

Other (unclassified)

Glycemic / diabetes

MASH / liver

Renal / kidney

Patient-reported / QoL

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

insulin, c-peptide, intact proinsulin, glucagon will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on beta-cell function

Time frame:12 weeks

descriptive

MASH / liver

1 endpoint

Secondary/protocol endpoint

Liver function

Time frame:12 weeks

change from baseline, improvement

componentsAST, change, ALT, change, γ-GT, change

Renal / kidney

1 endpoint

Secondary/protocol endpoint/low confidence

Renal function

Time frame:12 weeks

descriptive

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

the biomarker adiponectin will be measured to evaluate the impact of the poly-pharmaceutical treatment on the adiponectin level

Time frame:12 weeks

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

hsCRP, IL-6, angiopoetin 2 will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on biomarkers of inflammation

Time frame:12 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint/low confidence

Heart function

Time frame:12 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Questionnaire about the diabetes treatment satisfaction (DTSQ) will be filled by the patient to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on the quality of Life

Time frame:12 weeks

PGI, change

change from baseline, improvement

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes

Time frame:12 weeks

categorical status, improvement

Secondary/protocol endpoint/low confidence

RBP4 will be measured to evaluate the impact of the poly-pharmaceutical treatment on the RBP4 level

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Electrolytic balance

Time frame:12 weeks

change from baseline, descriptive

componentssodium, potassium, calcium

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.