DelfaGLP-1 Atlas

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CompletedPhase 1, PHASE2Results posted

Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes

Therapeutic Targets in African-American Youth With Type 2 Diabetes

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

24

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤9%

Primary endpoint

•Absolute Gluconeogenesis

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 IDNCT02960659
Org study ID170013
Secondary ID17-DK-0013NIH Clinical Center

Timeline

Milestones

Study first posted2016-11-10estimated
Study start2017-05-09actual
Primary completion2022-05-20actual
Study completion2022-05-20actual
Last update posted2023-08-01actual
Results first posted2023-08-01actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age25 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•INCLUSION CRITERIA:

1. Youth must self-identify as African-American and identify both parents as African-American

2. Age 12-25 years

3. Pubertal or post-pubertal: Girls Tanner stage IV-V breast; Boys Testicular volume 11-25cc

4. Diagnosis of type 2 diabetes of less than or equal to 5 years duration, as per American Diabetes Association Criteria

5. Hemoglobin A1C <9% at study initiation

6. Negative to mild ketonuria without acidosis (negative or 1+ ketones on urinalysis)

7. Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphatase-related islet antigen 2 (IA-2))

8. Willing and able to take daily medications and check blood glucose levels at least twice per day or wear a continuous glucose monitoring device (CGM).

Exclusion criteria

1. Pregnancy or breastfeeding

2. Allergy to study medications

3. Allergy to milk protein

4. Chronic insulin therapy

5. Treatment with other medications which are known to affect the parameters under study (for example sodium glucose transporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-IV) inhibitors, non-selective beta blockers).

6. Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood glucose greater than or equal to 200mg/dL), and/or liver enzymes > three times the upper limit of normal.

7. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2

8. Any other condition that, in the opinion of the investigators, will increase risk to the subject, or impede the accurate collection of study-related data.

9. Body weight greater than or equal to 450 lbs

10. Body weight less than or equal to 58kg

11. Serum triglyceride concentrations greater than or equal to 500mg/dl

12. Hemoglobin concentration <10g/dL

Endpoints (18)

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
10
Cardiometabolic biomarkers
4
Other (unclassified)
3
Safety / tolerability / PK
1

Glycemic / diabetes

10 endpoints
Primary/registry result

Change in Absolute Gluconeogenesis From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, improvement

Posted result

GroupValue (mean), mg/kg LBM/min95% CI
Metformin0.018—
Metformin and Liraglutide-0.050—
Primary/protocol endpoint

Change in Absolute Gluconeogenesis From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Change in Glucose Production Rate From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, improvement

Posted result

GroupValue (mean), mg/kg LBM/min95% CI
Metformin0.089—
Metformin and Liraglutide-0.101—
Secondary/registry result

Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (mean), 10^-4 mU/ml/min95% CI
Metformin0.023—
Metformin and Liraglutide0.020—
Secondary/registry result

Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, improvement

Posted result

GroupValue (mean), 1000mU/L/(μmol/min)95% CI
Metformin0.86—
Metformin and Liraglutide0.46—
Secondary/registry result

Change in Insulin AUC Concentrations During an OGTT and Meal Absorption

Time frame:Baseline to 12 weeks

change from baseline, descriptive

Posted result

GroupValue (mean), min*pmol/L95% CI
Metformin-6381—
Metformin and Liraglutide47831—
Secondary/protocol endpoint

Change in Glucose Production Rate From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Insulin AUC Concentrations During an OGTT and Meal Absorption

Time frame:Baseline to 12 weeks

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/registry result

Change in GIP AUC During OGTT and Meal Absorption

Time frame:Baseline to 12 weeks

GIP AUC OGTT

change from baseline, descriptive

Posted result

GroupValue (mean), pg*ml/min95% CI
Metformin-4432—
Metformin and Liraglutide-1476—
Secondary/registry result/low confidence

Change in Glycerol Turnover From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, descriptive

Posted result

GroupValue (mean), mg/kg LBM/min95% CI
Metformin-0.057—
Metformin and Liraglutide-0.030—
Secondary/registry result/low confidence

Change in Palmitate Turnover From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, descriptive

Posted result

GroupValue (mean), mg/kg LBM/min95% CI
Metformin0.003—
Metformin and Liraglutide-0.18—
Secondary/protocol endpoint

Change in Glycerol Turnover From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/registry result

Change in GLP-1 Area Under the Curve Concentrations (AUC) During OGTT and Meal Absorption

Time frame:Baseline to 12 weeks

concentration, descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change in GIP AUC During OGTT and Meal Absorption

Time frame:Baseline to 12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in GLP-1 Area Under the Curve Concentrations (AUC) During OGTT and Meal Absorption

Time frame:Baseline to 12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Palmitate Turnover From Baseline to 12 Weeks

Time frame:Baseline to 12 weeks

change from baseline, descriptive

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 tableClinicalTrials.gov results section

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.