GLP-1 Peptide Atlas, by Delfa

WithdrawnPhase 3

A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus

A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Albiglutide for the Treatment of Type 2 Diabetes Mellitus in Pediatric Patients

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c ≤10%•Age 10-17

Primary endpoints

•Area under the curve (AUC) of albiglutide•Cmax of albiglutide•Apparent clearance (CL/F) of albiglutide

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 IDNCT03015519

Org study ID200938

Timeline

Milestones

Study first posted2017-01-10estimated

Study start2017-08-14estimated

Last update posted2019-01-17actual

Primary completion2020-04-20estimated

Study completion2020-04-20estimated

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Between 10 to less than 18 years of age inclusive at the time of screening.

•Diagnosis of T2DM with HbA1c more than or equal to 7.0% [53 millimole per mole (mmol/mol)] and less than 10.0% (85.8 mmol/mol) assessed at screening. Currently treated with regimen of diet and exercise with or without metformin. Subjects on metformin monotherapy should have been treated for a minimum of 8 weeks prior to randomization on a dose above 1000 milligram per day (mg/day) or prior documented maximum tolerated dose (MTD) less than or equal to 1000 mg/day.

•FPG less than 240 mg/deciliter (dL) at screening.

•Fasting C-peptide more than or equal to 0.8 nanogram per milliliter (ng/mL) at screening.

•Negative central laboratory assays for Glutamic Acid Decarboxylase 65 (GAD-65) and Islet Cell Autoantigen 512 (ICA512) autoantibodies at screening.

•Body weight more than or equal to 30 kilogram (kg) at screening.

•Male subjects will be included. Female subjects who have achieved menarche and are of childbearing potential must be practicing adequate contraception for the duration of participation in the study.

•Signed informed consent of parent or legal guardian and assent as appropriate will be obtained from the child.

Exclusion criteria

•Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM)

•Female subject is pregnant (confirmed by laboratory testing), planning a pregnancy or lactating.

•History of cancer that has not been in full remission for at least 3 years before screening.

•History of thyroid cancer.

•Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2).

•History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones).

•Severe gastroparesis within 6 months prior to screening.

•History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function.

•Have a history of at least one episode of diabetic ketoacidosis (DKA) after receiving anti-diabetic medication.

•Fasting triglyceride level more than 750 mg/dL at screening.

•Serum calcitonin more than 50 picogram (pg/mL) at screening.

•Hemoglobinopathy that may affect determination of HbA1c.

•Uncontrolled hypertension at screening.

•Estimated Glomerular Filtration Rate (eGFR) less than 90 mL/minute/1.73 meter^2 (calculated using the Schwartz equation) at screening.

•ALT more than 2.5x upper limit of normal (ULN) or Bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening.

•Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).

•Current or previous insulin therapy used for more than 4 weeks (continuously) in the 3 months prior to screening.

•Use of a GLP-1receptor agonist at study entry and during the study.

•Any oral diabetic medications, except metformin, at study entry and during the study.

•Use of oral or systemically injected glucocorticoids is generally not allowed within the 3 months before randomization; however, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor.

•Weight loss medications.

•Antiretroviral drugs.

•Known allergy or serious hypersensitivity reaction to albiglutide or any product components (including yeast and human albumin), any other GLP 1 analogue, insulin, or other study medication's excipients or other contraindications.

•Any other reason the investigator deems the subject to be unsuitable for the study or may interfere with trial compliance (e.g. significant medical or psychiatric history).

•The subject has participated in a clinical trial and has received an investigational product or device within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

Endpoints (25)

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

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 24: Part B

Time frame:Up to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in fasting Plasma Glucose (FPG): Part B

Time frame:Up to Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of subjects reaching HbA1c less than 7%: Part B

Time frame:Up to Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time to hyperglycemia rescue: Part B

Time frame:Up to Week 24

time to event, event

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Assessment of Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP): Part B

Time frame:Up to Week 60

change from baseline, improvement

Secondary/protocol endpoint

Assessment of pulse rate: Part B

Time frame:Up to Week 60

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) diabetes module total score: Part B

Time frame:Up to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Children's Depression Inventory 2 Self Report Short Version [CDI 2: SR(S)]

Time frame:Up to Week 52

change from baseline, improvement

Safety / tolerability / PK

17 endpoints

Primary/protocol endpoint

Area under the curve (AUC) of albiglutide: Part A

Time frame:Up to 28 days post-dose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax) of albiglutide: Part A

Time frame:Up to 28 days post-dose

Cmax

concentration, descriptive

Primary/protocol endpoint

Apparent clearance (CL/F) of albiglutide: Part A

Time frame:Up to 28 days post-dose

descriptive

Primary/protocol endpoint

Apparent volume of distribution (V/F) of albiglutide: Part A

Time frame:Up to 28 days post-dose

descriptive

Primary/protocol endpoint

Number of subjects with adverse events (AEs): Part A

Time frame:Up to Week 8 post dose

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Time to reach maximum plasma concentration (tmax) of albiglutide: Part A

Time frame:Up to 28 days post-dose

Tmax

descriptive

Primary/protocol endpoint

Time to reach half of the maximum plasma concentration (t1/2) of albiglutide: Part A

Time frame:Up to 28 days post-dose

Half-life

descriptive

Secondary/protocol endpoint

Number of subjects with AEs, serious adverse events (SAEs): Part B

Time frame:Up to Week 60

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Number of hypoglycemic episodes: Part B

Time frame:Up to Week 60

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Evaluation of immunogenicity: Part B

Time frame:Up to Week 60

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Change from Baseline in serum calcitonin levels: Part B

Time frame:Up to Week 52

Thyroid event

change from baseline, event

Secondary/protocol endpoint

Number of subjects with abnormal clinical laboratory parameters: Part B

Time frame:Up to Week 60

event count, event

Secondary/protocol endpoint

Number of subjects with abnormal growth and development: Part B

Time frame:Up to Week 52

event count, event

Secondary/protocol endpoint

CL/F of albiglutide: Part B

Time frame:Up to Week 24

descriptive

Secondary/protocol endpoint

V/F of albiglutide: Part B

Time frame:Up to Week 24

concentration, descriptive

Secondary/protocol endpoint

First-order absorption rate constant(Ka): Part B

Time frame:Up to Week 24

descriptive

Secondary/protocol endpoint

Number of subjects showing covariate relationship between PK and clinical measure of interest: Part B

Time frame:Up to Week 24.

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.