DelfaGLP-1 Atlas

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CompletedPhase 2Results posted

Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus

Study 110933: Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

32

Recruiting sites

—

Enrollment

67

actual

Study population

Type 1 diabetes

Key I/E criterion

•BMI ≤32

Primary endpoint

•C-peptide AUC

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 IDNCT02284009
Org study ID110933

Timeline

Milestones

Study start2014-10-10actual
Study first posted2014-11-05estimated
Primary completion2017-10-18actual
Study completion2017-10-18actual
Results first posted2019-03-25actual
Last update posted2020-06-29actual

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age30 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18 to 30 years, inclusive, with a diagnosis of T1DM with an interval of 28-56 days between the initial diagnosis and the first dose of study drug. Documentation of the diagnosis of T1DM (and not just insulin deficiency), including the date of diagnosis, must be obtained from the diagnosing physician.
•Currently requires insulin for T1DM treatment, or has required insulin therapy for T1DM (for >=7 days) between the date of diagnosis and the first dose of study drug. Note: subjects currently taking twice daily commercially available pre-mixed insulin will not be eligible.
•Positive for at least one of the following autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase (anti-GAD) antibody to protein tyrosine phosphatase-like protein (anti-IA-2) or an insulin autoantibody (IAA). Please note: A subject who is positive for IAA and negative for the other autoantibodies will not be eligible if the subject has been using insulin for a total of >=7days.
•Evidence of residual functioning pancreatic beta-cells as measured by a peak stimulated C-peptide level > 0.20 nanomoles/litres (nmol/L) during the Screening MMTT when plasma glucose level is >3.9 mmol/L (70 mg/dL) and <=11.1 mmol/L (200 mg/dL). Note: the Screening MMTT should not be performed within one week of resolution of a DKA event.
•Body mass index <=32.0 kilogram/square meters (kg/m^2).
•Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (i.e., meeting one of the criteria defined below) from at least 14 days prior to the first dose of randomised study medication until the 12-week post-treatment Follow-up visit : Abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle; Oral Contraceptive, either combined or progestogen alone ; Injectable progestogen; Implants of etonogestrel or levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device or intrauterine system that has a failure rate of less than 1% per year when used consistently and correctly as stated in the product label; Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnel's review of subject's medical records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history.; Male condom combined with a female diaphragm, either with or without a vaginal spermicide
•Able and willing to provide written informed consent and to comply with all study procedures.

Exclusion criteria

•Severe gastroparesis i.e., requiring therapy within 6 months prior to Screening
•History of acute or chronic pancreatitis, or considered clinically at significant risk of developing pancreatitis, during the course of the study (e.g. due to symptomatic gallstones, excess alcohol use).
•History of significant gastrointestinal surgery that in the opinion of the investigator is likely to significantly affect upper gastrointestinal or pancreatic function (e.g. gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper gastrointestinal function)
•Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2)
•History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin, or treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
•Fasting triglyceride level >750 milligram/decilitre (mg/dL) at Screening. Subjects may be re-tested once during screening, and if the value no longer meets the exclusion criterion, the subject can be randomly assigned to treatment
•Estimated Glomerular Filtration Rate (eGFR) <=30 mL/min/1.73 m^2 (calculated using the Modification of Diet in Renal Disease (MDRD) formula
•Haemoglobinopathy that may affect proper interpretation of HbA1c
•Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) and bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
•Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). [Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and are not on active antiviral treatment (e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of screening)]
•Any clinically significant co-morbidity or abnormality (including psychiatric disorder, any other autoimmune endocrinopathy e.g., primary autoimmune hypothyroidism, hyperadrenalism, coeliac disease etc) that in the opinion of the Investigator, may pose additional risk in administering study medication or trial participation
•Female subject is pregnant (confirmed by laboratory testing) or lactating
•Known allergy to any GLP-1 analogue, insulin, or excipients of albiglutide
•Treatment with any oral anti-diabetic medication within the prior 30 days or 5 half lives of that medication, whichever is longer.
•Use of immunosuppressants, intravenous immunoglobulin, oral or systemically injected glucocorticoids within the 3 months before randomisation or high likelihood of a requirement for prolonged treatment (>1 week) in the year following randomisation. 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. Inhaled, intra-articular, and small quantities of non-potent topical corticosteroids are allowed
•Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational anti-diabetic drug within the 3 months before randomisation, or receipt of albiglutide in previous studies.

Endpoints (20)

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
12
Safety / tolerability / PK
6
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Body Weight (Kilograms) at Week 52

Time frame:Baseline and Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kilograms95% CI
Placebo0.26—
Albiglutide0.77—
Secondary/protocol endpoint

Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64)

Time frame:Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kilograms95% CI
PlaceboWeek 2,n=15, 4370.16—
Week 4,n=15, 4469.87—
Week 6,n=15, 4669.83—
Week 8,n=15, 4670.08—
Week 16,n=15, 4669.40—
Week 28,n=13, 4366.08—
Week 40,n=13, 4266.08—
Week 52,n=12, 4366.86—
Week 64,n=12, 4068.29—
AlbiglutideWeek 2,n=15, 4366.16—
Week 4,n=15, 4466.39—
Week 6,n=15, 4665.65—
Week 8,n=15, 4665.32—
Week 16,n=15, 4665.41—
Week 28,n=13, 4365.32—
Week 40,n=13, 4266.20—
Week 52,n=12, 4366.80—
Week 64,n=12, 4068.13—

Glycemic / diabetes

12 endpoints
Primary/protocol endpoint

Mean Change From Baseline in Time Normalized Stimulated (From Mixed Meal Tolerance Test [MMTT]) 2-hour Plasma C-peptide Area Under the Curve (AUC) at Week 52

Time frame:Baseline and Week 52

C-peptide AUC

change from baseline, improvement

Posted result

GroupValue (mean), Nanomoles per liter95% CI
Placebo-0.16—
Albiglutide-0.13—
DEFEND-1 Placebo-0.27—
Mean Difference (Final Values)0.1295% CI0.00 – 0.24
Secondary/protocol endpoint

Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64

Time frame:Baseline and Weeks 16, 28 and 64

C-peptide AUC

change from baseline, improvement

Posted result

GroupValue (mean), Nanomoles per liter95% CI
PlaceboWeek 16, n=15,440.00—
Week 28, n=13,41-0.14—
Week 64, n=11,36-0.22—
AlbiglutideWeek 16, n=15,440.07—
Week 28, n=13,410.01—
Week 64, n=11,36-0.22—
Secondary/protocol endpoint

Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64

Time frame:Baseline and Weeks 16, 28, 52 and 64

concentration, descriptive

Posted result

GroupValue (mean), Nanomoles per liter95% CI
PlaceboBaseline, n=15,460.86—
Week 16, n=15,450.84—
Week 28,n=13,420.68—
Week 52,n=11,410.63—
Week 64, n=11,370.58—
AlbiglutideBaseline, n=15,460.82—
Week 16, n=15,451.02—
Week 28,n=13,420.91—
Week 52,n=11,410.69—
Week 64, n=11,370.48—
Secondary/protocol endpoint

Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64

Time frame:Baseline and Weeks 16, 28, 52 and 64

plasma glucagon auc mmtt

change from baseline, improvement

Posted result

GroupValue (mean), Nanograms per liter95% CI
PlaceboWeek 16,n=15,45-2.28—
Week 28,n=13,43-2.97—
Week 52,n=11,40-0.31—
Week 64,n=11,373.19—
AlbiglutideWeek 16,n=15,45-1.10—
Week 28,n=13,433.91—
Week 52,n=11,404.66—
Week 64,n=11,378.82—
Secondary/protocol endpoint

Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64

Time frame:Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage of participants95% CI
PlaceboBaseline, n=15, 4626.7—
Week 4,n=14,4271.4—
Week 8,n=14,4685.7—
Week 16,n=15,4586.7—
Week 28,n=12,4275.0—
Week 40,n=13,4076.9—
Week 52,n=12,4141.7—
Week 64,n=11,3836.4—
AlbiglutideBaseline, n=15, 4637.0—
Week 4,n=14,4278.6—
Week 8,n=14,4667.4—
Week 16,n=15,4573.3—
Week 28,n=12,4273.8—
Week 40,n=13,4062.5—
Week 52,n=12,4148.8—
Week 64,n=11,3834.2—
Secondary/protocol endpoint

Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64

Time frame:Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
PlaceboBaseline, n= 15, 4673.3—
Week 4,n=14,4292.9—
Week 8,n=14,4692.9—
Week 16,n=15,4586.7—
Week 28,n=12,4275.0—
Week 40,n=13,4084.6—
Week 52,n=12,4158.3—
Week 64,n=11,3854.5—
AlbiglutideBaseline, n= 15, 4660.9—
Week 4,n=14,4288.1—
Week 8,n=14,4687.0—
Week 16,n=15,4586.7—
Week 28,n=12,4285.7—
Week 40,n=13,4082.5—
Week 52,n=12,4170.7—
Week 64,n=11,3855.3—
Secondary/protocol endpoint

Change From Baseline in Percent HbA1c at Week 52

Time frame:Baseline and Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage of HbA1c95% CI
Placebo-0.73—
Albiglutide-0.59—
Secondary/protocol endpoint

Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64)

Time frame:Weeks 4, 8, 16, 28, 40, 52 and 64

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage of HbA1c95% CI
PlaceboWeek 4,n=15,436.29—
Week 8,n=15,465.91—
Week 16,n=15,465.97—
Week 28,n=13,436.03—
Week 40,n=13,426.22—
Week 52,n=12,436.56—
Week 64,n=12,407.12—
AlbiglutideWeek 4,n=15,436.10—
Week 8,n=15,465.82—
Week 16,n=15,465.78—
Week 28,n=13,436.00—
Week 40,n=13,426.20—
Week 52,n=12,436.58—
Week 64,n=12,406.92—
Secondary/protocol endpoint

Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64

Time frame:Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64

change from baseline, improvement

Posted result

GroupValue (mean), Units/kg/day95% CI
PlaceboWeek 4,n=14,43-0.02—
Week 8,n=14,46-0.04—
Week 16,n=15,45-0.05—
Week 28,n=12,42-0.01—
Week 40,n=13,40-0.01—
Week 52,n=12,410.04—
Week 64,n=11,380.04—
AlbiglutideWeek 4,n=14,43-0.03—
Week 8,n=14,46-0.02—
Week 16,n=15,45-0.01—
Week 28,n=12,420.03—
Week 40,n=13,400.03—
Week 52,n=12,410.11—
Week 64,n=11,380.10—
Secondary/protocol endpoint

Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52

Time frame:Baseline and Weeks 28 and 52

CGM time-in-range

descriptive, improvement

Posted result

GroupValue (mean), hours per day95% CI
Placebo<= 3.9 mmol/L, Baseline,n=14,420.80—
<= 3.9 mmol/L, Week 28,n=12,361.72—
<= 3.9 mmol/L, Week 52,n=10,311.60—
> 3.9 to <= 10.0 mmol/L,Baseline,n=14,4220.14—
> 3.9 to <= 10.0 mmol/L,Week 28,n=12,3618.93—
> 3.9 to <= 10.0 mmol/L,Week 52,n=10,3117.98—
> 10.0 mmol/L, Baseline,n=14,423.06—
> 10.0 mmol/L,Week 28,n=12,363.35—
> 10.0 mmol/L,Week 52,n=10,314.42—
Albiglutide<= 3.9 mmol/L, Baseline,n=14,420.98—
<= 3.9 mmol/L, Week 28,n=12,361.38—
<= 3.9 mmol/L, Week 52,n=10,311.36—
> 3.9 to <= 10.0 mmol/L,Baseline,n=14,4219.11—
> 3.9 to <= 10.0 mmol/L,Week 28,n=12,3618.83—
> 3.9 to <= 10.0 mmol/L,Week 52,n=10,3118.19—
> 10.0 mmol/L, Baseline,n=14,423.90—
> 10.0 mmol/L,Week 28,n=12,363.79—
> 10.0 mmol/L,Week 52,n=10,314.45—
Secondary/protocol endpoint

Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52

Time frame:Baseline and Weeks 28 and 52

event count, improvement

Posted result

GroupValue (mean), Hyperglycemic excursions95% CI
PlaceboBaseline,n=15,430.80—
Week 28,n=13,401.23—
Week 52,n=12,401.17—
AlbiglutideBaseline,n=15,431.53—
Week 28,n=13,400.73—
Week 52,n=12,401.30—
Secondary/protocol endpoint

Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52

Time frame:Baseline and weeks 28 and 52

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
PlaceboBaseline,n=15,430.94—
Week 28,n=13,402.05—
Week 52,n=12,402.19—
AlbiglutideBaseline,n=15,432.72—
Week 28,n=13,401.52—
Week 52,n=12,402.42—

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52

Time frame:Week 24 to 52

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), Hypoglycemic events95% CI
PlaceboAny Significant Hypoglycemia472—
Severe Hypoglycemia0—
Documented Symptomatic Hypoglycemia241—
Asymptomatic Hypoglycemia231—
AlbiglutideAny Significant Hypoglycemia1592—
Severe Hypoglycemia0—
Documented Symptomatic Hypoglycemia996—
Asymptomatic Hypoglycemia596—
Secondary/protocol endpoint

Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52

Time frame:Baseline and Weeks 28 and 52

Documented hypoglycemia

event count, event

Posted result

GroupValue (mean), Hypoglycemic excursions95% CI
PlaceboBseline,n=15,420.40—
Week 28,n=13,400.31—
Week 52,n=12,400.25—
AlbiglutideBseline,n=15,420.36—
Week 28,n=13,400.28—
Week 52,n=12,400.40—
Secondary/protocol endpoint

Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52

Time frame:Baseline and Weeks 28 and 52

descriptive, event

Posted result

GroupValue (mean), mmol/L95% CI
PlaceboBaseline,n=15,420.24—
Week 28,n=13,400.18—
Week 52,n=12,400.22—
AlbiglutideBaseline,n=15,420.22—
Week 28,n=13,400.08—
Week 52,n=12,400.17—
Secondary/protocol endpoint

Population Estimates of Pharmacokinetic (PK) Parameters: Apparent Clearance [CL/F]

Time frame:48 hours after the most recent dose at Week 4, 6, 8 and 16

descriptive

Posted result

GroupValue (mean), Milliliters per hour95% CI
Albiglutide45.1—
Secondary/protocol endpoint

Population Estimates of PK Parameters: Apparent Volume of Distribution [V/F]

Time frame:48 hours after the most recent dose at Week 4, 6, 8 and 16

descriptive

Posted result

GroupValue (mean), Milliliters95% CI
Albiglutide4830—
Secondary/protocol endpoint/low confidence

Population Estimates of PK Parameters: First-order Absorption Rate Constant [Ka]

Time frame:48 hours after the most recent dose at Week 4, 6, 8 and 16

descriptive

Posted result

GroupValue (mean), Per hour95% CI
Albiglutide0.0122—

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.