GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

218

Recruiting sites

—

Enrollment

507

actual

Study population

Renal impairment, Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT01098539

Org study ID114130

Timeline

Milestones

Study first posted2010-04-02estimated

Results first posted2014-05-16estimated

Last update posted2017-02-28actual

Study start2010-05 (month precision)

Primary completion2012-11actual (month precision)

Study completion2012-11actual (month precision)

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Renal impairmentType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications

•BMI >/=20 kg/m2 and </=45 kg/m2

•Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)

•HbA1c between 7.0% and 10.0%, inclusive.

Exclusion criteria

•History of cancer

•History of treated diabetic gastroparesis

•Current biliary disease or history of pancreatitis

•History of significant gastrointestinal surgery

•Recent clinically significant cardiovascular and/or cerebrovascular disease

•History of human immunodeficiency virus infection

•Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C

•Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum

•Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast

•Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies

Endpoints (16)

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

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 26: LOCF

Time frame:Baseline; Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilograms	95% CI
Albiglutide 30 mg	-0.79	—
Sitagliptin 100 mg	-0.19	—

Secondary/protocol endpoint

Change From Baseline in Body Weight Through Week 26: LOCF

Time frame:Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms	95% CI
Albiglutide 30 mgWeek 1, n=225, 225	-0.17	—
Week 2, n=241, 238	-0.21	—
Week 3, n=244, 240	-0.25	—
Week 4, n=244, 240	-0.33	—
Week 8, n=244, 240	-0.58	—
Week 12, n=244, 240	-0.47	—
Week 16, n=244, 240	-0.63	—
Week 20, n=244, 240	-0.69	—
Sitagliptin 100 mgWeek 1, n=225, 225	0.12	—
Week 2, n=241, 238	-0.02	—
Week 3, n=244, 240	0.01	—
Week 4, n=244, 240	0.09	—
Week 8, n=244, 240	0.02	—
Week 12, n=244, 240	0.03	—
Week 16, n=244, 240	-0.08	—
Week 20, n=244, 240	-0.07	—

Secondary/protocol endpoint

Change From Baseline in Body Weight Through Week 52: OC

Time frame:Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms	95% CI
Albiglutide 30 mgWeek 1, n=225, 225	-0.17	—
Week 2, n=232, 227	-0.21	—
Week 3, n=236, 224	-0.24	—
Week 4, n=235, 230	-0.31	—
Week 8, n=226, 214	-0.61	—
Week 12, n=228, 219	-0.45	—
Week 16, n=223, 210	-0.68	—
Week 20, n=211, 198	-0.76	—
Week 26, n=202, 178	-0.87	—
Week 36, n=190, 155	-0.92	—
Week 48, n=172, 140	-0.93	—
Week 52, n=157, 119	-0.82	—
Sitagliptin 100 mgWeek 1, n=225, 225	0.12	—
Week 2, n=232, 227	-0.01	—
Week 3, n=236, 224	0.03	—
Week 4, n=235, 230	0.10	—
Week 8, n=226, 214	0.05	—
Week 12, n=228, 219	0.16	—
Week 16, n=223, 210	0.07	—
Week 20, n=211, 198	0.09	—
Week 26, n=202, 178	-0.04	—
Week 36, n=190, 155	0.01	—
Week 48, n=172, 140	0.07	—
Week 52, n=157, 119	0.31	—

Glycemic / diabetes

12 endpoints

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

Time frame:Baseline; Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c in the blood	95% CI
Albiglutide 30 mg	-0.83	—
Sitagliptin 100 mg	-0.52	—

Median Difference (Final Values)-0.3295% CI-0.49 – -0.15p<0.0001t-test, 1 sided

Secondary/protocol endpoint

Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF

Time frame:Baseline; Weeks 4, 8, 12, 16, and 20

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c in the blood	95% CI
Albiglutide 30 mgWeek 4, n=237, 234	-0.43	—
Week 8, n=242, 236	-0.60	—
Week 12, n=242, 236	-0.69	—
Week 16, n=242, 236	-0.75	—
Week 20, n=242, 236	-0.79	—
Sitagliptin 100 mgWeek 4, n=237, 234	-0.37	—
Week 8, n=242, 236	-0.52	—
Week 12, n=242, 236	-0.56	—
Week 16, n=242, 236	-0.56	—
Week 20, n=242, 236	-0.54	—

Secondary/protocol endpoint

Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases

Time frame:Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c in the blood	95% CI
Albiglutide 30 mgWeek 4, n=233, 228	-0.43	—
Week 8, n=222, 213	-0.63	—
Week 12, n=224, 216	-0.71	—
Week 16, n=218, 209	-0.75	—
Week 20, n=207, 196	-0.86	—
Week 26, n=202, 178	-0.93	—
Week 36, n=192, 155	-1.01	—
Week 48, n=172, 139	-1.01	—
Week 52, n=157, 118	-1.04	—
Sitagliptin 100 mgWeek 4, n=233, 228	-0.37	—
Week 8, n=222, 213	-0.56	—
Week 12, n=224, 216	-0.62	—
Week 16, n=218, 209	-0.63	—
Week 20, n=207, 196	-0.71	—
Week 26, n=202, 178	-0.80	—
Week 36, n=192, 155	-0.82	—
Week 48, n=172, 139	-0.89	—
Week 52, n=157, 118	-1.03	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Time frame:Baseline; Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), Millimoles per liter (mmol/L)	95% CI
Albiglutide 30 mg	-1.42	—
Sitagliptin 100 mg	-0.22	—

Secondary/protocol endpoint

Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF

Time frame:Baseline; Weeks 4, 8, 12, 16, 20, and 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Albiglutide 30 mgWeek 4, n=244, 240	-1.47	—
Week 8, n=244, 240	-1.19	—
Week 12, n=244, 240	-1.35	—
Week 16, n=244, 240	-1.34	—
Week 20, n=244, 240	-1.37	—
Sitagliptin 100 mgWeek 4, n=244, 240	-0.84	—
Week 8, n=244, 240	-0.82	—
Week 12, n=244, 240	-0.81	—
Week 16, n=244, 240	-0.49	—
Week 20, n=244, 240	-0.62	—

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC

Time frame:Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Albiglutide 30 mgWeek 1, n=219, 217	-0.82	—
Week 2, n=226, 223	-1.28	—
Week 3, n=230, 219	-1.25	—
Week 4, n=231, 226	-1.55	—
Week 8, n=221, 210	-1.24	—
Week 12, n=224, 216	-1.46	—
Week 16, n=214, 204	-1.41	—
Week 20, n=207, 191	-1.51	—
Week 26, n=200, 177	-1.54	—
Week 36, n=186, 149	-1.42	—
Week 48, n=165, 140	-1.08	—
Week 52, n=149, 114	-1.06	—
Sitagliptin 100 mgWeek 1, n=219, 217	-0.93	—
Week 2, n=226, 223	-0.66	—
Week 3, n=230, 219	-0.88	—
Week 4, n=231, 226	-0.76	—
Week 8, n=221, 210	-0.74	—
Week 12, n=224, 216	-0.88	—
Week 16, n=214, 204	-0.55	—
Week 20, n=207, 191	-1.00	—
Week 26, n=200, 177	-0.58	—
Week 36, n=186, 149	-0.92	—
Week 48, n=165, 140	-0.58	—
Week 52, n=149, 114	-0.96	—

Secondary/protocol endpoint

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
Albiglutide 30 mgHbA1c <6.5%	37	—
HbA1c <7.0%	103	—
Sitagliptin 100 mgHbA1c <6.5%	29	—
HbA1c <7.0%	72	—

Secondary/protocol endpoint

Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF

Time frame:Week 26

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
Albiglutide 30 mgHbA1c >=1.0%	102	—
HbA1c >=1.5%	49	—
HbA1c >=2.0%	26	—
Sitagliptin 100 mgHbA1c >=1.0%	77	—
HbA1c >=1.5%	38	—
HbA1c >=2.0%	17	—

Secondary/protocol endpoint

Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
Albiglutide 30 mgHbA1c <6.5%	44	—
HbA1c <7.0%	98	—
Sitagliptin 100 mgHbA1c <6.5%	27	—
HbA1c <7.0%	61	—

Secondary/protocol endpoint

Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC

Time frame:Week 52

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
Albiglutide 30 mgHbA1c >=1.0%	79	—
HbA1c >=1.5%	43	—
HbA1c >=2.0%	20	—
Sitagliptin 100 mgHbA1c >=1.0%	65	—
HbA1c >=1.5%	30	—
HbA1c >=2.0%	15	—

Secondary/protocol endpoint

Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52

Time frame:Week 2 to Week 52

time to event, event

Posted result

Group	Value (number), Participants	95% CI
Albiglutide 30 mgWeek 2	0	—
Week 4	0	—
Week 8	1	—
Week 12	2	—
Week 16	5	—
Week 20	9	—
Week 26	15	—
Week 36	25	—
Week 48	33	—
Week 52	44	—
Sitagliptin 100 mgWeek 2	2	—
Week 4	2	—
Week 8	3	—
Week 12	5	—
Week 16	6	—
Week 20	14	—
Week 26	29	—
Week 36	47	—
Week 48	53	—
Week 52	68	—

Secondary/protocol endpoint

Time to Hyperglycemic Rescue Through Week 52

Time frame:Week 2 to Week 52

time to event, event

Posted result

Group	Value (median), Weeks	95% CI
Albiglutide 30 mg	NA	NA – NA
Sitagliptin 100 mg	NA	NA – NA

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16

Time frame:Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (mean), nanograms per milliliter (ng/mL)	95% CI
Albiglutide 30 mgWeek 8, Pre-dose, n=223	3005.80	—
Week 8, Post-dose, n=220	3452.62	—
Week 16, Pre-dose, n=215	2994.15	—
Week 16, Post-dose, n=205	3583.06	—

Publications (2)

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

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Clinical pharmacology of albiglutide, a GLP-1 receptor agonist.
Postgraduate medicine2014 Nov (month)PMID25387217doi:10.3810/pgm.2014.11.2836via clinicaltrials gov reference derived + pubmed nct search

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.