Primary outcome
What NCT01128894 measured first
| Albiglutide 50 mgn=398 | Liraglutide 1.8 mgn=402 |
|---|---|
| -0.78(0.047) | -0.99(0.046) |
Phase 3 · Liraglutide
NCT01128894 trial results
A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 (Percentage of HbA1c in the blood), Baseline and Week 32. Albiglutide 50 mg: -0.78; Liraglutide 1.8 mg: -0.99.
- Participants
- 841
- Status
- completed
- Completed
- 2011-09
- Sponsor
- GlaxoSmithKline
As posted on ClinicalTrials.gov (NCT01128894), updated at source Feb 23, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT01128894
Percent of participants affected, On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring while participants were on treatment up until 56 days after the last dose (up to.... The most common events the registry lists.
| Event | Albiglutide 50 mg | Liraglutide 1.8 mg |
|---|---|---|
| Any serious event | 5% | 5.6% |
| Nausea | 9.9% | 29.2% |
| Hypoglycaemia | 16.3% | 20.3% |
| Diarrhoea | 14.9% | 13.5% |
| Upper respiratory tract infection | 10.4% | 11% |
| Vomiting | 5% | 9.3% |
| Nasopharyngitis | 5.9% | 6.9% |
| Decreased appetite | 3% | 6.9% |
| Injection site reaction | 6.9% | 1.2% |
| Lipase increased | 5.4% | 6.9% |
| Urinary tract infection | 6.2% | 5.6% |
| Constipation | 4.2% | 6.1% |
| Dyspepsia | 4.2% | 6.1% |
| Headache | 5.4% | 5.4% |
| Dizziness | 2.5% | 5.1% |
| Back pain | 3.7% | 4.7% |
| Arthralgia | 4% | 2.9% |
| Hypertension | 3.2% | 3.7% |
| Gastrooesophageal reflux disease | 2.2% | 3.4% |
| Influenza | 1.7% | 3.2% |
| Fatigue | 3.2% | 2.5% |
| Sinusitis | 3% | 1.7% |
| Cough | 2.5% | 2.9% |
| Abdominal pain upper | 2.7% | 2.5% |
| Abdominal distension | 2.7% | 2% |
| Abdominal pain | 2.5% | 2.7% |
Secondary outcomes
What else it measured
| Measure | Albiglutide 50 mgn=402 | Liraglutide 1.8 mgn=403 |
|---|---|---|
| Week 4, n=387, 392 | -0.52(0.481) | -0.73(0.447) |
| Week 6, n=398, 401 | -0.66(0.566) | -0.94(0.569) |
| Week 12, n=398, 402 | -0.88(0.824) | -1.18(0.798) |
| Week 18, n=398, 402 | -0.87(0.921) | -1.13(0.904) |
| Week 26, n=398, 402 | -0.79(0.968) | -1.00(0.969) |
| Albiglutide 50 mgn=400 | Liraglutide 1.8 mgn=402 |
|---|---|
| -1.22(0.115) | -1.68(0.115) |
| Measure | Albiglutide 50 mgn=402 | Liraglutide 1.8 mgn=403 |
|---|---|---|
| Week 1, n=386, 381 | -0.98(1.939) | -1.62(2.116) |
| Week 2, n= 399, 398 | -1.33(2.194) | -2.25(2.296) |
| Week 3, n= 400, 402 | -1.61(2.067) | -2.43(2.470) |
| Week 4, n= 400, 402 | -1.52(2.148) | -2.45(2.381) |
| Week 6, n= 400, 402 | -1.25(2.317) | -2.11(2.451) |
| Week 12, n= 400, 402 | -1.73(2.526) | -2.10(2.590) |
| Week 18, n= 400, 402 | -1.44(2.362) | -1.74(2.704) |
| Week 26, n= 400, 402 | -1.14(2.694) | -1.64(2.717) |
| Measure | Albiglutide 50 mgn=398 | Liraglutide 1.8 mgn=402 |
|---|---|---|
| HbA1c <6.5% | 78 | 113 |
| HbA1c <7.0% | 168 | 208 |
| Albiglutide 50 mgn=402 | Liraglutide 1.8 mgn=403 |
|---|---|
| NA(NA to NA) | NA(NA to NA) |
| Albiglutide 50 mgn=400 | Liraglutide 1.8 mgn=402 |
|---|---|
| -0.62(3.118) | -2.21(4.147) |
The trial
How NCT01128894 was run
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
- albiglutide: weekly albiglutide subcutaneous injection
- liraglutide: liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Who could join the trial
Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications * BMI \>/=20kg/m2 and \</=45 kg/m2 * Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L) * HbA1c between 7.0% and 10.0%, inclusive * Female subjects of childbearing potential must be practicing adequate contraception. Exclusion Criteria: * History of cancer * History of treated diabetic gastroparesis * Current biliary disease or history of pancreatitis * History of significant GI surgery * Recent clinically significant cardiovascular and/or cerebrovascular disease * Hypertension * History of human immunodeficiency virus infection * History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C * History of alcohol or substance abuse * Female subject is pregnant, lactating, or \<6 weeks postpartum * Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast * History of type 1 diabetes mellitus * Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide) * Receipt of any investigational drug or liraglutide 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 * History or family history of thyroid disease
Published papers
Papers from NCT01128894
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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