Phase 2
Completed N=212
Dose Ranging Study of Albiglutide in Japanese Subjects
Source: ClinicalTrials.gov NCT01098461 ↗Enrolled (actual)
212
Serious AEs
3.3%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 — 0.28; -0.61; -1.27; -0.82 Percentage of HbA1c in the blood — p=<0.0001
Summary
This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 |
0.28; -0.61; -1.27; -0.82 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16 |
0.03; -0.33; -0.61; -0.36; 0.20; -0.59 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16 |
0.30; -1.54; -2.27; -1.32; 0.41; -1.54 | — |
| SECONDARY Change From Baseline in Body Weight at Week 4, 8, 12, and 16 |
-0.16; -0.36; -0.25; -0.02; -0.29; -0.06 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16 |
0; 1; 2; 1; 0; 5 | — |
| SECONDARY Mean Clearance of Albiglutide |
47.8 | — |
| SECONDARY Mean Volume of Distribution of Albiglutide |
9.34 | — |
| SECONDARY Mean Absorption Rate of Albiglutide |
0.0154 | — |
| SECONDARY Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG |
3360; 3850 | — |
Eligibility Criteria
Inclusion Criteria
- Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD
- BMI ≥18 kg/m2 and 160 mm Hg or diastolic pressure >95 mm Hg at Screening
- ECG criteria at Screening
- Heart rate: 110 bpm
- PR interval: 210 msec
- QRS interval: 120 msec
- QTc interval (Bazett): >450 msec or >480 msec with bundle branch block
- Fasting triglyceride level >400 mg/dL at Screening
- AST or ALT >2xULN, ALP and bilirubin >1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin ULN
- Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
- Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening
- Current and history of alcohol or substance abuse
- Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant
- Prior use of a GLP-1 analog
- Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation
- History of or family history of medullary carcinoma of the thyroid.
- History of or family history of multiple endocrine neoplasia type 2
- Receipt of any investigational drug within the 12 weeks before Screening
Data sourced from ClinicalTrials.gov (NCT01098461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.