Phase 3
Completed N=495
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
Source: ClinicalTrials.gov NCT01098539 ↗Enrolled (actual)
495
Serious AEs
12.7%
Results posted
May 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 — -0.83; -0.52 Percentage of HbA1c in the blood — p=<0.0001
Summary
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 |
-0.83; -0.52 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF |
-0.43; -0.37; -0.60; -0.52; -0.69; -0.56 | — |
| SECONDARY Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases |
-0.43; -0.37; -0.63; -0.56; -0.71; -0.62 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-1.42; -0.22 | — |
| SECONDARY Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF |
-1.47; -0.84; -1.19; -0.82; -1.35; -0.81 | — |
| SECONDARY 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 |
-0.82; -0.93; -1.28; -0.66; -1.25; -0.88 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF |
37; 29; 103; 72 | — |
| SECONDARY 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 |
102; 77; 49; 38; 26; 17 | — |
| SECONDARY Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC |
44; 27; 98; 61 | — |
| SECONDARY 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 |
79; 65; 43; 30; 20; 15 | — |
| SECONDARY Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 |
0; 2; 0; 2; 1; 3 | — |
| SECONDARY Time to Hyperglycemic Rescue Through Week 52 |
NA; NA | — |
| SECONDARY Change From Baseline in Body Weight at Week 26: LOCF |
-0.79; -0.19 | — |
| SECONDARY Change From Baseline in Body Weight Through Week 26: LOCF |
-0.17; 0.12; -0.21; -0.02; -0.25; 0.01 | — |
| SECONDARY Change From Baseline in Body Weight Through Week 52: OC |
-0.17; 0.12; -0.21; -0.01; -0.24; 0.03 | — |
| SECONDARY Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 |
3005.80; 3452.62; 2994.15; 3583.06 | — |
Eligibility Criteria
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 /=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
Data sourced from ClinicalTrials.gov (NCT01098539). 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.