None listed
Conditions
Interventions
Arm 1 (Experimental): albiglutide
Intervention: Drug: albiglutida 30 mg weekly subcutaneous injection + sitagliptin matching placebo
Arm (Active Comparator): sitagliptin
albiglutide ma
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 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 2. •BMI >/=20 kg/m2 and /=0.8 ng/mL (>/=0.26 nmol/L) 4. •HbA1c between 7.0% and 10.0%, inclusive. Other protocol-defined inclusion criteria apply.
Exclusion criteria
Exclusion criteria: 1. History of cancer 2. History of treated diabetic gastroparesis 3. Current biliary disease or history of pancreatitis 4. History of significant gastrointestinal surgery 5. Recent clinically significant cardiovascular and/or cerebrovascular disease 6. History of human immunodeficiency virus infection 7. Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C 8. Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum 9. Known allergy to any GLP 1 analogue, sitagliptin, other study medications´ excipients, excipients of albiglutide, or Baker´s yeast 10. 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 Other protocol-defined exclusion criteria apply.
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed