OT AVAILABLE
- Registration Number
- PER-047-10
- Lead Sponsor
- GlaxoSmithKline,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 36
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 3.•Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
4.•HbA1c between 7.0% and 10.0%, inclusive.
Other protocol-defined inclusion criteria apply.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method