Type 2 Diabetes Mellitus With Renal Impairment MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
GlaxoSmithKline LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 years of age or older, who is 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 =45 kg/m2 3. Fasting C-peptide =0.8 ng/mL (=0.26 nmol/L) 4. HbA1c between 7.0% and 10.0%, inclusive, at Visit 5 (Week –1). The HbA1c value may be checked up to 4 times, and if the average of these determinations meets the criterion, the subject may be randomly assigned to treatment 5. For the regular use of other medications (does not include medications excluded by the protocol, it is preferred that the subjects are receiving a stable dose for at least 4 weeks before Screening; however, as necessary during the Run-in/Stabilization Period and the Treatment Period, prescription or over-the-counter medications are allowed and may be adjusted by the investigator to optimize treatment 6. Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; however, short courses of oral steroids (single dose or multiple doses for up to 2 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra-articular, and topical corticosteroids are allowed 7. Hemoglobin =10 g/dL (=100 g/L) for male subjects and =9 g/dL (=90 g/L) for female subjects 8. GFR =15 mL/min and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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) 2. History of treated diabetic gastroparesis 3. Current ongoing symptomatic biliary disease or history of pancreatitis 4. History of significant gastrointestinal surgery, including gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper gastrointestinal function 5. Recent clinically significant cardiovascular and/or cerebrovascular disease 6. Hemoglobinopathy that may affect determination of HbA1c 7. History of human immunodeficiency virus infection 8. History of total bilirubin >1.5 × ULN unless the subject has a previously known history of Gilbert’s syndrome and a fractionated bilirubin that shows conjugated bilirubin 2.5 ×ULN3 10. Fasting triglyceride level >850 mg/dL at Screening or Visit 5 (Week –1). If the subject’s triglyceride level is >500 mg/dL at Screening and Visit 5 (Week –1), the subject is excluded. If the subject meets the aforementioned exclusion criteria for triglycerides, the subject can be treated and rescreened. Treated subjects must be on a stable dose of medication for at least 4 weeks before being rescreened 11. Acute symptomatic (within 3 months before Screening) infection with hepatitis B or hepatitis C; however, subjects with past or chronic hepatitis B or hepatitis C are allowed provided the requirements for ALT, AST, and total bilirubin are met 12. History of a psychiatric disorder that will affect the subject’s ability to participate in the study 13. History of alcohol or substance abuse within 1 year before Screening 14. Positive urine drug screen at Screening, unless the subject is taking a medically approved medication for which a positive drug screen simply verifies the use of this medication 15. Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum 16. Known allergy to any GLP-1 analogue, sitagliptin, other study medications’ excipients, excipients of albiglutide, or Baker’s yeast 17. History of type 1 diabetes mellitus, diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) that in the opinion of the investigator would preclude effective participation in the study, or a history of ketoacidosis or hyperosmolar coma 18. Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., sitagliptin) 19. 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 20. History or family history of medullary carcinoma 21. History or family history of multiple endocrine neoplasia type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of albiglutide as compared with sitagliptin on the HbA1c change from Baseline at Week 26.;Secondary Objective: Secondary efficacy objectives at time points to be specified in the statistical analysis plan (SAP) include the following evaluations of treatment with albiglutide as compared with sitagliptin: • HbA1c change from Baseline over time • Fasting plasma glucose (FPG) change from Baseline over time • Proportion of subjects at a HbA1c treatment goal of <7.0% • Proportion of subjects at a HbA1c treatment goal of <6.5% • Time to hyperglycemia rescue • Change from Baseline in body weight • Population PK of albiglutide and the effect of plasma concentrations of albiglutide on glycemic control (population PK/PD);Primary end point(s): The primary efficacy analysis endpoint will be HbA1c change from Baseline after 26 weeks of treatment. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed