None listed
Conditions
Interventions
Group 1 Type of group
Albiglutide 30 mg weekly (with a dosage increase of 50 mg per week if necessary)
Group name:Group 2 Type of group
Insulin glargine (dosage titration for prescribing information / insert)
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Men or women, 18 years of age or older, with a previous diagnosis of type 2 diabetes mellitus currently treated with metformin alone or with metformin + sulfonylurea, but who show insufficient glycemic control. The subject must have received their current antidiabetic medication for at least 3 months before selection and be taking a stable dose from at least 8 weeks before randomization. The subject must have maintained a stable dose of IR metformin> or = 1500 mg for at least 8 weeks before randomization. Subjects receiving a documented DMT or = 20 and or = 0.8 ng / ml (> or = 0.26 nmol / l). • HbA1c between 7.0% and 10.0%, both inclusive. • In case of regular use of other drugs not excluded, the dose must have been stable for at least four weeks prior to selection. However, on-demand use of prescription or over-the-counter medications at the discretion of the investigator will be allowed. • The use of oral or systemically injected glucocorticoids during the three months prior to randomization will not be allowed. The use of inhaled, intra-articular and topical corticosteroids will be allowed. • Hemoglobin> or = 11 g / dl (> or = 110 g / l) in men and> or = 10 g / dl (> or = 100 g / l) in women. • Creatinine clearance> 60 ml / min (calculated with the Cockcroft-Gault formula). • Normal thyrotropin concentration or clinical euthyroidism according to the investigator´s criteria. • Women of childbearing age (ie, who are not surgically sterile or postmenopausal) should be using appropriate contraceptive methods. Suitable contraceptive methods are: abstinence, injectable progestogen, levonorgestrel implants, estrogen vaginal ring, percutaneous contraceptive patches, intrauterine device or system, sterilization of the male partner (vasectomy with azoospermia documentation) before a woman enters the study, said male partner being that woman´s only partner, double barrier method (condom or occlusive cap plus nonoxynol-9) or oral contraceptives in combination with a second contraceptive method (e.g., condom or occlusive cap). Proper contraception should be practiced during the entire participation in the study, including the follow-up period after the eight-week treatment. • Ability to monitor blood glucose concentration with a household glucometer and willingness to do so. • No major illness or weakness that, in the opinion of the researcher, prevents the subject from completing the study. • Ability to grant written informed consent and willingness to do so.
Exclusion criteria
Exclusion criteria: • History of cancer, other than spinocellular or basal cell carcinoma of the skin, that has not been in complete remission for at least three years before selection. (The history of treated cervical intraepithelial neoplasia I or II will be allowed). • History of treated diabetic gastroparesis. • Symptomatic ongoing biliary disease or a history of pancreatitis. • History of major gastrointestinal surgery, such as gastric bypass and elastic band placement, antrectomy, Roux Y-shunt, gastric vagotomy, small bowel resection or interventions that are thought to significantly affect upper gastrointestinal function. • Recent cardiovascular or cerebrovascular diseases with clinical importance • Hemoglobinopathy that may affect the determination of HbA1c. • History of infection by the human immunodeficiency virus. • History of total bilirubin> 1.5 times the upper limit of normal (LSN), unless the subject has a known history of Gilbert´s syndrome and a fractional bilirubin that reveals a conjugated bilirubin 2.5 times the LSN. • Fasting triglyceride concentration> 850 mg / dl. If the subject´s triglyceride concentration is> 850 mg / dL at the time of selection, it may be treated and undergo a new selection. Treated subjects should receive a stable dose of medication for at least four weeks before undergoing a new selection. • Acute infection (during the three months prior to selection) by hepatitis B virus; however, the participation of subjects with past or chronic hepatitis B or C will be allowed provided that the requirements of ALT, AST and bilirubin are met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Hematology and chemistry evaluations will be carried out in Visits 1 (Selection), 5 (Week-1), 6 (Basal), 7ala 10 (Weeks 1 to 8), 12 to 15 (Weeks 12 to 24), and 17 to 27 (Weeks 36 to 156), and 28 (Follow-up). Measure:Variation of HbA1c between baseline and week 52 Timepoints:Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Hematology and chemistry evaluations will be carried out in Visits 1 (Selection), 5 (Week-1), 6 (Basal), 7ala 10 (Weeks 1 to 8), 12 to 15 (Weeks 12 to 24), and 17 to 27 (Weeks 36 to 156), and 28 (Follow-up). Measure:Variation of HbA1c with respect to baseline over time. Timepoints:During the study ; Outcome name:Hematology and chemistry evaluations will be carried out in Visits 1 (Selection), 5 (Week-1), 6 (Basal), 7ala 10 (Weeks 1 to 8), 12 to 15 (Weeks 12 to 24), and 17 to 27 (Weeks 36 to 156), and 28 (Follow-up). Measure:Variation of other glycemic control measures, including GA, time to rescue of hyperglycemia and incidence of clinically significant levels of HbA1c response Timepoints:During the study ; Outcome name:A complete physical examination and weight measurement will be performed on Visits 1 (Selection), 19 (Week 52), 23 week 104), and 27 (End of Treatment, Week 156). Measure:Variations in body weight with respect to baseline Timepoints:During the study | — |
Countries
Peru, Spain, United Kindgdom
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed