None listed
Conditions
Interventions
Grupo 2 Type of group
albiglutide weekly subcutaneous injection + metformin + glimepiride + pioglitazone matching placebo
Group name:Group 3 Type of group
albiglutide matching placebo weekly subcutaneous injection + metformin + glimepiride + pioglitazone matching placebo
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Be male or female, 18 years of age or older, with a historical diagnosis of type 2 diabetes mellitus who is being treated with IR metformin and sulfonylurea but is experiencing inadequate glycemic control. The subject should be receiving at least 1500 mg daily of metformin IR and a dose of sulfonylurea equivalent to 4 mg of glimepiride for at least 3 months before Selection; and a stable dose of each of them for at least 8 weeks before randomization. The SPM / ISFN provides additional information on the equivalent dose of sulfonylurea. Subjects with 7 continuous days any antidiabetic agent other than metformin and a sulfonylurea within 3 months prior to the Selection. • BMI> 20 kg / m ^ 2 and 0.8 ng / mL (> 0.26 nmol / L) • HbA1c between 7.0% and 10.0%, inclusive • If there is regular use of other non-excluded medications, you must be taking a stable dose for at least 4 weeks before Selection. Without embedding, the use of medications that require a prescription or are available on a shelf is allowed at the Investigator´s Judgment. • The use of oral or systematically injected glucocorticoids is not allowed within 3 months prior to randomization. The use of inhaled, intra-articular and topical corticosteroids is allowed. • Hemoglobin> 11 g / dL (> 110 g / L) for male subjects and> 10 g / dl (> 100 g / L) for female subjects • Creatinine removal> 60 ml / min (calculated using the Cockcroft-Gault formula) • The level of thyroid stimulating hormone is normal or clinically eutiroldeo in the opinion of the Investigator • Female subjects with reproductive potential (ie, who are not surgically sterile and / or postmenopausal) should be using some appropriate contraceptive method. Suitable contraceptive methods include the following: withdrawal, injectable progestogen, levonorgestrel implants, estrogen vaginal ring, percutaneous contraceptive patches, intrauterine device or intrauterine system, sterilization of the male partner (vasectomy with documented azoospermia) before the female subject enters to participate in the study and if the male partner is the only partner of the subject, double barrier method (condom or occlusive cap plus nonoxynol-S), or oral contraceptives in combination with a second contraceptive method (i.e. condom or occlusive cap). Proper contraception should be practiced for the duration of your participation in the study including the 8-week Post-Treatment Follow-up Period. • Able and willing to monitor their own blood glucose concentrations with a glucose monitor at home • Not be affected by any illness or weakness Important that in the Investigator´s opinion prevents the subject from completing the study • Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: • History of cancer, except squamous cell or basal cell carcinoma of the skin, which is not in complete remission for at least 3 years before Selection (Allowed if you have had a history of cervical intraepithelial neoplasia I or intraepithelial neoplasia cervical II) • History of treated diabetic gastroparesis • Symptomatic biliary disease in progress, current or history of pancreatitis • History of significant gastrointestinal surgery, including gastric and bandaged bypass, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection or surgeries that are considered to significantly affect gastrointestinal function • Recent clinically significant cardiovascular and / or cerebrovascular disease (as defined below) • Hemoglobinopathy that may affect the determination of HbA1c • History of infection with human immunodeficiency virus • History of total bilirubin> 1.5 x the upper limit of normal (ULN) unless the subject has a known history of Gilbert´s syndrome and a fractional bilirubin showing conjugated bilirubin 2.5 x ULN • Fasting triglyceride level> 850 mg / dL. If the subject´s triglyceride level is> 850 mg / di in the Selection, the subject can be treated and re-selected. Treated subjects must be on a stable dose of medication for at least 4 weeks before being re-selected. • Acute infection (within 3 months prior to Selection) with hepatitis B; however, subjects with hepatitis B or past or chronic hepatitis C may participate provided that the requirements of ALT, AST and total bilirubin are met • History of psychiatric disorder that will affect the subject´s ability to participate in the study • History of alcohol or substance abuse during the term of 1 year before the Selection • Positive drug results in the urine test during Selection • Ignorance of hypoglycemia with autonomic dysfunction • The female subject is pregnant (confirmed by laboratory tests), nursing or <6 weeks postpartum • Known allergy to any excipient of the formulation of albiglutide, sitaliptin or pioglitazone, a history of drug allergy or other allergy (including yeast allergy) or sensitivity to any GLP-1 analog • Having received any investigational drug within 30 days or 5 half-lives, whichever is longer, before the Selection, a history of having received an antidiabetic drug during the 3 months prior to randomization or use of albiglutide in studies previous
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint. Measure:Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 Timepoints:Baseline and Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. Measure:Change From Baseline in HbA1c at Week 104 and Week 156 Timepoints:Baseline, Week 104, and Week 156 ; Outcome name:The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region. Measure:Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 Timepoints:Baseline and Week 52 ; Outcome name:The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. Measure:Change From Baseline in FPG at Week 104 and Week 156 Timepoints:Baseline, Week 104, and Week 156 ; Outcome name:Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hypergl | — |
Countries
Argentina, Brazil, China, Czech Republic, France, Germany, India, Korea South, Mexico, Peru, Philippines, Russian Federation, South Africa, Spain, Taiwan, United Kindgdom, United States
Outcome results
None listed