None listed
Conditions
Interventions
Group 1 Type of group
Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
Group name:Group 2 Type of group
albiglutide 30 mg weekly injection + pioglitazone (with or without meformin)
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Man or woman, 18 years of age or older, with a historical diagnosis of type 2 diabetes mellitus who is currently taking pioglitazone treatment (with or without metformin), but who is experiencing inadequate glycemic control. The subject must have received pioglitazone (with or without metformin) at least during the 3 months prior to the Evaluation for Selection; and stable doses at least during the 8 weeks prior to randomization. Subjects receiving pioglitazone as part of their antidiabetic therapy should be taking a minimum stable dose of 30 mg daily, unless there is documentation that a lower dose (i.e. 15 mg) is the subject´s DMT. Subjects receiving metformin should be taking a stable dose> 1500 mg of metformin LI. Subjects with a documented DMT 7 consecutive days of any antidiabetic agent other than pioglitazone (with or without metformin) within 3 months prior to the Selection Evaluation. • BMI> 20kg / m2 and 0.8 ng / mL (> 0.26 nmol / L) • HbA1c between 7.0% and 10.0%, inclusive • If regular use of other non-excluded medications is used, they should be taken at stable doses at least 4 weeks before the Selection Evaluation. However, the use of prescribed and non-prescription medications is allowed, as necessary, in the opinion of the investigator. • The use of oral or systemically injected glucocorticoids is not allowed within 3 months prior to randomization. The use of inhaled, intra-articular and topical colicosteroids is allowed. • Hemoglobin> 11 g / dL (> 1I0 g / L) for male subjects and 2:10 g / dL (> 100 g / L) for female subjects • Creatinine clearance> 60 mL / min (calculated using the Cockcroft-Gault formula) • The level of thyroid stimulating hormone is normal or clinically euthyroid at the investigator´s discretion • Female subjects with the potential to get pregnant (ie, without surgical sterilization and / or who are not postmenopausal) should use an appropriate contraceptive method. Suitable contraceptive methods include the following: abstinence, injectable progestogens, levonorgestrel implants, estrogen vaginal ring, percutaneous contraceptive patches, intrauterine device or intrauterine system, sterilization of the male partner (vasectomy with azoospermia documentation) before sex subjects Females enter the study and have this male partner be the only partner of the subject, double barrier method (condom or occlusive cap plus nonoxin I-9), or oral contraceptives in combination with a second contraceptive method (for example: condom or occlusive cap) . Proper contraception should be practiced during all study participation, including the 8-week Post-Treatment Follow-up Period. • Able and willing to monitor your blood glucose concentrations with a homemade glucose monitor • Without major illnesses or weaknesses that in the opinion of the researcher prevent the subject from completing the study • Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: • History of cancer, except squamous cell carcinoma or basal skin cells, that has not been in full remission at least 3 years before the Screening Evaluation. (History of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed) • History of treated diabetic gastroparesis • Current ongoing symptomatic biliary disease or history of pancreatitis • History of significant gastrointestinal surgery, including gastric bypass and band, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection or surgeries considered to significantly affect upper gastrointestinal function • Clinically significant recent cardiovascular and / or cerebrovascular disease • Hemoglobinopathy that could affect the determination of HbA1c • History of human immunodeficiency virus infection • History of total bilirubin> 1.5 x e! upper limit of normal (ULN), except that the subject has a known history of Gilbert´s syndrome and a fractional bilirubin that shows conjugated bilirubin 2.5 x ULN • Fasting triglyceride level> 850 mg / dL. If the subject´s triglyceride level is> 850 mg / dL in the Evaluation for Selection, the subject may be delayed and reevaluated. Treated subjects must be taking a stable dose of medication at least 4 weeks before being reevaluated. • Acute infection (within 3 months prior to Evaluation for Selection) with hepatitis B; however, subjects with a history of hepatitis B or chronic hepatitis B or hepatitis C are allowed provided that the requirements for ALT, AST and total bilirubin are met • History of a psychiatric disorder that could affect the subject´s ability to participate in the study • History of alcohol or substance abuse 1 year before the Selection Evaluation • Positive urine doping test result • Female subjects who are pregnant (confirmed by laboratory test), breastfeeding or <6 weeks postpartum • Known allergy to any of the excipients of the formulation for albiglutide, history of drug allergy or other allergies (including yeast allergy), or sensitivity to any GLP-1 analog • Reception of any investigational medication 30 days or 5 half-lives, whichever is longer, prior to the Evaluation for Selection, history of reception of an antidiabetic drug in Invention 3 months before randomization or reception of albiglutide in previous studies
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 + current antidiabetic therapy. 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. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis. 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. 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 Weeks 104 and 156 Timepoints:Baseline and Weeks 104 and 156 ; Outcome name:Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and =250 mg/dL between >=Week 4 and =8.5% and a =Week 12 and =8.5% between >=Week 24 and =8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. Measure:Time to Hyperglycemia Rescue Timepoints:From the start of study medication until the end of the treatment (up to 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 a | — |
Countries
Argentina, Brazil, China, Czech Republic, France, Germany, India, Korea South, Mexico, Peru, Philippines, Russian Federation, South Africa, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed