None listed
Conditions
Interventions
Group 1 Type of group
Albiglutide 30 mg subcutaneous weekly for 52 weeks
Group name:Group 3 Type of group
Placebo similar to subcutaneous albiglutide weekly for 52 weeks
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Man or woman, 18 years of age or older, with a historical diagnosis of type 2 diabetes mellitus who is experiencing inadequate glycemic control and is not receiving current antidiabetic therapy. The subject must not have received> 7 days in a row from any antidiabetic agent within 3 months before the Selection • Failed treatment with diet and exercise for at least 1 month before randomization • The diagnosis of type 2 diabetes should be based on the current criteria of the American Diabetes Association • BMI> 20 kg / m2 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, they should be in a stable dose for at least 4 weeks before Selection. However, USE is permitted as necessary of medications that require a prescription or are available without a doctor´s prescription at the discretion of the investigator. • The use of systemic oral or injectable glucocorticoids is not allowed within 3 months before randomization. Inhaled, intra-articular and topical corticosteroids are allowed. • Hemoglobin> 11 g / dL (> I 10 g / L) for male subjects and> 10 g / dL (> 100 g / L) for female subjects • Creatinine clearance> 60 mL / min • The level of thyroid stimulating hormone is normal or clinically euthyroid at the investigator´s discretion • Female subjects with reproductive potential (that is, who are not surgically sterile and / or postmenopausal) should be practicing adequate contraception. Suitable methods of contraception 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 admission of the female subject and if the male partner is the only couple of the subject, double barrier method (condom or diaphragm plus • Nonoxynol-9), or oral contraceptives in combination with a second method of contraception (eg, condom or diaphragm). Proper contraception should be practiced for the duration of participation in the study including the 8 week Post Treatment Follow-up Period • Able and willing to monitor your own blood glucose concentrations with a glucose monitor at home • Without major illnesses or weaknesses that in the opinion of the researcher prohibit the subject from completing the study. • Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: • History of cancer, other than squamous cell or basal cell carcinoma of the skin, which is not in complete remission for at least 3 years before Selection (A history of cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia 11 treated is allowed) • History of treated diabetic gastroparesis • Symptomatic ongoing biliary disease 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 • Clinically significant cardiovascular and / or cerebrovascular disease • 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 previous known history of Gilbert´s syndrome and a fractionated bilirubin showing conjugated bilirubin 2.5 x ULN. • Fasting triglyceride level> 850 mg / dL. If the subject´s triglyceride level is> 850 mg / dL 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 before Selection) with hepatitis B; however, subjects with old or chronic hepatitis B or hepatitis C are allowed as long as the requirements for 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 within 1 year before the Selection • Positive results in the urine drug review in the National Team • The female subject is pregnant (confirmed by laboratory tests), nursing or <6 weeks postpartum • Known allergy to any excipient of the albiglutide formulation, history of drug allergy or other allergy (including yeast allergy) or sensitivity to any GLP-I analogue • Receipt of any investigational drug within 30 days or 5 half-lives, whichever is longer, before Selection, history of reception of an antidiabetic drug within 3 months before randomization or reception of albiglutide in previous studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Glycated hemoglobin (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 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. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. 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. 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
Mexico, Peru, South Africa, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed