None listed
Conditions
Interventions
Group 1 Type of group
Albiglutide 30 mg + Metformin> 1500 mg for 156 weeks.
Group name:Group 4 Type of group
Metformin> 1500 mg + Placebo of the three medications for 156 weeks.
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female, 18 years of age or older, with a historical diagnosis of type 2 diabetes mellitus who is currently treated with metformin but who is experiencing inadequate glycemic control. The subject should have received metformin for at least 3 months before Screening; and the subject must have a stable dose of =1500 mg metformin for at least 8 weeks before randomization. Subjects with a documented MTD of 7 contiguous days of any antidiabetic agents other than metformin within the 3 months before Screening • BMI =20 kg/m2 and =45 kg/m2 • Fasting C-peptide =0.8 ng/mL (=0.26 nmol/L) • 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 • For the regular use of other medications (does not include medications excluded by the protocol [see Section 5.6.2, for example, weight loss medications are excluded]), it is preferred that subjects be on 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 (e.g., increase or decrease of medication to treat blood pressure or hyperlipidemia in accordance with accepted local medical practice and relevant guidance documents) • Use of oral or systemically injected glucocorticoids is generally not allowed within the 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 • Hemoglobin =11 g/dL (=110 g/L) for male subjects and =10 g/dL (=100 g/L) for female subjects • Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula) • Thyroid-stimulating hormone level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., T4, T3, thyroid-binding globulin) • Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. Methods of adequate contraception include the following: abstinence, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device or intrauterine system, male partner sterilization (vasectomy with documentation of azoospermia) before the female subjects entry into the study and this male partner is the sole partner for that subject, double-barrier method (condom and occlusive cap plus nonoxynol-9), or oral contraceptives in combination with a second method of contraception (e.g., condom and occlusive cap). Adequate contraception must be practiced for the duration of participation in the study including the 8-week Posttreatment Follow-up Period • Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor • No major illness or debility that in the investigator’s opinion prohibits the subject from completing the study
Exclusion criteria
Exclusion criteria: • 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) • History of treated diabetic gastroparesis • Current ongoing symptomatic biliary disease or history of pancreatitis • 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 • Recent (as defined below) clinically significant cardiovascular and/or cerebrovascular disease including, but not limited to, the following: •Previous history of stroke or transient ischemic attack within 1 month before Screening. However, subjects who are deemed clinically stable by the investigator may be enrolled 1 month after the cerebrovascular event •Acute coronary syndrome, which includes the following: •Documented MI within the 2 months before Screening and during the period up until receiving the first dose of study medication •Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within the 2 months before Screening and during the period up until receiving the first dose of study medication •Unstable angina not responsive to nitroglycerin within the 2 months before Screening and during the period up until receiving the first dose of study medication •Unstable cardiac rhythm; however, as an example, controlled atrial fibrillation is allowed •Current or history of heart failure (New York Heart Association class III to IV) •Resting systolic pressure is >160 mm Hg and/or diastolic pressure >100 mm Hg. If the subject’s systolic blood pressure >160 mm Hg or the subject’s diastolic blood pressure is >100 mm Hg at Screening, the blood pressure reading may be repeated at 5-minute intervals for a total of 3 determinations. If the average of the systolic or diastolic pressure readings still does not meet the criteria, the subject can be treated and rescreened. It is preferred that subjects be on a stable dose of medication for at least 4 weeks before being rescreened; however, when stable, they may be rescreened at the discretion of the investigator. Should a subject not meet this criterion on Visit 6 (first dose of study medication following the randomization visit), the subject may continue in the study at the discretion of the investigator with the understanding that the subject’s hypertension will be monitored and treated in accordance with accepted local medical practice and relevant guidance documents •Mean QTc interval (Fridericia) >470 ms confirmed by a central reader at Screening • Hemoglobinopathy that may affect determination of HbA1c • History of human immunodeficiency virus infection • 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 × ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Hematology and chemistry evaluations will be carried out in Visits 1 (Selection), 5 (Week -1), 6 (baseline evaluation), 7 to 25 (Weeks I to 156), and 26 (Week 164, Follow-up). Measure:Variation of HbA1c in Week 104 Timepoints:Week 104 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Hematology and chemistry evaluations will be carried out in Visits 1 (Selection), 5 (Week -1), 6 (baseline evaluation), 7 to 25 (Weeks I to 156), and 26 (Week 164, Follow-up). Measure:HbA1c variation over time Timepoints:During the study ; Outcome name:Hematology and chemistry evaluations will be carried out in Visits 1 (Selection), 5 (Week -1), 6 (baseline evaluation), 7 to 25 (Weeks I to 156), and 26 (Week 164, Follow-up). Measure:Time to rescue hyperglycemia Timepoints:During the study ; Outcome name:A complete physical exam will be performed on Visits 1 (Selection), 17 (Week 52), 21 (Week 104), and on the end of treatment visit (Week 156). Measure:Body Weight Variation Timepoints:During the studio ; Outcome name:Hematology and chemistry evaluations will be carried out in Visits 1 (Selection), 5 (Week -1), 6 (baseline evaluation), 7 to 25 (Weeks I to 156), and 26 (Week 164, Follow-up). Measure:Variation in biomarker data (CRP, adiponectin, leptin and detailed lipid profile) Timepoints:During the study | — |
Countries
Germany, Peru, Spain, United Kindgdom
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed