Diabetes mellitus type 2 MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM. 2. HbA1c =7.5% and =10.0% at Screening. If the first screening HbA1c does not meet the eligibility criterion, the HbA1c value may be checked up to 2 times during Screening, and if the average of these determinations meets the criterion, the subject can be randomly assigned to treatment. 3. Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following: •Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND •Bolus insulin (at least 2 injections of regular insulin, insulin glulisine, insulin aspart, or insulin lispro) •In addition, the total daily dose of insulin must be =150 units •If taking metformin, a stable dose for at least 8 weeks before Screening Note: Subject should not have received any other antidiabetic medication within 30 days before Screening (e.g., GLP-1R agonist, dipeptidyl peptidase-IV inhibitor, SU, or thiazolidinedione). Subjects receiving commercially available premixed basal and prandial insulin are not eligible for this study. 4. Body mass index =40 kg/m2. 5. Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4 ). 6. Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (as defined below) for the duration of participation in the study including the 4-week Posttreatment Follow-up Period. •Abstinence from penile-vaginal intercourse, when this is the female’s preferred and usual lifestyle •Oral contraceptive, either combined or progestogen alone •Injectable progestogen •Implants of etonogestrel or levonorgestrel •Estrogenic vaginal ring •Percutaneous contraceptive patches •Intrauterine device or intrauterine system that has a failure rate of less than 1% per year when used consistently and correctly as stated in the product label •Male partner sterilization prior to the female subject’s entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnel’s review of subject’s medical records, medical examination of the subject and/or semen analysis, or interview with the subject on his medical history. •Male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository) 7. Willing and able to comply with all study procedures including intensive insulin administration and performance of frequent SMBG profiles according to the protocol. 8. Able and willing to provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1.Type 1 diabetes mellitus 2.History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed) 3. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 4. Current symptomatic biliary disease or history of acute or chronic pancreatitis 5. Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening 6. History of significant GI surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function (e.g., gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function) 7. History of severe hypoglycemia unawareness 8. Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product 9. Clinically significant CV and/or cerebrovascular disease within 3 months before Screening including, but not limited to, the following: •Stroke or transient ischemic attack •Acute coronary syndrome (myocardial infarction [MI] or unstable angina not responsive to nitroglycerin) •Cardiac surgery or percutaneous coronary procedure •Current or history of heart failure (New York Heart Association class III or IV) 10. Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) or bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin 750 mg/dL at Screening. 15. Hemoglobinopathy that may affect proper interpretation of HbA1c. 16. Known allergy to albiglutide or any product components (including yeast and human albumin), any other GLP-1 analogue, insulin, or other study medication’s excipients OR other contraindications (per the prescribing information) for the use of potential study medications (e.g., basal-bolus insulin). 17. Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 we
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of once-weekly albiglutide in providing similar (or better) glycemic control with less hypoglycemia when added to a regimen of intensified basal-bolus insulin therapy compared with intensified basal-bolus insulin therapy alone in subjects with T2DM.;Secondary Objective: To demonstrate a significant difference in body weight between treatment groups To demonstrate a significant reduction in total daily dose of insulin between treatment groups. ;Primary end point(s): - Percentage of subjects with severe or documented symptomatic hypoglycemia through Week 26 (superiority of albiglutide + intensified basal-bolus insulin versus placebo + intensified basal-bolus insulin). - Change from Baseline in HbA1c at Week 26 (noninferiority of albiglutide + intensified basal-bolus insulin versus placebo + intensified basal-bolus insulin).;Timepoint(s) of evaluation of this end point: Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from Baseline in body weight at Week 26 and over time. - Total daily insulin dose at Week 26. ;Timepoint(s) of evaluation of this end point: Week 26 | — |
Countries
Brazil, Canada, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Philippines, Poland, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactAlex H West
GlaxoSmithKline Research & Development Limited
Outcome results
None listed