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Keep this study
Lead
GlaxoSmithKline
With
PPD Development, LP
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM
HbA1c \>= 7.0% and \<= 9.0% at Screening.
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) with a total daily dose of bolus insulin \<= 70 units
In addition, the total daily dose of insulin must be \<= 140 units
You may not be if
Fasting C-peptide \>= 0.8 nanogram (ng) per milliliter (mL) \[\>= 0.26 nanomoles per litre (nmol/L)\]
Body mass index \<= 40 kilogram per square meter( kg/m\^2)
Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4)
Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (as defined in the protocol) for the duration of participation in the study including the 4-week post treatment Follow-up Period..
Willing and able to comply with all study procedures including performance of frequent self-monitored blood glucose (SMBG) profiles according to the protocol
Able and willing to provide written informed consent
Type 1 diabetes mellitus
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)
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Current symptomatic biliary disease or history of acute or chronic pancreatitis
Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening
History of significant GI surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function \[e.g., gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function\]
History of severe hypoglycemia unawareness
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
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)
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 \<35%)
Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and is not on active antiviral treatment \[e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of Screening\])
Hemoglobin \<11 gram (g) per (dL) \[\<110 g/L\] for male subjects and \<10 g/dL (\<100 g/L) for female subjects at Screening
Estimated glomerular filtration rate (eGFR) \<= 30 millilitre per minute per 1.73 square meters (mL/min/1.73 m\^2) (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula) at Screening Note: As the use of metformin in subjects with varying degrees of renal function may differ from country to country, use of metformin should be in accordance with the metformin product label within the participating country.
Fasting triglyceride level \>750 mg/dL at Screening
Hemoglobinopathy that may affect proper interpretation of HbA1c
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., insulin glargine, insulin lispro)
Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (\>1 week) in the 6 months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed
Female subject is pregnant (confirmed by laboratory testing) or lactating
Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies
Clareo Health | Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
