A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine | NCT00976391 | Trialant

A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine | NCT00976391 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Subjects with type 2 diabetes, currently treated with insulin glargine or other intermediate- or long-acting insulin, with or without oral antidiabetic medications, but experiencing inadequate glycemic control and willing and capable of participating in a regimen of intensive insulin administration. A subject who has been on an intermediate- or long acting insulin for >/=6 months but <5 years, and, in spite of dosage adjustments based on home blood glucose monitoring, is unable to achieve a HbA1c of <7%.

BMI >/= 20kg/m2 and </=45 kg/m2

Fasting C-peptide >/=0.8 ng/mL (>/= 0.26 nmol/L)

HbA1c between 7.0% and 10.5%, inclusive

Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; inhaled, intra articular, and topical corticosteroids are allowed

Hemoglobin </=11 g/dL for male subjects and >/=10 g/dL 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. 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 as per the protocol recommendations of self administration

No major illness or debility that in the investigator's opinion prohibits the subject from actively participating in their diabetes management and completing the study

Able and willing to provide written informed consent

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.

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 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.

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 I to IV).

Resting systolic pressure is >160 mm Hg and/or diastolic pressure >100 mm Hg.

QTc interval (Fridericia) >470 ms confirmed by a central reader at Screening

History of stroke or other central nervous system disorder that would negatively impact the subject's ability to participate in a program of intensive insulin management (eg, physically or mentally incapable of performing home blood glucose monitoring or administering and/or adjusting insulin dosage)

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 <35% of total bilirubin

ALT or aspartate aminotransferase (AST) >2.5 ×ULN

Fasting triglyceride level >850 mg/dL at Screening or Week -1 (Visit 5).

Acute symptomatic (within 3 months before Screening) infection with hepatitis B or hepatitis C; however, subjects with past or chronic hepatitis B or hepatitis C are allowed provided the requirements for ALT, AST, and total bilirubin are met

History of a psychiatric disorder that will affect the subject's ability to participate in the study

History of alcohol or substance abuse within 1 year before Screening

Positive urine drug screen at Screening, unless the subject is taking a medically approved medication for which a positive drug screen simply verifies the use of this medication

Hypoglycemia unawareness which has impaired cognitive function and required outside assistance

Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum

Known allergy to any GLP 1 analogue, insulin, other study medications' excipients, excipients of albiglutide, or Baker's yeast

Receipt of any investigational drug within the 30 days, or 5 half lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies

Current use of any GLP 1 analogue

History of type 1 diabetes mellitus, diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) that in the opinion of the investigator would preclude effective participation in the study, or a history of ketoacidosis or hyperosmolar coma

Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., insulin glargine or lispro insulin)

History or family history of medullary carcinoma

History or family history of multiple endocrine neoplasia type 2