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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

Key facts

Study ID

NCT00976391

Run by

GlaxoSmithKline

People needed

586

Starts

2009-09-01

Expected to finish

2012-05-01

Last updated by the study team

2017-01-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Dothan, Alabama, United States
• GSK Investigational Site — Gilbert, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Searcy, Arkansas, United States
• GSK Investigational Site — Chino, California, United States
• GSK Investigational Site — Commerce, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Fullerton, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Alamitos, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Satna Monica, California, United States
• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Tustin, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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