A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine.
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2
- Registration Number
- CTRI/2010/091/000071
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Subjects eligible for enrollment in the study must meet all of the following criteria:
1.Male or female, 18 to 75 years of age, inclusive, with a historical diagnosis of type 2 diabetes mellitus who is currently treated with insulin glargine, or other intermediate- or long-acting insulin, with or without oral antidiabetic medications but who is experiencing inadequate glycemic control and who is 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%. These subjects must be capable and willing to transition from a simple basal insulin regimen to an intensified regimen
2.BMI ≥20kg/m2 and ≤45 kg/m2
3.Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
4.HbA1c between 7.0% and 10.5%, 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
5.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 the subjects are receiving a stable dose for at least 4 weeks before Screening; however, as necessary during the Run-in 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)
6.Use of oral or systemically injected glucocorticoids is generally not allowed within 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
7.Hemoglobin ≥11 g/dL (≥110 g/L) for male subjects and ≥10 g/dL (≥100 g/L) for female subjects
8.Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula)
9.Thyroid-stimulating hormone level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., T4, T3, thyroid-binding globulin)
10.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 subject?s 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
11.Able and willing to monitor his or her own blood glucose co
Subjects meeting any of the following criteria must not be enrolled in the study:
1.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)
2.History of treated diabetic gastroparesis
3.Current ongoing symptomatic biliary disease or history of pancreatitis
4.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
5.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 I to IV).
Note: Investigators must consult the approved product labeling for TZD in their country to determine a subjects? eligibility to participate in this study if they are currently taking a TZD1
?Resting systolic pressure is >160 mm Hg and/or diastolic pressure >100 mm Hg. If the subject?s systolic blood pressure is >160 mm Hg or the subject?s diastolic blood pressure is >100 mm Hg at Screening, the blood pressure readings may be repeated at 5-minute intervals for a total of 3 determinations. If the averages of the systolic or diastolic pressure readings still do 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 documents2
?QTc interval (Fridericia) >470 ms confirmed by a central reader at Screening
6.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)
7.Hemoglobinopathy that may affect determination of HbA1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method