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

NCT ID: NCT00976391

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 586 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-05-31

Brief Summary

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.

Detailed Description

This randomized, open-label, active-controlled, parallel-group, multicenter study evaluates the safety and efficacy of a weekly subcutaneously injected dose 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. Subjects with a historical diagnosis of type 2 diabetes who are inadequately controlled despite the use of insulin glargine or other intermediate- or long-acting insulins for >/= 6 months but < 5 years, with or without oral antidiabetic medications, who are unable to achieve a glycosylated hemoglobin value of < 7% will be recruited into the study. Subjects must also be willing and capable of pursuing an intensive regimen of both basal and preprandial insulin.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

albiglutide + insulin glargine

albiglutide in combination with insulin glargine

Group Type: ACTIVE_COMPARATOR

albiglutide + insulin glargine

Intervention Type: BIOLOGICAL

albiglutide in combination with insulin glargine

insulin glargine + preprandial lispro insulin

insulin glargine in combination with preprandial lispro insulin

Group Type: ACTIVE_COMPARATOR

insulin glargine + preprandial lispro insulin

Intervention Type: DRUG

insulin glargine in combination with preprandial lispro insulin

Interventions

albiglutide + insulin glargine

albiglutide in combination with insulin glargine

Intervention Type: BIOLOGICAL

insulin glargine + preprandial lispro insulin

insulin glargine in combination with preprandial lispro insulin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Koyang-shi, , South Korea

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Suwon, Kyonggi-do, , South Korea

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Hull, , United Kingdom

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Plymouth, , United Kingdom

Countries

United States; Brazil; France; Germany; Hong Kong; India; Mexico; Peru; Philippines; South Africa; South Korea; Spain; Taiwan; United Kingdom

References

Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.

Reference Type: DERIVED

PMID: 24898300 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Other Identifiers

108486

Identifier Type: -

Identifier Source: org_study_id