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

November 21, 2016 updated by: GlaxoSmithKline

A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

586

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- - Brasília, Brazil, 71625-009
    - GSK Investigational Site
  - Mogi das Cruzes, Brazil, 08780 - 090
    - GSK Investigational Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170
    - GSK Investigational Site
France
- - Armentières, France, 59280
    - GSK Investigational Site
  - Venissieux, France, 69200
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10115
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Witten, Nordrhein-Westfalen, Germany, 58455
    - GSK Investigational Site
- Rheinland-Pfalz
  - Mainz, Rheinland-Pfalz, Germany, 55116
    - GSK Investigational Site
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
Hong Kong
- - Shatin, Hong Kong
    - GSK Investigational Site
India
- - Bangalore, India, 560 054
    - GSK Investigational Site
  - Bangalore, India, 560043
    - GSK Investigational Site
  - Bangalore, India, 560052
    - GSK Investigational Site
  - Chennai, India, 600020
    - GSK Investigational Site
  - Manipal, India, 576104
    - GSK Investigational Site
Korea, Republic of
- - Goyang-si, Korea, Republic of, 411706
    - GSK Investigational Site
  - Koyang-shi, Korea, Republic of, 411710
    - GSK Investigational Site
  - Seongnam-si, Korea, Republic of, 463712
    - GSK Investigational Site
  - Seongnam-si,, Korea, Republic of, 463-707
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 137-701
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-720
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 139-872
    - GSK Investigational Site
  - Suwon, Kyonggi-do, Korea, Republic of, 443-721
    - GSK Investigational Site
Mexico
- - Mexico City, Mexico, 03300
    - GSK Investigational Site
  - Puebla, Mexico, 72190
    - GSK Investigational Site
- Hidalgo
  - Pachuca, Hidalgo, Mexico, 42086
    - GSK Investigational Site
Peru
- - Ica, Peru, 11
    - GSK Investigational Site
  - Lima, Peru, 01
    - GSK Investigational Site
  - Piura, Peru
    - GSK Investigational Site
  - Trujillo, Peru
    - GSK Investigational Site
- Lima
  - Huacho, Lima, Peru
    - GSK Investigational Site
Philippines
- - Marikina City, Philippines, 1810
    - GSK Investigational Site
  - Pasay, Philippines, 1300
    - GSK Investigational Site
  - Pasig, Philippines, 1600
    - GSK Investigational Site
  - Quezon City, Philippines, 1102
    - GSK Investigational Site
  - San Juan, Philippines, 1500
    - GSK Investigational Site
  - Tagbilaran City, Philippines, 6300
    - GSK Investigational Site
  - Taytay Rizal, Philippines, 1920
    - GSK Investigational Site
South Africa
- - Bellville, South Africa, 7530
    - GSK Investigational Site
  - Cape Town, South Africa, 7530
    - GSK Investigational Site
  - Kempton Park, South Africa, 1619
    - GSK Investigational Site
  - Parow, South Africa, 7505
    - GSK Investigational Site
  - Somerset West, South Africa, 7130
    - GSK Investigational Site
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6014
    - GSK Investigational Site
- Gauteng
  - Boksburg North, Gauteng, South Africa, 1459
    - GSK Investigational Site
  - Johannesburg, Gauteng, South Africa, 2013
    - GSK Investigational Site
  - Johannesburg, Gauteng, South Africa, 2193
    - GSK Investigational Site
  - Johannesburg, Gauteng, South Africa, 01820
    - GSK Investigational Site
  - Lenasia, Gauteng, South Africa, 1827
    - GSK Investigational Site
  - Pretoria, Gauteng, South Africa, 00083
    - GSK Investigational Site
- KwaZulu- Natal
  - Durban, KwaZulu- Natal, South Africa, 4000
    - GSK Investigational Site
  - Durban, KwaZulu- Natal, South Africa, 4068
    - GSK Investigational Site
Spain
- - Alzira, Spain, 46600
    - GSK Investigational Site
  - Barcelona, Spain, 08022
    - GSK Investigational Site
  - Madrid, Spain, 28034
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07010
    - GSK Investigational Site
  - Sabadell, Spain, 08208
    - GSK Investigational Site
  - Sevilla, Spain, 41003
    - GSK Investigational Site
Taiwan
- - Taichung, Taiwan, 404
    - GSK Investigational Site
  - Tainan, Taiwan, 71044
    - GSK Investigational Site
  - Taipei, Taiwan, 100
    - GSK Investigational Site
  - Taipei, Taiwan, 11490
    - GSK Investigational Site
  - Taipei County, Taiwan, 23137
    - GSK Investigational Site
United Kingdom
- - Hull, United Kingdom, HU3 2RW
    - GSK Investigational Site
  - London, United Kingdom, SE 1 9RT
    - GSK Investigational Site
  - Plymouth, United Kingdom, PL6 8BX
    - GSK Investigational Site
- Merseyside
  - Liverpool, Merseyside, United Kingdom, L7 8XP
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - GSK Investigational Site
  - Dothan, Alabama, United States, 36301
    - GSK Investigational Site
- Arizona
  - Gilbert, Arizona, United States, 85295
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85050
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85028
    - GSK Investigational Site
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - GSK Investigational Site
  - Searcy, Arkansas, United States, 72143
    - GSK Investigational Site
- California
  - Chino, California, United States, 91710
    - GSK Investigational Site
  - Commerce, California, United States, 90040
    - GSK Investigational Site
  - Fresno, California, United States, 93720
    - GSK Investigational Site
  - Fullerton, California, United States, 92835
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92646
    - GSK Investigational Site
  - La Jolla, California, United States, 92037
    - GSK Investigational Site
  - LaJolla, California, United States, 92037
    - GSK Investigational Site
  - Long Beach, California, United States, 90806
    - GSK Investigational Site
  - Los Alamitos, California, United States, 90720
    - GSK Investigational Site
  - Los Angeles, California, United States, 90073
    - GSK Investigational Site
  - Mission Viejo, California, United States, 92691
    - GSK Investigational Site
  - Sacramento, California, United States, 95821
    - GSK Investigational Site
  - San Diego, California, United States, 92161
    - GSK Investigational Site
  - San Diego, California, United States, 92117
    - GSK Investigational Site
  - San Diego, California, United States, 92128
    - GSK Investigational Site
  - Satna Monica, California, United States, 90404
    - GSK Investigational Site
  - Spring Valley, California, United States, 91978
    - GSK Investigational Site
  - Tustin, California, United States, 92780
    - GSK Investigational Site
  - Walnut Creek, California, United States, 94598
    - GSK Investigational Site
  - West Hills, California, United States, 91307
    - GSK Investigational Site
- Colorado
  - Denver, Colorado, United States, 80220
    - GSK Investigational Site
- Connecticut
  - New Britain, Connecticut, United States, 06050
    - GSK Investigational Site
  - Trumbull, Connecticut, United States, 06611
    - GSK Investigational Site
  - Waterbury, Connecticut, United States, 06708
    - GSK Investigational Site
- Florida
  - Boynton Beach, Florida, United States, 33437
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33756
    - GSK Investigational Site
  - Cutler Bay, Florida, United States, 33189
    - GSK Investigational Site
  - Hallandale Beach, Florida, United States, 33009
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32205
    - GSK Investigational Site
  - Lauderdale Lakes, Florida, United States, 33319
    - GSK Investigational Site
  - Miami, Florida, United States, 33156
    - GSK Investigational Site
  - Orlando, Florida, United States, 32822
    - GSK Investigational Site
  - Plantation, Florida, United States, 33317
    - GSK Investigational Site
  - West Palm Beach, Florida, United States, 33401
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30308
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30338
    - GSK Investigational Site
  - Blue Ridge, Georgia, United States, 30513
    - GSK Investigational Site
  - Columbus, Georgia, United States, 31904
    - GSK Investigational Site
  - Savannah, Georgia, United States, 31419
    - GSK Investigational Site
  - Snellville, Georgia, United States, 30078
    - GSK Investigational Site
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - GSK Investigational Site
  - Honolulu, Hawaii, United States, 96814
    - GSK Investigational Site
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - GSK Investigational Site
- Illinois
  - La Grange, Illinois, United States, 60525
    - GSK Investigational Site
- Indiana
  - Avon, Indiana, United States, 46123
    - GSK Investigational Site
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site
  - Lafayette, Indiana, United States, 47904
    - GSK Investigational Site
- Iowa
  - Council Bluffs, Iowa, United States, 51501
    - GSK Investigational Site
  - Des Moines, Iowa, United States, 50314
    - GSK Investigational Site
  - Iowa City, Iowa, United States, 52243
    - GSK Investigational Site
- Kansas
  - Newton, Kansas, United States, 67114
    - GSK Investigational Site
  - Topeka, Kansas, United States, 66606
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40504
    - GSK Investigational Site
  - Lexington, Kentucky, United States, 40503
    - GSK Investigational Site
- Louisiana
  - Shreveport, Louisiana, United States, 71101
    - GSK Investigational Site
- Maryland
  - Hyattsville, Maryland, United States, 20782
    - GSK Investigational Site
- Massachusetts
  - Haverhill, Massachusetts, United States, 01830
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - GSK Investigational Site
  - Benzonia, Michigan, United States, 49616
    - GSK Investigational Site
  - Bloomfield Hills, Michigan, United States, 48302
    - GSK Investigational Site
  - Dearborn, Michigan, United States, 48124
    - GSK Investigational Site
  - Kalamazoo, Michigan, United States, 49009
    - GSK Investigational Site
  - Kalamazoo, Michigan, United States, 49048
    - GSK Investigational Site
- Mississippi
  - Picayune, Mississippi, United States, 39466
    - GSK Investigational Site
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - GSK Investigational Site
  - Jefferson City, Missouri, United States, 65109
    - GSK Investigational Site
  - Kansas City, Missouri, United States
    - GSK Investigational Site
  - Springfield, Missouri, United States, 65807
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63141
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63110
    - GSK Investigational Site
- Montana
  - Great Falls, Montana, United States, 59405
    - GSK Investigational Site
- Nebraska
  - Omaha, Nebraska, United States, 68131
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68124
    - GSK Investigational Site
- New Jersey
  - Haddon Heights, New Jersey, United States, 08035
    - GSK Investigational Site
- New York
  - New York, New York, United States, 10025
    - GSK Investigational Site
  - North Massapequa, New York, United States, 11758
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - GSK Investigational Site
  - Burlington, North Carolina, United States, 27215
    - GSK Investigational Site
  - Durham, North Carolina, United States, 27710
    - GSK Investigational Site
  - Hickory, North Carolina, United States, 28601
    - GSK Investigational Site
  - Morehead City, North Carolina, United States, 28557
    - GSK Investigational Site
  - Tabor City, North Carolina, United States, 28463
    - GSK Investigational Site
- Ohio
  - Akron, Ohio, United States, 44320
    - GSK Investigational Site
  - Canal Fulton, Ohio, United States, 44614
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45245
    - GSK Investigational Site
  - Cleveland, Ohio, United States, 44122
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43213
    - GSK Investigational Site
  - Dayton, Ohio, United States, 45439
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73104
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74104
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74136
    - GSK Investigational Site
- Pennsylvania
  - Bensalem, Pennsylvania, United States, 19020
    - GSK Investigational Site
  - Carlisle, Pennsylvania, United States, 17013
    - GSK Investigational Site
  - Tipton, Pennsylvania, United States, 16684
    - GSK Investigational Site
  - Uniontown, Pennsylvania, United States, 15401
    - GSK Investigational Site
- South Carolina
  - Greenville, South Carolina, United States, 29615
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29601
    - GSK Investigational Site
  - Murrells Inlet, South Carolina, United States, 29576
    - GSK Investigational Site
- Tennessee
  - Clarksville, Tennessee, United States, 37043
    - GSK Investigational Site
  - Johnson City, Tennessee, United States, 37604
    - GSK Investigational Site
  - McKenzie, Tennessee, United States, 38201
    - GSK Investigational Site
  - Memphis, Tennessee, United States, 38125
    - GSK Investigational Site
  - Tullahoma, Tennessee, United States, 37398
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 76012
    - GSK Investigational Site
  - Bedford, Texas, United States, 76201
    - GSK Investigational Site
  - Corpus Christi, Texas, United States, 78404
    - GSK Investigational Site
  - Dallas, Texas, United States, 75246
    - GSK Investigational Site
  - Dallas, Texas, United States, 75230
    - GSK Investigational Site
  - Dallas, Texas, United States, 75224
    - GSK Investigational Site
  - Dallas, Texas, United States, 75251
    - GSK Investigational Site
  - El Paso, Texas, United States, 79925
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77074
    - GSK Investigational Site
  - Houston, Texas, United States, 77024
    - GSK Investigational Site
  - Houston, Texas, United States, 77058
    - GSK Investigational Site
  - Katy, Texas, United States, 77450
    - GSK Investigational Site
  - Lake Jackson, Texas, United States, 77566
    - GSK Investigational Site
  - Midland, Texas, United States, 79707
    - GSK Investigational Site
  - North Richland Hills, Texas, United States, 76180
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78215
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78218
    - GSK Investigational Site
  - Schertz, Texas, United States, 78154
    - GSK Investigational Site
  - Sugar Land, Texas, United States, 77478
    - GSK Investigational Site
  - Temple, Texas, United States, 76508
    - GSK Investigational Site
- Utah
  - Bountiful, Utah, United States, 84010
    - GSK Investigational Site
  - Salt Lake City, Utah, United States, 84102
    - GSK Investigational Site
  - Salt Lake City, Utah, United States, 84124
    - GSK Investigational Site
- Vermont
  - South Burlington, Vermont, United States, 05403
    - GSK Investigational Site
- Virginia
  - Burke, Virginia, United States, 22015
    - GSK Investigational Site
  - Hampton, Virginia, United States, 23666
    - GSK Investigational Site
  - Manassas, Virginia, United States, 20110
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23294
    - GSK Investigational Site
- Washington
  - Spokane, Washington, United States, 99216
    - GSK Investigational Site
  - Tacoma, Washington, United States, 98405
    - GSK Investigational Site
- West Virginia
  - Lewisburg, West Virginia, United States, 24901
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: albiglutide + insulin glargine albiglutide in combination with insulin glargine	Biological: albiglutide + insulin glargine albiglutide in combination with insulin glargine
Active Comparator: insulin glargine + preprandial lispro insulin insulin glargine in combination with preprandial lispro insulin	Drug: insulin glargine + preprandial lispro insulin insulin glargine in combination with preprandial lispro insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26 Time Frame: Baseline and Week 26	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.	Baseline and Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c at Weeks 36, 48 and 52 Time Frame: Baseline and Weeks 36, 48 and 52	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Weeks 36, 48 and 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Time Frame: Baseline and Week 26	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region	Baseline and Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52 Time Frame: Baseline and Weeks 36, 48 and 52	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Weeks 36, 48 and 52
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26 Time Frame: Week 26	The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7.0% at Week 26) were assessed.	Week 26
Time to Hyperglycemia Rescue Time Frame: From the start of study medication until the end of the treatment (up to Week 52)	Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 4 and <Week 8; HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 8 and <Week 12; HbA1c >8.5% and >=4 weeks since uptitration between >=Week 12 and <Week 16; HbA1c >8.0% and >=4 weeks since uptitration; HbA1c >7.5% and >=4 weeks between >Week 26 and >=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.	From the start of study medication until the end of the treatment (up to Week 52)
Change From Baseline in Body Weight at Week 26 Time Frame: Baseline and Week 26	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy.	Baseline and Week 26
Change From Baseline in Body Weight at Weeks 36, 48 and 52 Time Frame: Baseline and Weeks 36, 48 and 52	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Weeks 36, 48 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

108486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Study Protocol
Information identifier: 108486

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 108486

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 108486

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 108486

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 108486

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 108486

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 108486

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

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Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

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Sponsor

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on albiglutide + insulin glargine

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