Last updated: 11/07/2018 02:16:22
A study to determine the safety and efficacy of albiglutide administered in combination with insulin glargine
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (BL) in glycosylated hemoglobin (HbA1c) at Week 26
Timeframe: Baseline and Week 26
Secondary outcomes:
Change from Baseline in HbA1c at Weeks 36, 48 and 52
Timeframe: Baseline and Weeks 36, 48 and 52
Change from Baseline in fasting plasma glucose (FPG) at Week 26
Timeframe: Baseline and Week 26
Change from Baseline in fasting plasma glucose (FPG) at Weeks 36, 48 and 52
Timeframe: Baseline and Weeks 36, 48 and 52
Number of participants who achieved HbA1c response level of <6.5% and <7.0% at Week 26
Timeframe: Week 26
Time to hyperglycemia rescue
Timeframe: 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
Timeframe: Baseline and Week 26
Change from Baseline in body weight at Weeks 36, 48 and 52
Timeframe: Baseline and Weeks 36, 48 and 52
Interventions:
Biological/vaccine: albiglutide + insulin glargine
Drug: insulin glargine + preprandial lispro insulin
Enrollment:
586
Observational study model:
Not applicable
Primary completion date:
2012-02-05
Time perspective:
Not applicable
Clinical publications:
Julio Rosenstock, Vivian Fonseca, Robert Ratner, Jorge Gross, Bo Ahren, Francis Chow, Fred Yang, Diane Miller, Susan Johnson, Murray Stewart, Lawrence Leiter for the HARMONY 6 Study Group. Harmony 6: 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;37:2317-2325.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
September 2009 to May 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- 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
- 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
Inclusion and exclusion 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
- 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 /=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
- 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
Recent clinically significant cardiovascular and/or cerebrovascular disease including but not limited to the following:
Trial location(s)
Location
GSK Investigational Site
Searcy, Arkansas, United States, 72143
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29601
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Haverhill, Massachusetts, United States, 01830
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78404
Status
Study Complete
Location
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
Status
Study Complete
Location
GSK Investigational Site
Morehead City, North Carolina, United States, 28557
Status
Study Complete
Location
GSK Investigational Site
Hampton, Virginia, United States, 23666
Status
Study Complete
Location
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
North Richland Hills, Texas, United States, 76180
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Katy, Texas, United States, 77450
Status
Terminated/Withdrawn
Location
GSK Investigational Site
McKenzie, Tennessee, United States, 38201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
LaJolla, California, United States, 92037
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85028
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30338
Status
Study Complete
Location
GSK Investigational Site
Great Falls, Montana, United States, 59405
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28803
Status
Study Complete
Location
GSK Investigational Site
Murrells Inlet, South Carolina, United States, 29576
Status
Study Complete
Location
GSK Investigational Site
Manassas, Virginia, United States, 20110
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65807
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92161
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90073
Status
Study Complete
Location
GSK Investigational Site
Carlisle, Pennsylvania, United States, 17013
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Canal Fulton, Ohio, United States, 44614
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84102
Status
Study Complete
Location
GSK Investigational Site
Seongnam-si,, South Korea, 463-707
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78215
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Savannah, Georgia, United States, 31419
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35205
Status
Study Complete
Location
GSK Investigational Site
Pretoria, Gauteng, South Africa, 00083
Status
Study Complete
Location
GSK Investigational Site
Snellville, Georgia, United States, 30078
Status
Study Complete
Location
GSK Investigational Site
Gilbert, Arizona, United States, 85295
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Study Complete
Location
GSK Investigational Site
Chino, California, United States, 91710
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92646
Status
Study Complete
Location
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Status
Study Complete
Location
GSK Investigational Site
Idaho Falls, Idaho, United States, 83404
Status
Study Complete
Location
GSK Investigational Site
Cutler Bay, Florida, United States, 33189
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40504
Status
Study Complete
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Indiana, United States, 47904
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L7 8XP
Status
Study Complete
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50314
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Haddon Heights, New Jersey, United States, 08035
Status
Study Complete
Location
GSK Investigational Site
North Massapequa, New York, United States, 11758
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76012
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bloomfield Hills, Michigan, United States, 48302
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77478
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38125
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Commerce, California, United States, 90040
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96814
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Benzonia, Michigan, United States, 49616
Status
Study Complete
Location
GSK Investigational Site
Satna Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95821
Status
Study Complete
Location
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4068
Status
Study Complete
Location
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Status
Study Complete
Location
GSK Investigational Site
Dearborn, Michigan, United States, 48124
Status
Study Complete
Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Study Complete
Location
GSK Investigational Site
Picayune, Mississippi, United States, 39466
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84124
Status
Study Complete
Location
GSK Investigational Site
Los Alamitos, California, United States, 90720
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80220
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
Status
Study Complete
Location
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 01820
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tullahoma, Tennessee, United States, 37398
Status
Study Complete
Location
GSK Investigational Site
Tustin, California, United States, 92780
Status
Study Complete
Location
GSK Investigational Site
Boksburg North, Gauteng, South Africa, 1459
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Burlington, North Carolina, United States, 27215
Status
Study Complete
Location
GSK Investigational Site
New Britain, Connecticut, United States, 06050
Status
Study Complete
Location
GSK Investigational Site
Lauderdale Lakes, Florida, United States, 33319
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10025
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33317
Status
Study Complete
Location
GSK Investigational Site
Lewisburg, West Virginia, United States, 24901
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
La Grange, Illinois, United States, 60525
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99216
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92037
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48106
Status
Study Complete
Location
GSK Investigational Site
Bensalem, Pennsylvania, United States, 19020
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tipton, Pennsylvania, United States, 16684
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Hyattsville, Maryland, United States, 20782
Status
Study Complete
Location
GSK Investigational Site
West Hills, California, United States, 91307
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78218
Status
Study Complete
Location
GSK Investigational Site
Council Bluffs, Iowa, United States, 51501
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37604
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-02-05
Actual study completion date
2012-02-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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