AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT00976391

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

A Phase 3 study testing albiglutide + insulin glargine and insulin glargine + preprandial lispro insulin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 209 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
albiglutide + insulin glargine and insulin glargine + preprandial lispro insulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
586 participants
Where
209 sitesin 14 countries
Study dates
Sep 2009to May 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

209 sites in 14 countries.

209 sites in 14 countries

United States142 sites

  • GSK Investigational Site

    Akron, Ohio, 44320

  • GSK Investigational Site

    Ann Arbor, Michigan, 48106

  • GSK Investigational Site

    Arlington, Texas, 76012

  • GSK Investigational Site

    Asheville, North Carolina, 28803

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Bedford, Texas, 76201

  • GSK Investigational Site

    Bensalem, Pennsylvania, 19020

  • GSK Investigational Site

    Benzonia, Michigan, 49616

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Bloomfield Hills, Michigan, 48302

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Bountiful, Utah, 84010

  • GSK Investigational Site

    Boynton Beach, Florida, 33437

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Burlington, North Carolina, 27215

  • GSK Investigational Site

    Canal Fulton, Ohio, 44614

  • GSK Investigational Site

    Carlisle, Pennsylvania, 17013

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Chino, California, 91710

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Columbus, Ohio, 43213

  • GSK Investigational Site

    Commerce, California, 90040

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Council Bluffs, Iowa, 51501

  • GSK Investigational Site

    Cutler Bay, Florida, 33189

  • GSK Investigational Site

    Dallas, Texas, 75224

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Dallas, Texas, 75251

  • GSK Investigational Site

    Dayton, Ohio, 45439

  • GSK Investigational Site

    Dearborn, Michigan, 48124

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Des Moines, Iowa, 50314

  • GSK Investigational Site

    Dothan, Alabama, 36301

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    El Paso, Texas, 79925

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Gilbert, Arizona, 85295

  • GSK Investigational Site

    Great Falls, Montana, 59405

  • GSK Investigational Site

    Greenville, South Carolina, 29601

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Haddon Heights, New Jersey, 08035

  • GSK Investigational Site

    Hallandale, Florida, 33009

  • GSK Investigational Site

    Hampton, Virginia, 23666

  • GSK Investigational Site

    Haverhill, Massachusetts, 01830

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Honolulu, Hawaii, 96813

  • GSK Investigational Site

    Honolulu, Hawaii, 96814

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77058

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Huntington Beach, California, 92646

  • GSK Investigational Site

    Hyattsville, Maryland, 20782

  • GSK Investigational Site

    Idaho Falls, Idaho, 83404

  • GSK Investigational Site

    Iowa City, Iowa, 52243

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jefferson City, Missouri, 65109

  • GSK Investigational Site

    Johnson City, Tennessee, 37604

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kalamazoo, Michigan, 49009

  • GSK Investigational Site

    Kalamazoo, Michigan, 49048

  • GSK Investigational Site

    Kansas City, Missouri

  • GSK Investigational Site

    Katy, Texas, 77450

  • GSK Investigational Site

    La Grange, Illinois, 60525

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Lafayette, Indiana, 47904

  • GSK Investigational Site

    Lake Jackson, Texas, 77566

  • GSK Investigational Site

    Lauderdale Lakes, Florida, 33319

  • GSK Investigational Site

    Lewisburg, West Virginia, 24901

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    Lexington, Kentucky, 40504

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Los Alamitos, California, 90720

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • GSK Investigational Site

    McKenzie, Tennessee, 38201

  • GSK Investigational Site

    Memphis, Tennessee, 38125

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Midland, Texas, 79707

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    Morehead City, North Carolina, 28557

  • GSK Investigational Site

    Murrells Inlet, South Carolina, 29576

  • GSK Investigational Site

    New Britain, Connecticut, 06050

  • GSK Investigational Site

    New York, New York, 10025

  • GSK Investigational Site

    Newton, Kansas, 67114

  • GSK Investigational Site

    North Massapequa, New York, 11758

  • GSK Investigational Site

    North Richland Hills, Texas, 76180

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Omaha, Nebraska, 68124

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Phoenix, Arizona, 85028

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • GSK Investigational Site

    Picayune, Mississippi, 39466

  • GSK Investigational Site

    Plantation, Florida, 33317

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Sacramento, California, 95821

  • GSK Investigational Site

    Salt Lake City, Utah, 84102

  • GSK Investigational Site

    Salt Lake City, Utah, 84124

  • GSK Investigational Site

    San Antonio, Texas, 78215

  • GSK Investigational Site

    San Antonio, Texas, 78218

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    San Diego, California, 92161

  • GSK Investigational Site

    Satna Monica, California, 90404

  • GSK Investigational Site

    Savannah, Georgia, 31419

  • GSK Investigational Site

    Schertz, Texas, 78154

  • GSK Investigational Site

    Searcy, Arkansas, 72143

  • GSK Investigational Site

    Shreveport, Louisiana, 71101

  • GSK Investigational Site

    Snellville, Georgia, 30078

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    Spokane, Washington, 99216

  • GSK Investigational Site

    Spring Valley, California, 91978

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Sugar Land, Texas, 77478

  • GSK Investigational Site

    Tabor City, North Carolina, 28463

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Temple, Texas, 76508

  • GSK Investigational Site

    Tipton, Pennsylvania, 16684

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Trumbull, Connecticut, 06611

  • GSK Investigational Site

    Tullahoma, Tennessee, 37398

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Tustin, California, 92780

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Waterbury, Connecticut, 06708

  • GSK Investigational Site

    West Hills, California, 91307

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

Other trials in United States

South Africa14 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Boksburg North, Gauteng, 1459

  • GSK Investigational Site

    Cape Town, 7530

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4000

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4068

  • GSK Investigational Site

    Johannesburg, Gauteng, 01820

  • GSK Investigational Site

    Johannesburg, Gauteng, 2013

  • GSK Investigational Site

    Johannesburg, Gauteng, 2193

  • GSK Investigational Site

    Kempton Park, 1619

  • GSK Investigational Site

    Lenasia, Gauteng, 1827

  • GSK Investigational Site

    Parow, 7505

  • GSK Investigational Site

    Port Elizabeth, Eastern Cape, 6014

  • GSK Investigational Site

    Pretoria, Gauteng, 00083

  • GSK Investigational Site

    Somerset West, 7130

Other trials in South Africa

South Korea8 sites

  • GSK Investigational Site

    Goyang-si, 411706

  • GSK Investigational Site

    Koyang-shi, 411710

  • GSK Investigational Site

    Seongnam-si, 463-707

  • GSK Investigational Site

    Seongnam-si, 463712

  • GSK Investigational Site

    Seoul, 135-720

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 139-872

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Philippines7 sites

  • GSK Investigational Site

    Marikina City, 1810

  • GSK Investigational Site

    Pasay, 1300

  • GSK Investigational Site

    Pasig, 1600

  • GSK Investigational Site

    Quezon City, 1102

  • GSK Investigational Site

    San Juan City, 1500

  • GSK Investigational Site

    Tagbilaran City, 6300

  • GSK Investigational Site

    Taytay Rizal, 1920

Other trials in Philippines

Spain6 sites

  • GSK Investigational Site

    Alzira, 46600

  • GSK Investigational Site

    Barcelona, 08022

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Sabadell, 08208

  • GSK Investigational Site

    Seville, 41003

Other trials in Spain

India5 sites

  • GSK Investigational Site

    Bangalore, 560 054

  • GSK Investigational Site

    Bangalore, 560043

  • GSK Investigational Site

    Bangalore, 560052

  • GSK Investigational Site

    Chennai, 600020

  • GSK Investigational Site

    Manipal, 576104

Other trials in India

Peru5 sites

  • GSK Investigational Site

    Huacho, Lima region

  • GSK Investigational Site

    Ica, Ica, 11

  • GSK Investigational Site

    Lima, Lima Province, 01

  • GSK Investigational Site

    Piura, Piura

  • GSK Investigational Site

    Trujillo

Other trials in Peru

Taiwan5 sites

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Tainan, 71044

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 11490

  • GSK Investigational Site

    Taipei County, 23137

Other trials in Taiwan

Germany4 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 10115

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

United Kingdom4 sites

  • GSK Investigational Site

    Hull, HU3 2RW

  • GSK Investigational Site

    Liverpool, Merseyside, L7 8XP

  • GSK Investigational Site

    London, SE 1 9RT

  • GSK Investigational Site

    Plymouth, PL6 8BX

Other trials in United Kingdom

Brazil3 sites

  • GSK Investigational Site

    Brasília, 71625-009

  • GSK Investigational Site

    Mogi das Cruzes, 08780 - 090

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-170

Other trials in Brazil

Mexico3 sites

  • GSK Investigational Site

    Mexico City, 03300

  • GSK Investigational Site

    Pachuca, Hidalgo, 42086

  • GSK Investigational Site

    Puebla City, Puebla, 72190

Other trials in Mexico

France2 sites

  • GSK Investigational Site

    Armentières, 59280

  • GSK Investigational Site

    Vénissieux, 69200

Other trials in France

Hong Kong1 site

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
albiglutide + insulin glargine, insulin glargine + preprandial lispro insulin
Keywords
open-label, albiglutide, insulin glargine, preprandial insulin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • albiglutide + insulin glargineBiological

    albiglutide in combination with insulin glargine

  • insulin glargine + preprandial lispro insulinDrug

    insulin glargine in combination with preprandial lispro insulin

Study groups in NCT00976391
Study groupRoleWhat they receive
albiglutide + insulin glargineActive comparatoralbiglutide in combination with insulin glargine
Receives: Biological: albiglutide + insulin glargine
insulin glargine + preprandial lispro insulinActive comparatorinsulin glargine in combination with preprandial lispro insulin
Receives: Drug: insulin glargine + preprandial lispro insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at 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.

    Measured: Baseline and Week 26

Secondary outcomes (7)

  1. Change From Baseline in HbA1c at 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.

    Measured: Baseline and Weeks 36, 48 and 52

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at 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

    Measured: Baseline and Week 26

  3. Change From Baseline in Fasting Plasma Glucose (FPG) at 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.

    Measured: Baseline and Weeks 36, 48 and 52

  4. Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at 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.

    Measured: Week 26

  5. Time to Hyperglycemia Rescue

    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.

    Measured: From the start of study medication until the end of the treatment (up to Week 52)

  6. Change From Baseline in Body Weight at 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.

    Measured: Baseline and Week 26

  7. Change From Baseline in Body Weight at 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.

    Measured: Baseline and Weeks 36, 48 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionOct 2011
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
586 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976391
Sponsor's protocol ID
108486
Status last verified
Nov 2016
First submitted
11 Sep 2009
Last updated
11 Jan 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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.

    PubMed 24898300

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing albiglutide + insulin glargine and insulin glargine + preprandial lispro insulin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 209 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, South Africa, South Korea, Philippines, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline and Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00976391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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