Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study
2 other identifiers
interventional
814
14 countries
157
Brief Summary
This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Nov 2014
Longer than P75 for phase_3 diabetes-mellitus-type-2
157 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2014
CompletedFirst Posted
Study publicly available on registry
September 1, 2014
CompletedStudy Start
First participant enrolled
November 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2017
CompletedResults Posted
Study results publicly available
June 29, 2018
CompletedNovember 27, 2020
November 1, 2020
2.7 years
August 28, 2014
June 1, 2018
November 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Baseline (Day -1) and Week 26
Secondary Outcomes (39)
Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26
Up to Week 26
Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26
Up to Week 26
Change From Baseline in Body Weight at Week 26
Baseline (Day -1) and Week 26
Change From Baseline to Week 26 in Body Weight
Baseline (Day -1) to Week 26
Total Daily Insulin Dose at Week 26
Week 26
- +34 more secondary outcomes
Study Arms (2)
Albiglutide + Insulin Glargine Arm
EXPERIMENTALDuring standardization period, subjects will transit from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. During treatment period, subject will receive Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection and insulin lispro dose will be downtitrated to half that used in the standardization period. At Week 4, Albiglutide will be uptitrated to 50 mg weekly SC injection and insulin lispro will be stopped for the remainder of the treatment Period. Insulin lispro may be re-introduced after Week 8 according to pre-defined hyperglycemia thresholds. Insulin will be adjusted according to protocol-defined insulin titration algorithms
Insulin Glargine + Insulin Lispro Arm
EXPERIMENTALDuring standardization period, subjects will transit from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. During treatment period, subject will continue with the same doses as at the end of the standardization period and doses will be adjusted according to protocol-defined insulin titration algorithms
Interventions
Albiglutide is intended for self-administration as a SC injection. It is provided as a fixed dose of 30 mg of albiglutide or 50 mg of albiglutide in a 0.5 mL injection volume, fully disposable pen injector
Insulin glargine and insulin lispro will be provided as injection pens for SC injection
Eligibility Criteria
You may qualify if:
- Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM
- HbA1c \>= 7.0% and \<= 9.0% at Screening.
- Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following:
- Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND
- Bolus insulin (at least 2 injections of regular insulin, insulin glulisine, insulin aspart, or insulin lispro) with a total daily dose of bolus insulin \<= 70 units
- In addition, the total daily dose of insulin must be \<= 140 units
- If taking metformin, a stable dose for at least 8 weeks before Screening Note: Subject should not have received any other antidiabetic medication within 30 days before screening (e.g., glucagon-like peptide-1 receptor (GLP-1R) agonist, dipeptidyl peptidase-IV inhibitor, SU, or thiazolidinedione). Subjects receiving commercially available premixed basal and prandial insulin are not eligible for this study.
- Fasting C-peptide \>= 0.8 nanogram (ng) per milliliter (mL) \[\>= 0.26 nanomoles per litre (nmol/L)\]
- Body mass index \<= 40 kilogram per square meter( kg/m\^2)
- Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4)
- Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (as defined in the protocol) for the duration of participation in the study including the 4-week post treatment Follow-up Period..
- Willing and able to comply with all study procedures including performance of frequent self-monitored blood glucose (SMBG) profiles according to the protocol
- Able and willing to provide written informed consent
You may not qualify if:
- Type 1 diabetes mellitus
- History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Current symptomatic biliary disease or history of acute or chronic pancreatitis
- Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening
- History of significant GI surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function \[e.g., gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function\]
- History of severe hypoglycemia unawareness
- Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product
- Clinically significant CV and/or cerebrovascular disease within 3 months before Screening including, but not limited to, the following:
- Stroke or transient ischemic attack
- Acute coronary syndrome (myocardial infarction \[MI\] or unstable angina not responsive to nitroglycerin)
- Cardiac surgery or percutaneous coronary procedure
- Current or history of heart failure (New York Heart Association class III or IV)
- Alanine aminotransferase (ALT) \>2.5 × upper limit of normal (ULN) or bilirubin \>1.5 × ULN (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and is not on active antiviral treatment \[e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of Screening\])
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- PPD Development, LPcollaborator
Study Sites (157)
GSK Investigational Site
Searcy, Arkansas, 72143, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
Long Beach, California, 90807, United States
GSK Investigational Site
Los Angeles, California, 90017, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
West Hills, California, 91307, United States
GSK Investigational Site
Colorado Springs, Colorado, 80909, United States
GSK Investigational Site
Brooksville, Florida, 34601, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Hialeah, Florida, 33012, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Orlando, Florida, 32825, United States
GSK Investigational Site
Pembroke Pines, Florida, 33027, United States
GSK Investigational Site
Tampa, Florida, 33634, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Paducah, Kentucky, 42003, United States
GSK Investigational Site
Lake Charles, Louisiana, 70601, United States
GSK Investigational Site
Shreveport, Louisiana, 71105, United States
GSK Investigational Site
Kalamazoo, Michigan, 49009, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Staten Island, New York, 10301, United States
GSK Investigational Site
Shelby, North Carolina, 28150, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Columbus, Ohio, 43213, United States
GSK Investigational Site
Dayton, Ohio, 45439, United States
GSK Investigational Site
Kettering, Ohio, 45429, United States
GSK Investigational Site
Austin, Texas, 78749, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Houston, Texas, 77058, United States
GSK Investigational Site
Houston, Texas, 77099, United States
GSK Investigational Site
Pharr, Texas, 78577, United States
GSK Investigational Site
Round Rock, Texas, 78681, United States
GSK Investigational Site
Sugar Land, Texas, 77479, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Renton, Washington, 98057, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Fortaleza, Ceará, 60115-282, Brazil
GSK Investigational Site
Fortaleza - CE, Ceará, 60430-350, Brazil
GSK Investigational Site
Goiânia, Goiás, 74110-010, Brazil
GSK Investigational Site
Uberlândia, Minas Gerais, 38411-186, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035001, Brazil
GSK Investigational Site
Campinas, São Paulo, 13010-001, Brazil
GSK Investigational Site
Marília, São Paulo, 17519-000, Brazil
GSK Investigational Site
Pará, 66073-000, Brazil
GSK Investigational Site
São Paulo, 01223-001, Brazil
GSK Investigational Site
São Paulo, 04038-002, Brazil
GSK Investigational Site
Penticton, British Columbia, V2A 5C8, Canada
GSK Investigational Site
Brampton, Ontario, L6S 0C9, Canada
GSK Investigational Site
Oakville, Ontario, L6M 1M1, Canada
GSK Investigational Site
Thornhill, Ontario, L4J 8L7, Canada
GSK Investigational Site
Toronto, Ontario, M4G 3E8, Canada
GSK Investigational Site
Saint-Laurent, Quebec, H4T 1Z9, Canada
GSK Investigational Site
Corbeil-Essonnes, 91106, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Valenciennes, 59322, France
GSK Investigational Site
Vandœuvre-lès-Nancy, 54501, France
GSK Investigational Site
Vénissieux, 69200, France
GSK Investigational Site
Bad Mergentheim, Baden-Wurttemberg, 97980, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69115, Germany
GSK Investigational Site
Wangen, Baden-Wurttemberg, 88239, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Sulzbach-Rosenberg, Bavaria, 92237, Germany
GSK Investigational Site
Aßlar, Hesse, 35614, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19059, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355, Germany
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Saarlouis, Saarland, 66740, Germany
GSK Investigational Site
Sankt Ingbert, Saarland, 66386, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Pirna, Saxony, 01796, Germany
GSK Investigational Site
Berlin, 10115, Germany
GSK Investigational Site
Baja, 6500, Hungary
GSK Investigational Site
Balatonfüred, 8230, Hungary
GSK Investigational Site
Budaörs, 2040, Hungary
GSK Investigational Site
Budapest, 1036, Hungary
GSK Investigational Site
Budapest, 1158, Hungary
GSK Investigational Site
Debrecen, 4031, Hungary
GSK Investigational Site
Pécs, 7643, Hungary
GSK Investigational Site
Zalaegerszeg, 8900, Hungary
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, 40138, Italy
GSK Investigational Site
Rome, Lazio, 00128, Italy
GSK Investigational Site
Milan, Lombardy, 20122, Italy
GSK Investigational Site
Milan, Lombardy, 20132, Italy
GSK Investigational Site
Pavia, Lombardy, 27100, Italy
GSK Investigational Site
Pachuca, Hidalgo, 42084, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44570, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44657, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44670, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64020, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64460, Mexico
GSK Investigational Site
Monterrey NL, Nuevo León, 64718, Mexico
GSK Investigational Site
Mérida, Yucatán, 97070, Mexico
GSK Investigational Site
Aguascalientes, 20129, Mexico
GSK Investigational Site
Aguascalientes, 20230, Mexico
GSK Investigational Site
Chihuahua City, 31217, Mexico
GSK Investigational Site
Durango, 34000, Mexico
GSK Investigational Site
Durango, 34080, Mexico
GSK Investigational Site
Guadalajara, 44600, Mexico
GSK Investigational Site
Mexico City, 03300, Mexico
GSK Investigational Site
México, 07760, Mexico
GSK Investigational Site
México, 14000, Mexico
GSK Investigational Site
Veracruz, 91020, Mexico
GSK Investigational Site
Davao City, 8000, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Marikina City, 1810, Philippines
GSK Investigational Site
Quezon City, 2000, Philippines
GSK Investigational Site
Bialystok, 15-435, Poland
GSK Investigational Site
Kamieniec Ząbkowicki, 57-230, Poland
GSK Investigational Site
Lodz, 90-132, Poland
GSK Investigational Site
Oświęcim, 32-600, Poland
GSK Investigational Site
Puławy, 24-100, Poland
GSK Investigational Site
Radom, 26-610, Poland
GSK Investigational Site
Ruda Śląska, 41-709, Poland
GSK Investigational Site
Zamość, 22-400, Poland
GSK Investigational Site
Bloemfontein, Free State, 9301, South Africa
GSK Investigational Site
Johannesburg, Gauteng, 1685, South Africa
GSK Investigational Site
Johannesburg, Gauteng, 2013, South Africa
GSK Investigational Site
Durban, KwaZulu-Natal, 4067, South Africa
GSK Investigational Site
Johannesburg, 2193, South Africa
GSK Investigational Site
Krugersdorp, 1724, South Africa
GSK Investigational Site
Worcester, 6850, South Africa
GSK Investigational Site
Gyeonggido, 420-717, South Korea
GSK Investigational Site
Seoul, 135-710, South Korea
GSK Investigational Site
A Coruña, 15006, Spain
GSK Investigational Site
Alcalá de Henares, 28805, Spain
GSK Investigational Site
Alzira/Valencia, 46600, Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barakaldo (Vizcaya), 48903, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 8041, Spain
GSK Investigational Site
Ferrol. La Coruña, 15405, Spain
GSK Investigational Site
Granada, 18012, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
León, 24071, Spain
GSK Investigational Site
Lleida, 25198, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Majadahonda, 28220, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Mérida, 6800, Spain
GSK Investigational Site
Palma de Mallorca, 07120, Spain
GSK Investigational Site
Palma de Mallorca, 07198, Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Valencia, 46014, Spain
GSK Investigational Site
Valencia, 46026, Spain
GSK Investigational Site
Welwyn Garden City, Hertfordshire, AL7 4HQ, United Kingdom
GSK Investigational Site
Bath, Somerset, BA1 3NG, United Kingdom
GSK Investigational Site
Hull, HU3 2JZ, United Kingdom
GSK Investigational Site
Lancashire, BL9 7TD, United Kingdom
GSK Investigational Site
Sidcup, DA14 6LT, United Kingdom
Related Publications (1)
Rosenstock J, Nino A, Soffer J, Erskine L, Acusta A, Dole J, Carr MC, Mallory J, Home P. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care. 2020 Oct;43(10):2509-2518. doi: 10.2337/dc19-2316. Epub 2020 Jul 21.
PMID: 32694215BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2014
First Posted
September 1, 2014
Study Start
November 21, 2014
Primary Completion
July 24, 2017
Study Completion
July 24, 2017
Last Updated
November 27, 2020
Results First Posted
June 29, 2018
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study is available via the Clinical Study Data Request site.