Clinical trial NCT02229227: Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
Official title: Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: switch study
albiglutide
glucagon-like peptide-1 receptor agonist
Type 2 diabetes mellitus
basal-bolus insulin therapy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2014-09-01
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 \[e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of Screening\])
* Hemoglobin \<11 gram (g) per (dL) \[\<110 g/L\] for male subjects and \<10 g/dL (\<100 g/L) for female subjects at Screening
* Estimated glomerular filtration rate (eGFR) \<= 30 millilitre per minute per 1.73 square meters (mL/min/1.73 m\^2) (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula) at Screening Note: As the use of metformin in subjects with varying degrees of renal function may differ from country to country, use of metformin should be in accordance with the metformin product label within the participating country.
* Fasting triglyceride level \>750 mg/dL at Screening
* Hemoglobinopathy that may affect proper interpretation of HbA1c
* Known allergy to albiglutide or any product components (including yeast and human albumin), any other GLP-1 analogue, insulin, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications (e.g., insulin glargine, insulin lispro)
* Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (\>1 week) in the 6 months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed
* Female subject is pregnant (confirmed by laboratory testing) or lactating
* Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
timeFrame: Baseline (Day -1) and Week 26
Secondary outcomes:
measure: 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
timeFrame: Up to Week 26
measure: Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26
timeFrame: Up to Week 26
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline (Day -1) and Week 26
measure: Change From Baseline to Week 26 in Body Weight
timeFrame: Baseline (Day -1) to Week 26
measure: Total Daily Insulin Dose at Week 26
timeFrame: Week 26
measure: Change From Baseline to Week 26 in HbA1c
timeFrame: Baseline to Week 26
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline to Week 26 in FPG
timeFrame: Baseline to Week 26
measure: Number of Participants Achieving HbA1c <7.0% at Week 26
timeFrame: Week 26
measure: Number of Participants Achieving HbA1c <7.0% up to Week 26
timeFrame: Up to Week 26
measure: Number of Participants Achieving a HbA1c <6.5% at Week 26
timeFrame: Week 26
measure: Number of Participants Achieving a HbA1c <6.5% up to Week 26
timeFrame: Up to Week 26
measure: Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26
timeFrame: Week 26
measure: Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26
timeFrame: Up to Week 26
measure: Total Daily Insulin Dose at Week 4, Week 10 and Week 18
timeFrame: Weeks 4, 10, and 18
measure: Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits
timeFrame: Weeks 4, 10, 18, and 26
measure: Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits
timeFrame: Weeks 4, 10, 18, and 26
measure: Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26
timeFrame: Baseline (Day -1) and Weeks 4, 10, 18 and 26
measure: Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26
timeFrame: Week 26
measure: Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication
timeFrame: Up to Week 26
measure: Number of Participants With Other AE of Special Interest
timeFrame: Up to Week 26
measure: Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26
timeFrame: Up to Week 26
measure: Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)
timeFrame: Up to Week 26
measure: Number of Participants With Daytime and Nocturnal Hypoglycemia
timeFrame: Up to Week 26
measure: Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms
timeFrame: Up to Week 26
measure: Number of Participants With Hematology Values of Clinical Concern
timeFrame: Up to 30 weeks
measure: Number of Participants With Clinical Chemistry Values of Clinical Concern
timeFrame: Up to 30 weeks
measure: Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26
timeFrame: Week 0 and Week 26
measure: Mean Albumin at Week 0 and Week 26
timeFrame: Week 0 and Week 26
measure: Mean Creatinine at Week 0 and Week 26
timeFrame: Week 0 and Week 26
measure: Mean Specific Gravity at Week 0 and Week 26
timeFrame: Week 0 and Week 26
measure: Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26
timeFrame: Week 0 and Week 26
measure: Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26
timeFrame: Week 0 and Week 26
measure: Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26
timeFrame: Week 0 and Week 26
measure: Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26
timeFrame: Baseline, Week 10 and Week 26
measure: Number of Participants With Vital Signs of Clinical Concern
timeFrame: Up to 30 weeks
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters
timeFrame: Up to 30 weeks
Other outcomes:
Locations:
city: Searcy
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Tustin
country: United States
facility: GSK Investigational Site
state: California
city: West Hills
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Brooksville
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Paducah
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Staten Island
country: United States
facility: GSK Investigational Site
state: New York
city: Shelby
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Kettering
country: United States
facility: GSK Investigational Site
state: Ohio
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Pharr
country: United States
facility: GSK Investigational Site
state: Texas
city: Round Rock
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: Renton
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Fortaleza - CE
country: Brazil
facility: GSK Investigational Site
state: Ceará
city: Fortaleza
country: Brazil
facility: GSK Investigational Site
state: Ceará
city: Goiânia
country: Brazil
facility: GSK Investigational Site
state: Goiás
city: Uberlandia
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Marília
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Pará
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Penticton
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Saint Laurent
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Corbeil-Essonnes
country: France
facility: GSK Investigational Site
city: Nantes Cedex 1
country: France
facility: GSK Investigational Site
city: Valenciennes
country: France
facility: GSK Investigational Site
city: Vandoeuvre les Nancy
country: France
facility: GSK Investigational Site
city: Venissieux
country: France
facility: GSK Investigational Site
city: Bad Mergentheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Sulzbach-Rosenberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Asslar
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Ludwigshafen am Rhein
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Saarlouis
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Sankt Ingbert
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Baja
country: Hungary
facility: GSK Investigational Site
city: Balatonfured
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budaörs
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Pecs
country: Hungary
facility: GSK Investigational Site
city: Zalaegerszeg
country: Hungary
facility: GSK Investigational Site
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pavia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Gyeonggido
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Pachuca
country: Mexico
facility: GSK Investigational Site
state: Hidalgo
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey NL
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Aguascalientes
country: Mexico
facility: GSK Investigational Site
city: Aguascalientes
country: Mexico
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Veracruz
country: Mexico
facility: GSK Investigational Site
city: Davao City
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Marikina City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Kamieniec Zabkowicki
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Oswiecim
country: Poland
facility: GSK Investigational Site
city: Pulawy
country: Poland
facility: GSK Investigational Site
city: Radom
country: Poland
facility: GSK Investigational Site
city: Ruda Slaska
country: Poland
facility: GSK Investigational Site
city: Zamosc
country: Poland
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Krugersdorp
country: South Africa
facility: GSK Investigational Site
city: Worcester
country: South Africa
facility: GSK Investigational Site
city: Alcala de Henares
country: Spain
facility: GSK Investigational Site
city: Alzira/Valencia
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barakaldo (Vizcaya)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Ferrol. La Coruña
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: León
country: Spain
facility: GSK Investigational Site
city: Lleida
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Merida
country: Spain
facility: GSK Investigational Site
city: Málaga
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Welwyn Garden City
country: United Kingdom
facility: GSK Investigational Site
state: Hertfordshire
city: Bath
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: Lancashire
country: United Kingdom
facility: GSK Investigational Site
city: Sidcup
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.