Clinical trial NCT01098539: A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
Official title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: sitagliptin
albiglutide
renal impairment
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 507
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 randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Detailed description: This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Eligibility criteria: Inclusion Criteria:

* Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
* BMI \>/=20 kg/m2 and \</=45 kg/m2
* Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L)
* HbA1c between 7.0% and 10.0%, inclusive.

Exclusion Criteria:

* History of cancer
* History of treated diabetic gastroparesis
* Current biliary disease or history of pancreatitis
* History of significant gastrointestinal surgery
* Recent clinically significant cardiovascular and/or cerebrovascular disease
* History of human immunodeficiency virus infection
* Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
* Female subject is pregnant (confirmed by laboratory testing), lactating, or \<6 weeks postpartum
* Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
* Receipt of any investigational drug or sitagliptin 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
timeFrame: Baseline; Week 26
Secondary outcomes:
measure: Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
timeFrame: Baseline; Weeks 4, 8, 12, 16, and 20
measure: Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases
timeFrame: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Baseline; Week 26
measure: Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
timeFrame: Baseline; Weeks 4, 8, 12, 16, 20, and 26
measure: Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC
timeFrame: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
measure: Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF
timeFrame: Week 26
measure: Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF
timeFrame: Week 26
measure: Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC
timeFrame: Week 52
measure: Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC
timeFrame: Week 52
measure: Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52
timeFrame: Week 2 to Week 52
measure: Time to Hyperglycemic Rescue Through Week 52
timeFrame: Week 2 to Week 52
measure: Change From Baseline in Body Weight at Week 26: LOCF
timeFrame: Baseline; Week 26
measure: Change From Baseline in Body Weight Through Week 26: LOCF
timeFrame: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26
measure: Change From Baseline in Body Weight Through Week 52: OC
timeFrame: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52
measure: Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16
timeFrame: Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Gulf Shores
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Toney
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Gatos
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Dimas
country: United States
facility: GSK Investigational Site
state: California
city: Tarzana
country: United States
facility: GSK Investigational Site
state: California
city: West Hills
country: United States
facility: GSK Investigational Site
state: California
city: Whittier
country: United States
facility: GSK Investigational Site
state: California
city: Whittier
country: United States
facility: GSK Investigational Site
state: California
city: Doral
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Blue Ridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Roswell
country: United States
facility: GSK Investigational Site
state: Georgia
city: Stone Mountain
country: United States
facility: GSK Investigational Site
state: Georgia
city: Valparaiso
country: United States
facility: GSK Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Mission
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Paducah
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Alexandria
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Bangor
country: United States
facility: GSK Investigational Site
state: Maine
city: Hyattsville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Springfield
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Dearborn
country: United States
facility: GSK Investigational Site
state: Michigan
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Flint
country: United States
facility: GSK Investigational Site
state: Michigan
city: St Clair Shores
country: United States
facility: GSK Investigational Site
state: Michigan
city: Taylor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: North Massapequa
country: United States
facility: GSK Investigational Site
state: New York
city: Staten Island
country: United States
facility: GSK Investigational Site
state: New York
city: Asheville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Hurst
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Tabor City
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Gallipolis
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Altoona
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Downington
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: North Myrtle Beach
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Taylors
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Franklin
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Tullahoma
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: GSK Investigational Site
state: Texas
city: Arlington
country: United States
facility: GSK Investigational Site
state: Texas
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: Dallas
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Deer Park
country: United States
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state: Texas
city: Fort Worth
country: United States
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state: Texas
city: Grapevine
country: United States
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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: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
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state: Texas
city: Houston
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Humble
country: United States
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state: Texas
city: Hurst
country: United States
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state: Texas
city: Irving
country: United States
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state: Texas
city: Midland
country: United States
facility: GSK Investigational Site
state: Texas
city: North Richland Hills
country: United States
facility: GSK Investigational Site
state: Texas
city: Pearland
country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: Richardson
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
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state: Texas
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country: United States
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state: Texas
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country: United States
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country: United States
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state: Texas
city: Bountiful
country: United States
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state: Utah
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Burke
country: United States
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state: Virginia
city: Manassas
country: United States
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state: Virginia
city: Norfolk
country: United States
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state: Virginia
city: Salem
country: United States
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state: Virginia
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Garran
country: Australia
facility: GSK Investigational Site
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Caboolture
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Brasília
country: Brazil
facility: GSK Investigational Site
city: Mogi das Cruzes
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Barrangquilla
country: Colombia
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Floridablanca-Santander
country: Colombia
facility: GSK Investigational Site
city: Bad Nauheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Bad Lauterberg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Belgaum,
country: India
facility: GSK Investigational Site
city: Belgaum
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: Manipal
country: India
facility: GSK Investigational Site
city: Mumbai
country: India
facility: GSK Investigational Site
city: Nasik
country: India
facility: GSK Investigational Site
city: Ashkelon
country: Israel
facility: GSK Investigational Site
city: Beer-Sheva
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Holon
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Safed
country: Israel
facility: GSK Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon, Kyonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Callao
country: Peru
facility: GSK Investigational Site
state: Lima
city: Arequipa
country: Peru
facility: GSK Investigational Site
city: Ica
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Piura
country: Peru
facility: GSK Investigational Site
city: Trujillo
country: Peru
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Makati City
country: Philippines
facility: GSK Investigational Site
city: Pasay
country: Philippines
facility: GSK Investigational Site
city: Tagbilaran City
country: Philippines
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Lenasia
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Phoenix
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Houghton
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Tygerberg
country: South Africa
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: La Coruña
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: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Torrevieja (Alicante)
country: Spain
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Hertfordshire
country: United Kingdom
facility: GSK Investigational Site
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Livingston
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Plymouth
country: United Kingdom
facility: GSK Investigational Site
city: Swansea
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.