A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

NCT ID: NCT01098539

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 507 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-11-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

albiglutide

albiglutide weekly subcutaneous injection + sitagliptin matching placebo

Group Type: ACTIVE_COMPARATOR

albiglutide

Intervention Type: BIOLOGICAL

albiglutide weekly subcutaneous injection + sitagliptin matching placebo

sitagliptin

albiglutide matching placebo + sitagliptin

Group Type: ACTIVE_COMPARATOR

sitagliptin

Intervention Type: DRUG

albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

Interventions

albiglutide

albiglutide weekly subcutaneous injection + sitagliptin matching placebo

Intervention Type: BIOLOGICAL

sitagliptin

albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Gulf Shores, Alabama, United States

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Toney, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

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Fresno, California, United States

GSK Investigational Site

Huntington Beach, California, United States

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Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

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Los Angeles, California, United States

GSK Investigational Site

Los Gatos, California, United States

GSK Investigational Site

Orange, California, United States

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San Diego, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Dimas, California, United States

GSK Investigational Site

Tarzana, California, United States

GSK Investigational Site

West Hills, California, United States

GSK Investigational Site

Whittier, California, United States

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Whittier, California, United States

GSK Investigational Site

Doral, Florida, United States

GSK Investigational Site

Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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New Port Richey, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Blue Ridge, Georgia, United States

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Decatur, Georgia, United States

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Roswell, Georgia, United States

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Stone Mountain, Georgia, United States

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Valparaiso, Indiana, United States

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Des Moines, Iowa, United States

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Mission, Kansas, United States

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Lexington, Kentucky, United States

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Paducah, Kentucky, United States

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Alexandria, Louisiana, United States

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Bangor, Maine, United States

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Hyattsville, Maryland, United States

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Springfield, Massachusetts, United States

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Dearborn, Michigan, United States

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Detroit, Michigan, United States

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Flint, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Taylor, Michigan, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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North Massapequa, New York, United States

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Staten Island, New York, United States

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Asheville, North Carolina, United States

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Hurst, North Carolina, United States

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Shelby, North Carolina, United States

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Tabor City, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Gallipolis, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Altoona, Pennsylvania, United States

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Downington, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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North Myrtle Beach, South Carolina, United States

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Taylors, South Carolina, United States

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Bristol, Tennessee, United States

GSK Investigational Site

Franklin, Tennessee, United States

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Knoxville, Tennessee, United States

GSK Investigational Site

Tullahoma, Tennessee, United States

GSK Investigational Site

Arlington, Texas, United States

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Arlington, Texas, United States

GSK Investigational Site

Austin, Texas, United States

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Austin, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Deer Park, Texas, United States

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Fort Worth, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

GSK Investigational Site

Humble, Texas, United States

GSK Investigational Site

Hurst, Texas, United States

GSK Investigational Site

Irving, Texas, United States

GSK Investigational Site

Midland, Texas, United States

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North Richland Hills, Texas, United States

GSK Investigational Site

Pearland, Texas, United States

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Plano, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Schertz, Texas, United States

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Sugarland, Texas, United States

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Tomball, Texas, United States

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Bountiful, Utah, United States

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South Burlington, Vermont, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Norfolk, Virginia, United States

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Salem, Virginia, United States

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Tacoma, Washington, United States

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Garran, Australian Capital Territory, Australia

GSK Investigational Site

Camperdown, New South Wales, Australia

GSK Investigational Site

Auchenflower, Queensland, Australia

GSK Investigational Site

Caboolture, Queensland, Australia

GSK Investigational Site

Herston, Queensland, Australia

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Kippa-Ring, Queensland, Australia

GSK Investigational Site

Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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Heidelberg, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Fremantle, Western Australia, Australia

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

São Paulo, São Paulo, Brazil

GSK Investigational Site

Brasília, , Brazil

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Mogi das Cruzes, , Brazil

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Barrangquilla, , Colombia

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Bogotá, , Colombia

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Floridablanca-Santander, , Colombia

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Bad Nauheim, Hesse, Germany

GSK Investigational Site

Bad Lauterberg im Harz, Lower Saxony, Germany

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Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

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Berlin, State of Berlin, Germany

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Ahmedabad, , India

GSK Investigational Site

Bangalore, , India

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Bangalore, , India

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Bangalore, , India

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Bangalore, , India

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Bangalore, , India

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Belagavi, , India

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Belagavi, , India

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Chennai, , India

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Lucknow, , India

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Manipal, , India

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Mumbai, , India

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Nashik, , India

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Ashkelon, , Israel

GSK Investigational Site

Beersheba, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Holon, , Israel

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Kfar Saba, , Israel

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Safed, , Israel

GSK Investigational Site

Arequipa, Arequipa, Peru

GSK Investigational Site

Ica, Ica, Peru

GSK Investigational Site

Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Callao, Lima, Peru

GSK Investigational Site

Piura, Piura, Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Trujillo, , Peru

GSK Investigational Site

Cebu City, , Philippines

GSK Investigational Site

Iloilo City, , Philippines

GSK Investigational Site

Makati City, , Philippines

GSK Investigational Site

Pasay, , Philippines

GSK Investigational Site

Tagbilaran City, , Philippines

GSK Investigational Site

Nizhny Novgorod, , Russia

GSK Investigational Site

Saratov, , Russia

GSK Investigational Site

St'Petersburg, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Port Elizabeth, Eastern Cape, South Africa

GSK Investigational Site

Johannesburg, Gauteng, South Africa

GSK Investigational Site

Johannesburg, Gauteng, South Africa

GSK Investigational Site

Lenasia, Gauteng, South Africa

GSK Investigational Site

Pretoria, Gauteng, South Africa

GSK Investigational Site

Durban, KwaZulu-Natal, South Africa

GSK Investigational Site

Phoenix, KwaZulu-Natal, South Africa

GSK Investigational Site

Houghton Estate, , South Africa

GSK Investigational Site

Pretoria, , South Africa

GSK Investigational Site

Somerset West, , South Africa

GSK Investigational Site

Tygerberg, , South Africa

GSK Investigational Site

Seongnam-si, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon, Kyonggi-do, , South Korea

GSK Investigational Site

A Coruña, , Spain

GSK Investigational Site

Alicante, , Spain

GSK Investigational Site

Málaga, , Spain

GSK Investigational Site

Palma de Mallorca, , Spain

GSK Investigational Site

Santiago de Compostela, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Torrevieja (Alicante), , Spain

GSK Investigational Site

Kaohsiung City, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Tainan City, , Taiwan

GSK Investigational Site

Coventry, West Midlands, United Kingdom

GSK Investigational Site

Birmingham, , United Kingdom

GSK Investigational Site

Hertfordshire, , United Kingdom

GSK Investigational Site

Hull, , United Kingdom

GSK Investigational Site

Liverpool, , United Kingdom

GSK Investigational Site

Livingston, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Plymouth, , United Kingdom

GSK Investigational Site

Swansea, , United Kingdom

Countries

United States; Australia; Brazil; Colombia; Germany; India; Israel; Peru; Philippines; Russia; South Africa; South Korea; Spain; Taiwan; United Kingdom

References

Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

Reference Type: DERIVED

PMID: 39963952 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25387217 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

114130

Identifier Type: -

Identifier Source: org_study_id