Clinical trial NCT00295633: A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

Detailed description: All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) added onto their blinded study medication

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
* Hemoglobin A1c (HbA1c) \> = 7.0% and \< = 10.5%
* Body mass index \< = 45kg/m2
* Fasting C-peptide \> = 1 ng/mL

Exclusion Criteria:

* Symptomatic poorly controlled diabetes
* Recent cardiac or cerebrovascular event
* Serum creatinine \> = 2.0 mg/dL

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (A1C) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving A1c <7% at Week 24
timeFrame: Week 24
measure: Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Haleyville
country: United States
facility: Winston Technology, Inc.
state: Alabama
city: Mobile
country: United States
facility: Sunbelt Research Group, Llc
state: Alabama
city: Ozark
country: United States
facility: Iicr, Inc.
state: Alabama
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc
state: Arizona
city: Jonesboro
country: United States
facility: Nea Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Family Practice Clinic
state: Arkansas
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: Encino
country: United States
facility: Medical Group Of Encino
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care And Research, Inc.
state: California
city: Huntington Park
country: United States
facility: Del Rosario Medical Clinic, Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda Va Healthcare Systems
state: California
city: Los Angeles
country: United States
facility: Peak Health Medical Group
state: California
city: Los Gatos
country: United States
facility: Richard Cherlin, Md
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Denver
country: United States
facility: Denver Internal Medicine Group
state: Colorado
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Waterbury
country: United States
facility: Phoenix Internal Medicine Associates, Llc
state: Connecticut
city: Altamonte Springs
country: United States
facility: Central Florida Clinical Trials, Inc.
state: Florida
city: Chipley
country: United States
facility: Southern Family Healthcare, Pa
state: Florida
city: Defuniak Springs
country: United States
facility: Doctors Medical Center Of Walton County
state: Florida
city: Hollywood
country: United States
facility: Horizon Institute For Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Marianna
country: United States
facility: Panhandle Family Care Associates
state: Florida
city: Miami
country: United States
facility: Nextphase Clinical Trials, Inc
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates
state: Florida
city: Sarasota
country: United States
facility: Heart & Vascular Center Research, Inc.
state: Florida
city: Dunwoody
country: United States
facility: Alan B. Miller, Md
state: Georgia
city: Marietta
country: United States
facility: Marietta Clinical Research, Inc.
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Kahului
country: United States
facility: D. Thomas Rogers, Md, Facs
state: Hawaii
city: Idaho Falls
country: United States
facility: Southeast Idaho Family Practice
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Physicians Research Group
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center For Clinical Research
state: Indiana
city: Iowa City
country: United States
facility: Lipid Research Clinic
state: Iowa
city: Wichita
country: United States
facility: Professional Research Network Of Kansas
state: Kansas
city: West Monroe
country: United States
facility: Mouhaffel, Assad H.
state: Louisiana
city: Portage
country: United States
facility: Promed Physicians Family Practice
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: Radiant Research Las Vegas
state: Nevada
city: North Las Vegas
country: United States
facility: Nevada Alliance Against Diabetes
state: Nevada
city: Holmdel
country: United States
facility: Office Of Ammar Bazerbashi, Md
state: New Jersey
city: South Bound Brook
country: United States
facility: Urgentmed, P.C.
state: New Jersey
city: Charlotte
country: United States
facility: Medical Research Associates Of Charlotte, Inc.
state: North Carolina
city: Statesville
country: United States
facility: Carolina Pharmaceutical Research
state: North Carolina
city: Canal Fulton
country: United States
facility: Community Health Care
state: Ohio
city: Canton
country: United States
facility: Clinical Research Limited
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center For Clinical Research
state: Ohio
city: Gallipolis
country: United States
facility: Holzer Clinic
state: Ohio
city: Kettering
country: United States
facility: Wells Institute For Health Awareness
state: Ohio
city: Eugene
country: United States
facility: David Witkin, Md
state: Oregon
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Banksville Medical Pc
state: Pennsylvania
city: Columbia
country: United States
facility: Three Rivers Medical Associates, Pa
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Greer
state: South Carolina
city: Simpsonville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Alcoa
country: United States
facility: East Tennessee Medical Group
state: Tennessee
city: Morristown
country: United States
facility: Healthstar Physicians
state: Tennessee
city: Nashville
country: United States
facility: Hayes Endocrine And Diabetes Center
state: Tennessee
city: Austin
country: United States
facility: Capital Medical Clinic, Llp
state: Texas
city: Austin
country: United States
facility: Texas Diabetes And Endocrinology, P.A.
state: Texas
city: Austin
country: United States
facility: Radiant Research-Austin
state: Texas
city: Dallas
country: United States
facility: Priscilla Hollander, Md, Phd
state: Texas
city: Fort Worth
country: United States
facility: The Medical Group Of Texas
state: Texas
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
city: Houston
country: United States
facility: Family Physician, Pa
state: Texas
city: Houston
country: United States
facility: Mapleridge Medical Center
state: Texas
city: Midland
country: United States
facility: Diabetes Center Of The Southwest
state: Texas
city: Pearland
country: United States
facility: Pearland Primary Care Associates, Llp
state: Texas
city: Rosenberg
country: United States
facility: Med-Cure
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio
state: Texas
city: San Antonio
country: United States
facility: S.A.M. Clinical Research Center
state: Texas
city: Texarkana
country: United States
facility: Collom And Carney Clinic
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Belgrano
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Chacabuco
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Auton.
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Moron
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad De Mendoza
country: Argentina
facility: Local Institution
state: Mendoza
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Lanus Este
country: Argentina
facility: Local Institution
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: St. Johns
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Sarnia
country: Canada
facility: Local Institution
state: Ontario
city: St Catharines
country: Canada
facility: Local Institution
state: Ontario
city: St-Leonard
country: Canada
facility: Local Institution
state: Quebec
city: Ste-Foy
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Bangalore
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Hariyana
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Indore
country: India
facility: Local Institution
city: Maharashtra
country: India
facility: Local Institution
city: Mangalore
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Vellore
country: India
facility: Local Institution
city: Chichuahua
country: Mexico
facility: Local Institution
state: Chihuahua
city: Angeles Del Pedregal
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Michoacan
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Cercado De Lima
country: Peru
facility: Local Institution
state: Lima
city: La Victoria
country: Peru
facility: Local Institution
state: Lima
city: Miraflores
country: Peru
facility: Local Institution
state: Lima
city: San Isidro
country: Peru
facility: Local Institution
state: Lima
city: San Martin De Porres
country: Peru
facility: Local Institution
state: Lima
city: Santiago De Surco
country: Peru
facility: Local Institution
state: Lima
city: Cebu City
country: Philippines
facility: Local Institution
city: Cebu City
country: Philippines
facility: Local Institution
city: Iloilo City
country: Philippines
facility: Local Institution
city: Las Pinas
country: Philippines
facility: Local Institution
city: Pasig City
country: Philippines
facility: Local Institution
city: Carolina
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Rio Piedras
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. doi: 10.1210/jc.2009-0550. Epub 2009 Oct 28.
citation: Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
citation: Bonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.
citation: Karyekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.
citation: Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.
citation: Hollander PL, Li J, Frederich R, Allen E, Chen R; CV181013 Investigators. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2011 Apr;8(2):125-35. doi: 10.1177/1479164111404575.