Clinical trial NCT00313313: A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
Official title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 768
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 trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes.
* Treated with a sulfonylurea for at least 2 months.
* Inadequate blood sugar control.
* Are not on any other medications to lower blood sugar.
* No major heart, liver or kidney problems.
* Women not pregnant or breast feeding.

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: Jonesboro
country: United States
facility: Reserach Solutions, Llc
state: Arkansas
city: Searcy
country: United States
facility: Searcy Medical Center
state: Arkansas
city: Alhambra
country: United States
facility: Stewart Medical Group
state: California
city: Fountain Valley
country: United States
facility: Southland Clinical Research Center, Inc.
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Los Angeles
country: United States
facility: Randall Shue, D.O.
state: California
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: Golden
country: United States
facility: New West Physicians
state: Colorado
city: Waterbury
country: United States
facility: Phoenix Internal Medicine Associates, Llc
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Research Institute
state: Delaware
city: Altamonte Springs
country: United States
facility: Central Florida Clinical Trials
state: Florida
city: Chipley
country: United States
facility: Family Care Assoc & Emerald Care Res Grp
state: Florida
city: Coral Gables
country: United States
facility: Clinical Therapeutics Corporation
state: Florida
city: Kissimmee
country: United States
facility: Fpa Clinical Research
state: Florida
city: Marianna
country: United States
facility: Emerald Coast Research Group
state: Florida
city: Miami
country: United States
facility: University Of Miami Diabetes Research Inst.
state: Florida
city: Dunwoody
country: United States
facility: Atlanta Pharmaceutical Research Center, Inc
state: Georgia
city: Chicago
country: United States
facility: Cedar-Crosse Research Ctr
state: Illinois
city: Munfordville
country: United States
facility: Family Medical Center Of Hart Co.
state: Kentucky
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Kansas City
country: United States
facility: Va Medical Center
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Center For Clinical Research
state: Missouri
city: North Las Vegas
country: United States
facility: Nevada Alliance Against Diabetes
state: Nevada
city: Toms River
country: United States
facility: Physicians Research Center
state: New Jersey
city: East Syracuse
country: United States
facility: Cny Family Care
state: New York
city: Charlotte
country: United States
facility: Metrolina Internal Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Med Res Assoc Charlotte
state: North Carolina
city: High Point
country: United States
facility: Regional Physicians Research
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants, Pc
state: North Carolina
city: Sparta
country: United States
facility: Mountain Top Clinical Research Center
state: North Carolina
city: Akron
country: United States
facility: Daystar Clinical Research, Inc.
state: Ohio
city: Canal Fulton
country: United States
facility: Community Health Care
state: Ohio
city: Franklin
country: United States
facility: Triphase Research, Ltd.
state: Ohio
city: Mason
country: United States
facility: Albert J Weisbrot,Md&Assoc Inc
state: Ohio
city: Youngstown
country: United States
facility: Dr Bahagwan Dass Md
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular And Hypertension Center
state: Oklahoma
city: Tulsa
country: United States
facility: Utica Park Clinic
state: Oklahoma
city: Yukon
country: United States
facility: Integris Family Care Yukon
state: Oklahoma
city: Eugene
country: United States
facility: Coordinators Plus, Llc
state: Oregon
city: Portland
country: United States
facility: Oregon Clinical Research
state: Oregon
city: Norristown
country: United States
facility: Pearl Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Banksville Medical Pc
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic, Ltd
state: Pennsylvania
city: Simsonville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Taylors
country: United States
facility: Southeastern Research Assoc
state: South Carolina
city: Austin
country: United States
facility: Capital Medical Clinic, Llp
state: Texas
city: Houston
country: United States
facility: Texas Center For Drug Development, P.A.
state: Texas
city: Katy
country: United States
facility: Breath Of Life Research Institute
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc, Pa
state: Texas
city: San Antonio
country: United States
facility: S.A.M. Clinical Research Center
state: Texas
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Spokane
country: United States
facility: Office Of Dr. Gray
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare S.C.
state: Wisconsin
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: B. Rodolfo Teofilo
country: Brazil
facility: Local Institution
state: Ceara
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Belem
country: Brazil
facility: Local Institution
state: Para
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Marília
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo - Sp
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Vila Mariana
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Kowloon
country: Hong Kong
facility: Local Institution
city: Givatayim
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Holon
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Rishon Le-Zion
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Zefat
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Kyunggi-Do
country: Korea, Republic of
facility: Local Institution
city: Kyunggi-Do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution
city: Tijuana, B.C.
country: Mexico
facility: Local Institution
state: Baja California
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Durango
country: Mexico
facility: Local Institution
city: San Isidro
country: Peru
facility: Local Institution
state: Lima
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Cebu
country: Philippines
facility: Local Institution
city: Manila
country: Philippines
facility: Local Institution
city: Quezon
country: Philippines
facility: Local Institution
city: Carolina
country: Puerto Rico
facility: Local Institution
city: Guaynabo
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Umhlanga Rocks
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Kimberley
country: South Africa
facility: Local Institution
state: Northern Cape
city: Tygerberg
country: South Africa
facility: Local Institution
state: Western Cape
city: Cape Town
country: South Africa
facility: Local Institution
city: Johannesburg
country: South Africa
facility: Local Institution
city: Changhua
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
References:
citation: Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R; CV181-040 Investigators. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract. 2009 Sep;63(9):1395-406. doi: 10.1111/j.1742-1241.2009.02143.x. Epub 2009 Jul 15.
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: Chacra AR, Tan GH, Ravichandran S, List J, Chen R; CV181040 Investigators. Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. Diab Vasc Dis Res. 2011 Apr;8(2):150-9. doi: 10.1177/1479164111404574.