Clinical trial NCT00316082: Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 365
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 saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

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 (rescue medication) added onto their blinded study medication

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Inadequate blood sugar control

Exclusion Criteria:

* Previous treatment for diabetes
* Current treatment with other medications to lower blood sugar
* Major heart, liver or kidney problems
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1 (A1C) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
timeFrame: Baseline, Week 24
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: Columbiana
country: United States
facility: Tomac, Inc.
state: Alabama
city: Haleyville
country: United States
facility: Winston Technology, Inc.
state: Alabama
city: Mesa
country: United States
facility: Clinical Reseacrh Advantage/ Brown Family Medicine
state: Arizona
city: Bakersfield
country: United States
facility: Strategos Medical Group
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Cudahy
country: United States
facility: Rx For Life, Inc
state: California
city: Encino
country: United States
facility: Medical Group Of Encino
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: Northridge
country: United States
facility: Diabetes Medical Center Of California
state: California
city: Pico Rivera
country: United States
facility: In Private Prictice Clinic
state: California
city: San Jose
country: United States
facility: San Jose Clinical Research, Inc.
state: California
city: Altamonte Springs
country: United States
facility: Central Florida Clinical Trials, Inc.
state: Florida
city: Melbourne
country: United States
facility: Accelovance
state: Florida
city: Sarasota
country: United States
facility: University Family Healthcare, Pa
state: Florida
city: St. Petersburg
country: United States
facility: Premier Healthcare
state: Florida
city: Overland Park
country: United States
facility: Pinnacle Medical Research
state: Kansas
city: Kansas City
country: United States
facility: Kansas City University Of Medicine And Biosciences
state: Missouri
city: Wentzville
country: United States
facility: Primary Care Physicians, Pc
state: Missouri
city: Toms River
country: United States
facility: Physicians Research Center
state: New Jersey
city: Kingston
country: United States
facility: Hudson Valley Clinical Research Center
state: New York
city: Charlotte
country: United States
facility: Neem Research Group Of Charlotte
state: North Carolina
city: Greenville
country: United States
facility: Diabetes Center- East Carolina University
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Barberton
country: United States
facility: Community Health Care, Inc.
state: Ohio
city: Canton
country: United States
facility: Clinical Research Limited
state: Ohio
city: Kettering
country: United States
facility: Wells Institute For Health Awareness
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Accelovance
state: Oklahoma
city: Oklahoma City
country: United States
facility: Integris Family Care South
state: Oklahoma
city: Eugene
country: United States
facility: The Office Of Patricia Buchanan
state: Oregon
city: Carlisle
country: United States
facility: Cumberland Valley Endocrinology Center, Llc
state: Pennsylvania
city: Fleetwood
country: United States
facility: Fleetwood Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Banksville Medical, Pc
state: Pennsylvania
city: Shippensburg
country: United States
facility: Biomedical Research Associates, Llc
state: Pennsylvania
city: Duncan
country: United States
facility: Middle Tyger Family Medicine
state: South Carolina
city: Taylors
country: United States
facility: Southeastern Research Assoc
state: South Carolina
city: Bartlett
country: United States
facility: Versoza & Ungab Internal Medicine Associates
state: Tennessee
city: Collierville
country: United States
facility: Collierville Medical Specialist
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Med-South Research
state: Tennessee
city: Memphis
country: United States
facility: Southwind Medical Specialist
state: Tennessee
city: Carrollton
country: United States
facility: Precision Family Medicine
state: Texas
city: Corpus Christi
country: United States
facility: Alpha Therapy Research Center
state: Texas
city: Houston
country: United States
facility: Village Family Practice
state: Texas
city: Houston
country: United States
facility: Texas Center For Drug Development, P.A.
state: Texas
city: San Antonio
country: United States
facility: Abbott Clinical Research Group, Inc
state: Texas
city: Bountiful
country: United States
facility: Taylor/Wade Medical
state: Utah
city: Salt Lake City
country: United States
facility: Optimum Clinical Research
state: Utah
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Spokane
country: United States
facility: Spokane Internal Medicine
state: Washington
city: Manipal
country: India
facility: Local Institution
state: Karnataka
city: Kochi
country: India
facility: Local Institution
state: Kerala
city: Attavar
country: India
facility: Local Institution
state: Mangalore
city: Sarita Vihar
country: India
facility: Local Institution
state: New Delhi
city: Bangalore
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Nagpur
country: India
facility: Local Institution
city: Moscov
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Nizhniy Novgorod
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: Volgograd
country: Russian Federation
facility: Local Institution
city: Changhua
country: Taiwan
facility: Local Institution
city: Kaohsiung County
country: Taiwan
facility: Local Institution
city: Taichung City
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei City
country: Taiwan
facility: Local Institution
city: Tao-Yuan County
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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: Frederich R, McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.