Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Moscov, Den Russiske Føderation, 118089
- Local Institution
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Moscow, Den Russiske Føderation, 115487
- Local Institution
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Nizhniy Novgorod, Den Russiske Føderation, 603126
- Local Institution
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Saint Petersburg, Den Russiske Føderation, 198013
- Local Institution
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Saratov, Den Russiske Føderation, 410018
- Local Institution
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Saratov, Den Russiske Føderation, 410054
- Local Institution
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Smolensk, Den Russiske Føderation, 214018
- Local Institution
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St.Petersburg, Den Russiske Føderation, 194156
- Local Institution
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Volgograd, Den Russiske Føderation, 400138
- Local Institution
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Alabama
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Columbiana, Alabama, Forenede Stater, 35051
- Tomac, Inc.
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Haleyville, Alabama, Forenede Stater, 35565
- Winston Technology, Inc.
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Arizona
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Mesa, Arizona, Forenede Stater, 85213
- Clinical Reseacrh Advantage/ Brown Family Medicine
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California
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Bakersfield, California, Forenede Stater, 93311
- Strategos Medical Group
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Burbank, California, Forenede Stater, 91505
- Providence Clinical Research
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Cudahy, California, Forenede Stater, 90201
- Rx for Life, Inc
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Encino, California, Forenede Stater, 91436
- Medical Group of Encino
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Fountain Valley, California, Forenede Stater, 92708
- Southland Clinical Research Center, Inc.
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Fresno, California, Forenede Stater, 93720
- Valley Research
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Northridge, California, Forenede Stater, 91325
- Diabetes Medical Center Of California
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Pico Rivera, California, Forenede Stater, 90660
- In Private Prictice Clinic
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San Jose, California, Forenede Stater, 95128
- San Jose Clinical Research, Inc.
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Florida
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Altamonte Springs, Florida, Forenede Stater, 32714
- Central Florida Clinical Trials, Inc.
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Melbourne, Florida, Forenede Stater, 32935
- Accelovance
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Sarasota, Florida, Forenede Stater, 34243
- University Family Healthcare, Pa
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St. Petersburg, Florida, Forenede Stater, 33707
- Premier Healthcare
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Kansas
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Overland Park, Kansas, Forenede Stater, 66215
- Pinnacle Medical Research
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Missouri
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Kansas City, Missouri, Forenede Stater, 64106
- Kansas City University Of Medicine And Biosciences
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Wentzville, Missouri, Forenede Stater, 63385
- Primary Care Physicians, Pc
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New Jersey
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Toms River, New Jersey, Forenede Stater, 08755
- Physicians Research Center
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New York
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Kingston, New York, Forenede Stater, 12401
- Hudson Valley Clinical Research Center
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28262
- Neem Research Group of Charlotte
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Greenville, North Carolina, Forenede Stater, 27834
- Diabetes Center- East Carolina University
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Salisbury, North Carolina, Forenede Stater, 28144
- Crescent Medical Research
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Ohio
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Barberton, Ohio, Forenede Stater, 44203
- Community Health Care, Inc.
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Canton, Ohio, Forenede Stater, 44718
- Clinical Research Limited
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Kettering, Ohio, Forenede Stater, 45429
- Wells Institute for Health Awareness
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Perrysburg, Ohio, Forenede Stater, 43551
- Clinical Research Source, Inc
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Accelovance
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Oklahoma City, Oklahoma, Forenede Stater, 73170
- Integris Family Care South
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Oregon
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Eugene, Oregon, Forenede Stater, 97404
- The Office Of Patricia Buchanan
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Pennsylvania
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Carlisle, Pennsylvania, Forenede Stater, 17015
- Cumberland Valley Endocrinology Center, Llc
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Fleetwood, Pennsylvania, Forenede Stater, 19522
- Fleetwood Clinical Research
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Pittsburgh, Pennsylvania, Forenede Stater, 15216
- Banksville Medical, Pc
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Shippensburg, Pennsylvania, Forenede Stater, 17257
- Biomedical Research Associates, Llc
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South Carolina
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Duncan, South Carolina, Forenede Stater, 29334
- Middle Tyger Family Medicine
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Taylors, South Carolina, Forenede Stater, 29687
- Southeastern Research Assoc
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Tennessee
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Bartlett, Tennessee, Forenede Stater, 38134
- Versoza & Ungab Internal Medicine Associates
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Collierville, Tennessee, Forenede Stater, 38017
- Collierville Medical Specialist
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Kingsport, Tennessee, Forenede Stater, 37660
- Holston Medical Group
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Memphis, Tennessee, Forenede Stater, 38116
- Med-South Research
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Memphis, Tennessee, Forenede Stater, 38125
- Southwind Medical Specialist
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Texas
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Carrollton, Texas, Forenede Stater, 75010
- Precision Family Medicine
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Corpus Christi, Texas, Forenede Stater, 78411
- Alpha Therapy Research Center
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Houston, Texas, Forenede Stater, 77081
- Texas Center For Drug Development, P.A.
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Houston, Texas, Forenede Stater, 77024
- Village Family Practice
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San Antonio, Texas, Forenede Stater, 78224
- Abbott Clinical Research Group, Inc
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Taylor/Wade Medical
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Salt Lake City, Utah, Forenede Stater, 84102
- Optimum Clinical Research
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23451
- Tidewater Integrated Medical Research
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Washington
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Spokane, Washington, Forenede Stater, 99216
- Spokane Internal Medicine
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Bangalore, Indien, 560034
- Local Institution
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Mumbai, Indien, 400007
- Local Institution
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Mumbai, Indien, 400021
- Local Institution
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Nagpur, Indien, 440012
- Local Institution
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Karnataka
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Manipal, Karnataka, Indien, 576104
- Local Institution
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Kerala
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Kochi, Kerala, Indien, 682026
- Local Institution
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Mangalore
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Attavar, Mangalore, Indien, 575001
- Local Institution
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New Delhi
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Sarita Vihar, New Delhi, Indien, 110076
- Local Institution
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Changhua, Taiwan, 500
- Local Institution
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Kaohsiung County, Taiwan, 833
- Local Institution
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Taichung, Taiwan, 402
- Local Institution
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Taichung City, Taiwan, 407
- Local Institution
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Taipei City, Taiwan, 114
- Local Institution
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Tao-Yuan County, Taiwan, 333
- Local Institution
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
|
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Eksperimentel: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
|
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Eksperimentel: Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
|
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Eksperimentel: Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
|
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Placebo komparator: Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
|
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Tidsramme: Baseline, Week 24
|
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
|
Baseline, Week 24
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Tidsramme: Baseline, Week 24
|
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
|
Baseline, Week 24
|
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Ændring fra baseline i fastende plasmaglukose (FPG) i uge 24
Tidsramme: Baseline, uge 24
|
Gennemsnitlig ændring fra baseline i FPG i uge 24, justeret for basislinjeværdi.
|
Baseline, uge 24
|
|
Percentage of Participants Achieving A1C < 7% at Week 24
Tidsramme: Week 24
|
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
|
Week 24
|
|
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Tidsramme: Baseline, Week 24
|
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
|
Baseline, Week 24
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Metformin
- Saxagliptin
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CV181-038
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