- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00528879
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
30. september 2015 oppdatert av: AstraZeneca
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone.
The safety of this treatment will also be studied.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
915
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Buenos Aires, Argentina, 1431
- Local Institution
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Cordoba, Argentina, 5000
- Local Institution
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, 1034
- Local Institution
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Capital Federal, Buenos Aires, Argentina, 1429
- Local Institution
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Capital Federal, Buenos Aires, Argentina, C1056ABJ
- Local Institution
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Capital Federal, Buenos Aires, Argentina, C1425AGC
- Local Institution
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Ciudad Auton, Buenos Aires, Argentina, C1408INH
- Local Institution
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Ciudad Auton., Buenos Aires, Argentina, C1505CWB
- Local Institution
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Mar Del Plata, Buenos Aires, Argentina, 7600
- Local Institution
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Zarate, Buenos Aires, Argentina, 2800
- Local Institution
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Cordoba
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Villa Carlos Paz, Cordoba, Argentina, 5152
- Local Institution
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Rio De Janeiro, Brasil, 20211
- Local Institution
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Ceara
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Fortaleza, Ceara, Brasil, 60021
- Local Institution
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Minas Gerais
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Itajuba, Minas Gerais, Brasil, 37502
- Local Institution
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Para
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Belem, Para, Brasil, 66073
- Local Institution
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Rio Grande Do Sul
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Caxias Do Sul, Rio Grande Do Sul, Brasil, 95070
- Local Institution
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Porto Alegre, Rio Grande Do Sul, Brasil, 90020090
- Local Institution
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Porto Alegre, Rio Grande Do Sul, Brasil, 90035
- Local Institution
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Sao Paulo
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Marilia, Sao Paulo, Brasil, 17519
- Local Institution
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Alberta
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Calgary, Alberta, Canada, T2R 0X7
- Local Institution
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 2H4
- Local Institution
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
- Local Institution
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New Brunswick
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Bathurst, New Brunswick, Canada, E2A 4X7
- Local Institution
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Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
- Local Institution
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St-John, Newfoundland and Labrador, Canada, A1E 2E2
- Local Institution
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Ontario
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Sarnia, Ontario, Canada, N7T 4X3
- Local Institution
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Thornhill, Ontario, Canada, L4J 8L7
- Local Institution
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Toronto, Ontario, Canada, M4R 2G4
- Local Institution
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Toronto, Ontario, Canada, M9W 4L6
- Local Institution
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 5Y9
- Local Institution
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Quebec
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Drummondville, Quebec, Canada, J2B 7T1
- Local Institution
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Granby, Quebec, Canada, J2G 8Z9
- Local Institution
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L'Ancienne Lorette, Quebec, Canada, G2E 2X1
- Local Institution
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Mirabel, Quebec, Canada, J7J 2K8
- Local Institution
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St-Leonard, Quebec, Canada, H1S 3A9
- Local Institution
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 3H3
- Local Institution
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Saskatoon, Saskatchewan, Canada, S7K 7H9
- Local Institution
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Arizona
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Tempe, Arizona, Forente stater, 85282
- Clinical Research Advantage / Desert Clinical Res, Llc
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California
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Encino, California, Forente stater, 91436
- Medical Group of Encino
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Fresno, California, Forente stater, 93720
- Valley Research
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Los Angeles, California, Forente stater, 90023
- Randall Shue, D.O.
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Northridge, California, Forente stater, 91325
- Diabetes Medical Center Of California
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San Diego, California, Forente stater, 92117
- Ritchken & First M.D.'S
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Spring Valley, California, Forente stater, 91978
- Encompass Clinical Research
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Torrance, California, Forente stater, 90505
- Raikhel, Marina
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Colorado
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Colorado Springs, Colorado, Forente stater, 80909
- Express Care Clinical Res
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Denver, Colorado, Forente stater, 80209
- Denver Internal Medicine
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Golden, Colorado, Forente stater, 80401
- New West Physicians
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Florida
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Altamonte Springs, Florida, Forente stater, 32701
- Central Florida Clinical Trials, Inc.
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Chipley, Florida, Forente stater, 32428
- Family Care Associates Of Nw Florida
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Minnesota
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Minneapolis, Minnesota, Forente stater, 56440
- Health Partners Research Foundation
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Missouri
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Chesterfield, Missouri, Forente stater, 63017
- Woodlake Research
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Nevada
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Las Vegas, Nevada, Forente stater, 89101
- Nevada Alliance Against Diabetes
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North Carolina
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Morehead City, North Carolina, Forente stater, 28557
- Diabetes & Endocrinology Consultants, PC
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Ohio
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Newark, Ohio, Forente stater, 43055
- Newark Physician Associates
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73159
- Integris Family Care S. Penn
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Pennsylvania
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Carlisle, Pennsylvania, Forente stater, 17013
- Cumberland Valley Endocrinology Center, Llc
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Pittsburgh, Pennsylvania, Forente stater, 15216
- Banksville Medical Pc
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South Carolina
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Summerville, South Carolina, Forente stater, 29485
- Palmetto Clinical Research
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Taylors, South Carolina, Forente stater, 29687
- Southeastern Research Assoc
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Texas
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Houston, Texas, Forente stater, 77081
- Texas Center For Drug Development, P.A.
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San Antonio, Texas, Forente stater, 78229
- Diabetes & Glandular Disease Research Associates, Inc.
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San Antonio, Texas, Forente stater, 78229
- S.A.M. Clinical Research Center
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Utah
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Salt Lake City, Utah, Forente stater, 84102
- Optimum Clinical Research
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Washington
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Spokane, Washington, Forente stater, 99216
- Office Of Dr. Gray
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Durango, Mexico, 64710
- Local Institution
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Distrito Federal
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Df, Distrito Federal, Mexico, 11800
- Local Institution
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Guadalajara, Distrito Federal, Mexico, 44670
- Local Institution
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Zapopan, Distrito Federal, Mexico, 45150
- Local Institution
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Jalisco
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Guadalajara, Jalisco, Mexico, 44650
- Local Institution
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Guadalajara, Jalisco, Mexico, 44670
- Local Institution
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, 64710
- Local Institution
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Monterrey, Nuevo Leon, Mexico, 64460
- Local Institution
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Monterrrey, Nuevo Leon, Mexico, 64700
- Local Institution
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Tamaulipas
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Tampico, Tamaulipas, Mexico, 89109
- Local Institution
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 77 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Key Inclusion Criteria
- Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
- Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
- C-peptide ≥1.0 ng/mL
- Body mass index ≤45.0 kg/m^2
- Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.
Key Exclusion Criteria
- Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
- Serum total bilirubin level >2 mg/dL
- Creatinine kinase level >3 times upper limit of normal
- Symptoms of severely uncontrolled diabetes
- Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
- Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
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Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
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Eksperimentell: Dapagliflozin, 2.5 mg + Metformin
Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
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Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andre navn:
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Eksperimentell: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
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Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andre navn:
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Eksperimentell: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
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Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Justert gjennomsnittlig endring fra baseline i hemoglobin A1C (HbA1c) ved uke 24 (siste observasjon videreført [LOCF])
Tidsramme: Fra baseline til uke 24
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HbA1c ble målt som prosent av hemoglobin av et sentrallaboratorium.
Data etter redningsmedisin ble ekskludert fra denne analysen.
Baseline ble definert som den siste vurderingen før startdatoen og klokkeslettet for den første dosen av den dobbeltblindede studiemedisinen.
I tilfeller der tidspunktet for den første dosen eller tidspunktet for vurderingen ikke var tilgjengelig, ble baseline definert som den siste vurderingen på eller før datoen for den første dosen av den dobbeltblindede studiemedisinen.
HbA1c-målinger ble oppnådd under kvalifiserings- og innkjøringsperioder og på dag 1 og uke 4, 8, 12, 16, 20 og 24 i den dobbeltblindede perioden.
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Fra baseline til uke 24
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 24
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Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
Data after rescue medication was excluded from this analysis.
Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
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From Baseline to Week 24
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Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 24
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Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.
Data after rescue medication was excluded from this analysis.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
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From Baseline to Week 24
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Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 24
|
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
Percent adjusted for baseline HbA1c.
Therapeutic glycemic response is defined as HbA1c <7.0%.
Data after rescue medication was excluded from this analysis.
HbA1c was measured as a percent of hemoglobin.
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From Baseline to Week 24
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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 24
|
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
HbA1c was measured as percent of hemoglobin by a central laboratory.
The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%.
Data after rescue medication were excluded from this analysis.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
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From Baseline to Week 24
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Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 24
|
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.)
Data after rescue medication was excluded from this analysis.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
|
From Baseline to Week 24
|
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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 24
|
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
Adjusted for baseline HbA1c.
HbA1c was measured as percent of hemoglobin by a central laboratory.
Data after rescue medication were excluded from this analysis.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
|
From Baseline to Week 24
|
|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 1
|
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
Data after rescue medication was excluded from this analysis.
Fasting plasma glucose was measured by a central laboratory.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
|
From Baseline to Week 1
|
|
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
Tidsramme: From Baseline to Week 24
|
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order.
Percent adjusted for baseline HbA1c.
Data after rescue medication was excluded from this analysis.
HbA1c was measured as a percent of hemoglobin.
|
From Baseline to Week 24
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
Tidsramme: From Baseline to end of Long-term Period (Week 102)
|
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Related=having certain, probable, possible, or missing relationship to study drug.
Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period.
Data after rescue included.
|
From Baseline to end of Long-term Period (Week 102)
|
|
Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
Tidsramme: Day 1 to Week 102
|
BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase.
Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL.
Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL.
Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66.
Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.
|
Day 1 to Week 102
|
|
Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
Tidsramme: Baseline to Week 102
|
12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine.
ECGs were assessed by the investigator.
Baseline was Day -7 for this parameter.
Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.
|
Baseline to Week 102
|
|
Mean Changes From Baseline in Seated Systolic Blood Pressure
Tidsramme: From Baseline to Week 102
|
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study.
Data after rescue were also included.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
|
From Baseline to Week 102
|
|
Mean Changes From Baseline in Seated Diastolic Blood Pressure
Tidsramme: From Baseline to Week 102
|
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study.
Data after rescue were also included.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
|
From Baseline to Week 102
|
|
Number of Participants With Orthostatic Hypotension
Tidsramme: From Baseline to Week 102
|
Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.
|
From Baseline to Week 102
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
- Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
- Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.
- Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
- Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43. Erratum In: BMC Med. 2013;11:193.
- Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2007
Primær fullføring (Faktiske)
1. november 2008
Studiet fullført (Faktiske)
1. mai 2010
Datoer for studieregistrering
Først innsendt
11. september 2007
Først innsendt som oppfylte QC-kriteriene
11. september 2007
Først lagt ut (Anslag)
12. september 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. oktober 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. september 2015
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MB102-014 LT
- MB102-014 (Annen identifikator: Other Study ID Numbers:)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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-
Jin-Hee AhnAsan Medical CenterUkjentHER-2 genamplifikasjon | HER-2 Protein Overekspresjon
-
The University of Tennessee, KnoxvilleFullførtMattelærere (2.–8. klasse) | Mattestudenter (2.–8. klasse)Forente stater
-
Instituto Nacional de Ciencias Medicas y Nutricion...Aktiv, ikke rekrutterende
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Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.UkjentSolid svulst | HER-2 genamplifikasjon | HER2 genmutasjon | HER-2 Protein OverekspresjonKina
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PowderMedFullført
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Kaiser PermanenteThe Permanente Medical GroupPåmelding etter invitasjonType 2 diabetes | Type 2 diabetes mellitus (T2DM) | Type 2-diabetes (T2D)Forente stater
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University of North Carolina, Chapel HillAmerican Heart AssociationRekrutteringType 2 diabetes | Ernæring | Diabetes type 2 | T2DM (type 2 diabetes mellitus) | Diabetes mellitt | T2DM | Diabetes utdanningForente stater
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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi... og andre samarbeidspartnereRekrutteringType 2 diabetes | Diabetes mellitus type 2Tyrkia (Türkiye)
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University of MiamiSexual Medicine Society of North America Inc.Har ikke rekruttert ennåType 2 diabetes | Type 2 diabetes (T2DM)Forente stater
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Embecta Corp.Jaeb Center for Health ResearchTilbaketrukketType 2 diabetes | Type 2 diabetes mellitus (T2DM) | T2DM (type 2 diabetes mellitus) | T2D | T2DM | Type 2 DM | T2DM med utilstrekkelig glykemisk kontrollForente stater
Kliniske studier på Placebo
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SamA Pharmaceutical Co., LtdUkjentAkutt bronkitt | Akutt øvre luftveisinfeksjonKorea, Republikken
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National Institute on Drug Abuse (NIDA)FullførtCannabisbrukForente stater
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AkesoHar ikke rekruttert ennåAtopisk dermatittKina
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyFullførtMannlige personer med type II diabetes (T2DM)Tyskland
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Heptares Therapeutics LimitedFullførtFarmakokinetikk | SikkerhetsproblemerStorbritannia
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CellmedisMedical Network Sp. z o.o.Har ikke rekruttert ennå
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Texas A&M UniversityNutraboltFullførtGlukose og insulinrespons
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Regado Biosciences, Inc.FullførtFrivillig friskForente stater
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LifeMine TherapeuticsRekruttering