- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00528879
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
30. září 2015 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
915
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Buenos Aires, Argentina, 1431
- Local Institution
-
Cordoba, Argentina, 5000
- Local Institution
-
-
Buenos Aires
-
Capital Federal, Buenos Aires, Argentina, 1034
- Local Institution
-
Capital Federal, Buenos Aires, Argentina, 1429
- Local Institution
-
Capital Federal, Buenos Aires, Argentina, C1056ABJ
- Local Institution
-
Capital Federal, Buenos Aires, Argentina, C1425AGC
- Local Institution
-
Ciudad Auton, Buenos Aires, Argentina, C1408INH
- Local Institution
-
Ciudad Auton., Buenos Aires, Argentina, C1505CWB
- Local Institution
-
Mar Del Plata, Buenos Aires, Argentina, 7600
- Local Institution
-
Zarate, Buenos Aires, Argentina, 2800
- Local Institution
-
-
Cordoba
-
Villa Carlos Paz, Cordoba, Argentina, 5152
- Local Institution
-
-
-
-
-
Rio De Janeiro, Brazílie, 20211
- Local Institution
-
-
Ceara
-
Fortaleza, Ceara, Brazílie, 60021
- Local Institution
-
-
Minas Gerais
-
Itajuba, Minas Gerais, Brazílie, 37502
- Local Institution
-
-
Para
-
Belem, Para, Brazílie, 66073
- Local Institution
-
-
Rio Grande Do Sul
-
Caxias Do Sul, Rio Grande Do Sul, Brazílie, 95070
- Local Institution
-
Porto Alegre, Rio Grande Do Sul, Brazílie, 90020090
- Local Institution
-
Porto Alegre, Rio Grande Do Sul, Brazílie, 90035
- Local Institution
-
-
Sao Paulo
-
Marilia, Sao Paulo, Brazílie, 17519
- Local Institution
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2R 0X7
- Local Institution
-
-
British Columbia
-
Kelowna, British Columbia, Kanada, V1Y 2H4
- Local Institution
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3E 3P4
- Local Institution
-
-
New Brunswick
-
Bathurst, New Brunswick, Kanada, E2A 4X7
- Local Institution
-
-
Newfoundland and Labrador
-
Mount Pearl, Newfoundland and Labrador, Kanada, A1N 1W7
- Local Institution
-
St-John, Newfoundland and Labrador, Kanada, A1E 2E2
- Local Institution
-
-
Ontario
-
Sarnia, Ontario, Kanada, N7T 4X3
- Local Institution
-
Thornhill, Ontario, Kanada, L4J 8L7
- Local Institution
-
Toronto, Ontario, Kanada, M4R 2G4
- Local Institution
-
Toronto, Ontario, Kanada, M9W 4L6
- Local Institution
-
-
Prince Edward Island
-
Charlottetown, Prince Edward Island, Kanada, C1A 5Y9
- Local Institution
-
-
Quebec
-
Drummondville, Quebec, Kanada, J2B 7T1
- Local Institution
-
Granby, Quebec, Kanada, J2G 8Z9
- Local Institution
-
L'Ancienne Lorette, Quebec, Kanada, G2E 2X1
- Local Institution
-
Mirabel, Quebec, Kanada, J7J 2K8
- Local Institution
-
St-Leonard, Quebec, Kanada, H1S 3A9
- Local Institution
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Kanada, S7K 3H3
- Local Institution
-
Saskatoon, Saskatchewan, Kanada, S7K 7H9
- Local Institution
-
-
-
-
-
Durango, Mexiko, 64710
- Local Institution
-
-
Distrito Federal
-
Df, Distrito Federal, Mexiko, 11800
- Local Institution
-
Guadalajara, Distrito Federal, Mexiko, 44670
- Local Institution
-
Zapopan, Distrito Federal, Mexiko, 45150
- Local Institution
-
-
Jalisco
-
Guadalajara, Jalisco, Mexiko, 44650
- Local Institution
-
Guadalajara, Jalisco, Mexiko, 44670
- Local Institution
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexiko, 64710
- Local Institution
-
Monterrey, Nuevo Leon, Mexiko, 64460
- Local Institution
-
Monterrrey, Nuevo Leon, Mexiko, 64700
- Local Institution
-
-
Tamaulipas
-
Tampico, Tamaulipas, Mexiko, 89109
- Local Institution
-
-
-
-
Arizona
-
Tempe, Arizona, Spojené státy, 85282
- Clinical Research Advantage / Desert Clinical Res, Llc
-
-
California
-
Encino, California, Spojené státy, 91436
- Medical Group of Encino
-
Fresno, California, Spojené státy, 93720
- Valley Research
-
Los Angeles, California, Spojené státy, 90023
- Randall Shue, D.O.
-
Northridge, California, Spojené státy, 91325
- Diabetes Medical Center of California
-
San Diego, California, Spojené státy, 92117
- Ritchken & First M.D.'S
-
Spring Valley, California, Spojené státy, 91978
- Encompass Clinical Research
-
Torrance, California, Spojené státy, 90505
- Raikhel, Marina
-
-
Colorado
-
Colorado Springs, Colorado, Spojené státy, 80909
- Express Care Clinical Res
-
Denver, Colorado, Spojené státy, 80209
- Denver Internal Medicine
-
Golden, Colorado, Spojené státy, 80401
- New West Physicians
-
-
Florida
-
Altamonte Springs, Florida, Spojené státy, 32701
- Central Florida Clinical Trials, Inc.
-
Chipley, Florida, Spojené státy, 32428
- Family Care Associates Of Nw Florida
-
-
Minnesota
-
Minneapolis, Minnesota, Spojené státy, 56440
- Health Partners Research Foundation
-
-
Missouri
-
Chesterfield, Missouri, Spojené státy, 63017
- Woodlake Research
-
-
Nevada
-
Las Vegas, Nevada, Spojené státy, 89101
- Nevada Alliance Against Diabetes
-
-
North Carolina
-
Morehead City, North Carolina, Spojené státy, 28557
- Diabetes & Endocrinology Consultants, PC
-
-
Ohio
-
Newark, Ohio, Spojené státy, 43055
- Newark Physician Associates
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Spojené státy, 73159
- Integris Family Care S. Penn
-
-
Pennsylvania
-
Carlisle, Pennsylvania, Spojené státy, 17013
- Cumberland Valley Endocrinology Center, Llc
-
Pittsburgh, Pennsylvania, Spojené státy, 15216
- Banksville Medical Pc
-
-
South Carolina
-
Summerville, South Carolina, Spojené státy, 29485
- Palmetto Clinical Research
-
Taylors, South Carolina, Spojené státy, 29687
- Southeastern Research Assoc
-
-
Texas
-
Houston, Texas, Spojené státy, 77081
- Texas Center For Drug Development, P.A.
-
San Antonio, Texas, Spojené státy, 78229
- Diabetes & Glandular Disease Research Associates, Inc.
-
San Antonio, Texas, Spojené státy, 78229
- S.A.M. Clinical Research Center
-
-
Utah
-
Salt Lake City, Utah, Spojené státy, 84102
- Optimum Clinical Research
-
-
Washington
-
Spokane, Washington, Spojené státy, 99216
- Office Of Dr. Gray
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 77 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
|
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
|
Experimentální: 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
|
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
Ostatní jména:
|
Experimentální: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day 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
Ostatní jména:
|
Experimentální: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
|
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
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Upravená průměrná změna hemoglobinu A1C (HbA1c) od výchozí hodnoty ve 24. týdnu (poslední přenesené pozorování [LOCF])
Časové okno: Od základního stavu do týdne 24
|
HbA1c byl měřen jako procento hemoglobinu centrální laboratoří.
Údaje po záchranné medikaci byly z této analýzy vyloučeny.
Výchozí stav byl definován jako poslední hodnocení před datem a časem zahájení první dávky dvojitě zaslepené studijní medikace.
V případech, kdy čas první dávky nebo čas hodnocení nebyl k dispozici, byl výchozí stav definován jako poslední hodnocení v den nebo před datem první dávky dvojitě zaslepené studijní medikace.
Měření HbA1c byla získána během kvalifikačního a úvodního období a v den 1 a v týdnech 4, 8, 12, 16, 20 a 24 ve dvojitě zaslepeném období.
|
Od základního stavu do týdne 24
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Časové okno: From Baseline to Week 24
|
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.
|
From Baseline to Week 24
|
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
Časové okno: 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
|
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Časové okno: 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.
|
From Baseline to Week 24
|
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
Časové okno: 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.
|
From Baseline to Week 24
|
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])
Časové okno: 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
|
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])
Časové okno: 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])
Časové okno: 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])
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
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
Časové okno: 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
Časové okno: 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])
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2007
Primární dokončení (Aktuální)
1. listopadu 2008
Dokončení studie (Aktuální)
1. května 2010
Termíny zápisu do studia
První předloženo
11. září 2007
První předloženo, které splnilo kritéria kontroly kvality
11. září 2007
První zveřejněno (Odhad)
12. září 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
20. října 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. září 2015
Naposledy ověřeno
1. září 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MB102-014 LT
- MB102-014 (Jiný identifikátor: Other Study ID Numbers:)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Cukrovka typu 2
-
Hoffmann-La RocheDokončenoDiabetes 2. typu, Diabetes 1. typuRakousko, Spojené království
-
Services Hospital, LahoreDokončeno
-
Griffin HospitalCalifornia Walnut CommissionDokončenoDIABETES MELLITUS TYP 2Spojené státy
-
West China HospitalDokončeno
-
University of Roma La SapienzaNeznámýDiabetes Mellitus Typ 2 Reaktivita krevních destiček StatinItálie
-
Bristol-Myers SquibbDokončenoDiabetes, typ 2Spojené státy, Kanada, Mexiko, Portoriko, Austrálie, Polsko, Tchaj-wan
-
Universidade Federal de Ouro PretoDokončeno
-
Novo Nordisk A/SNáborDiabetes, typ 2Spojené státy, Indie, Španělsko, Polsko, Jižní Afrika, Bulharsko, Německo, Japonsko, Portoriko
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Churchill HospitalDokončenoDiabetes, typ 2Spojené království
-
Kyowa Kirin Co., Ltd.Dokončeno