A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
31 marzo 2017 aggiornato da: AstraZeneca
A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin.
The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes.
The safety of this treatment will also be studied.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
163
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Quebec
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Gatineau, Quebec, Canada, J8V 2P5
- Local Institution
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Laval, Quebec, Canada, H7T 2P5
- Local Institution
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Longueuil, Quebec, Canada, J4N 1L6
- Local Institution
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Pointe-Claire, Quebec, Canada, H9R 4S3
- Local Institution
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Sherbrooke, Quebec, Canada, J1G 5K2
- Local Institution
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Arkansas
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Jonesboro, Arkansas, Stati Uniti, 72401
- NEA Clinic
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California
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Fresno, California, Stati Uniti, 93720
- Valley Research
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Greenbrae, California, Stati Uniti, 94904
- Bernstein, Richard
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Florida
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Jacksonville, Florida, Stati Uniti, 32205
- Jacksonville Center for Clinical Research
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Georgia
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Roswell, Georgia, Stati Uniti, 30076
- Endocrine Research Solutions, Inc.
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University
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Maryland
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Baltimore, Maryland, Stati Uniti, 21204
- Model Clinical Research LLC
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Missouri
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St. Louis, Missouri, Stati Uniti, 63128
- St. Louis Center for Clinical Research
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New York
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Medical University
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28801
- Mountain Diabetes and Endocrine Center
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Ohio
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Mentor, Ohio, Stati Uniti, 44060
- Your Diabetes Endocrine Nutrition Group
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Texas
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Dallas, Texas, Stati Uniti, 75231
- Research Institute of Dallas, P.A.
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San Antonio, Texas, Stati Uniti, 78229
- Diabetes And Glandular Disease Research Associates, P.A.
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Washington
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Renton, Washington, Stati Uniti, 98055
- Rainier Clinical Research Center
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53209
- Advanced Healthcare S.C.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
- Subjects receiving insulin and metformin and/or a thiazolidinedione
- Body Mass Index <=45.0 kg/m2
- Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
- No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)
Exclusion Criteria:
- History of type 1 diabetes
- AST and/or ALT >2.5 times the upper limit of normal
- Creatinine kinase ≥3 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- History of hypoglycemic unawareness
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Cohort 1
20 mg
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Tablets, Oral, once daily, up to 12 weeks
Altri nomi:
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Sperimentale: Cohort 2 - Arm 1
10 mg
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Tablets, Oral, once daily, up to 12 weeks
Altri nomi:
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Sperimentale: Cohort 2 - Arm 2
20 mg
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Tablets, Oral, once daily, up to 12 weeks
Altri nomi:
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Comparatore placebo: Cohort 2 - Arm 3
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Tablets, Oral, 0 mg, once daily, up to 12 weeks
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Lasso di tempo: From Baseline to Week 12
|
HbA1c was measured as percent of hemoglobin by a central laboratory.
Data after insulin uptitration 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.
HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.
|
From Baseline to Week 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Lasso di tempo: From Baseline to Week 12
|
Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory.
Data after insulin uptitration 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.
FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period.
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From Baseline to Week 12
|
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Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Lasso di tempo: From Baseline to Week 12
|
Therapeutic glycemic response is defined as HbA1c <7.0%.
Data after insulin uptitration was excluded from this analysis.
HbA1c was measured as a percent of hemoglobin.
|
From Baseline to Week 12
|
|
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Lasso di tempo: From Baseline to Week 12
|
Therapeutic glycemic response is defined as HbA1c <=6.5%.
Data after insulin uptitration was excluded from this analysis.
HbA1c was measured as a percent of hemoglobin.
|
From Baseline to Week 12
|
|
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Lasso di tempo: From Baseline to Week 12
|
Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis.
HbA1c was measured as a percent of hemoglobin.
|
From Baseline to Week 12
|
|
Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2
Lasso di tempo: From Baseline to Week 12
|
Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects.
TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period.
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From Baseline to Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- Wilding JP, Norwood P, T'joen C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. Diabetes Care. 2009 Sep;32(9):1656-62. doi: 10.2337/dc09-0517. Epub 2009 Jun 15.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2006
Completamento primario (Effettivo)
1 marzo 2008
Completamento dello studio (Effettivo)
1 marzo 2008
Date di iscrizione allo studio
Primo inviato
26 luglio 2006
Primo inviato che soddisfa i criteri di controllo qualità
26 luglio 2006
Primo Inserito (Stima)
27 luglio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 maggio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 marzo 2017
Ultimo verificato
1 marzo 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MB102-009
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .