A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
31. marts 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
163
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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, Forenede Stater, 72401
- NEA Clinic
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California
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Fresno, California, Forenede Stater, 93720
- Valley Research
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Greenbrae, California, Forenede Stater, 94904
- Bernstein, Richard
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Florida
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Jacksonville, Florida, Forenede Stater, 32205
- Jacksonville Center for Clinical Research
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Georgia
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Roswell, Georgia, Forenede Stater, 30076
- Endocrine Research Solutions, Inc.
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University
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Maryland
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Baltimore, Maryland, Forenede Stater, 21204
- Model Clinical Research LLC
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Missouri
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St. Louis, Missouri, Forenede Stater, 63128
- St. Louis Center for Clinical Research
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New York
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mountain Diabetes and Endocrine Center
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Ohio
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Mentor, Ohio, Forenede Stater, 44060
- Your Diabetes Endocrine Nutrition Group
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Texas
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Dallas, Texas, Forenede Stater, 75231
- Research Institute of Dallas, P.A.
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San Antonio, Texas, Forenede Stater, 78229
- Diabetes And Glandular Disease Research Associates, P.A.
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Washington
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Renton, Washington, Forenede Stater, 98055
- Rainier Clinical Research Center
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53209
- Advanced Healthcare S.C.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Cohort 1
20 mg
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Tablets, Oral, once daily, up to 12 weeks
Andre navne:
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Eksperimentel: Cohort 2 - Arm 1
10 mg
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Tablets, Oral, once daily, up to 12 weeks
Andre navne:
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Eksperimentel: Cohort 2 - Arm 2
20 mg
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Tablets, Oral, once daily, up to 12 weeks
Andre navne:
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Placebo komparator: Cohort 2 - Arm 3
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Tablets, Oral, 0 mg, once daily, up to 12 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Tidsramme: 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.
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From Baseline to Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Tidsramme: 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
Tidsramme: From Baseline to Week 12
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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.
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From Baseline to Week 12
|
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Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Tidsramme: 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
|
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Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
Tidsramme: 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.
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From Baseline to Week 12
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Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2
Tidsramme: From Baseline to Week 12
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2006
Primær færdiggørelse (Faktiske)
1. marts 2008
Studieafslutning (Faktiske)
1. marts 2008
Datoer for studieregistrering
Først indsendt
26. juli 2006
Først indsendt, der opfyldte QC-kriterier
26. juli 2006
Først opslået (Skøn)
27. juli 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MB102-009
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .