Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
NCT ID: NCT01020123
Last Updated: 2012-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
530 participants
INTERVENTIONAL
2009-10-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
AZD1656
AZD1656
Different doses of AZD1656 administered to 5 groups of patients
2
AZD1656
AZD1656
Different doses of AZD1656 administered to 5 groups of patients
3
AZD1656
AZD1656
Different doses of AZD1656 administered to 5 groups of patients
4
AZD1656
AZD1656
Different doses of AZD1656 administered to 5 groups of patients
5
AZD1656
AZD1656
Different doses of AZD1656 administered to 5 groups of patients
6
Placebo
AZD1656 placebo and glipizide placebo administered to 1 group of patients
7
Glipizide administered to 1 group of patients
Glipizide
Glipizide administered to 1 group of patients
Interventions
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AZD1656
Different doses of AZD1656 administered to 5 groups of patients
Placebo
AZD1656 placebo and glipizide placebo administered to 1 group of patients
Glipizide
Glipizide administered to 1 group of patients
Eligibility Criteria
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Inclusion Criteria
* Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment.
* Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort 1.Patients with HbA1c between \>10 % and \<12 % can enter the open-label arm with AZD1656 (cohort 2)
Exclusion Criteria
* Impaired renal function in terms of GFR\<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculation.
* Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Eva Johnsson
Role: STUDY_DIRECTOR
AstraZeneca R&D Mölndal
John Wilding, DM FRCP
Role: PRINCIPAL_INVESTIGATOR
University Hospital Aintree
Locations
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Research Site
Temuco, Región de la Araucanía, Chile
Research Site
Brentwood, TN, Chile
Research Site
Santiago, , Chile
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Temuco, , Chile
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Dresden, Saxony, Germany
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Brentwood, TN, Germany
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Aschaffenburg, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Dortmund, , Germany
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Frankfurt, , Germany
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Görlitz, , Germany
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Hamburg, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Saint Laurent, QC, Hungary
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Balatonfüred, , Hungary
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Békéscsaba, , Hungary
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Dunaújváros, , Hungary
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Eger, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Nyíregyháza, , Hungary
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Szekszárd, , Hungary
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Szigetvár, , Hungary
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Zalaegerszeg, , Hungary
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Brentwood, TN, Latvia
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Daugavpils, , Latvia
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Jelgava, , Latvia
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Jēkabpils, , Latvia
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Limbaži, , Latvia
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Riga, , Latvia
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Talsi, , Latvia
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Valmiera, , Latvia
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Brentwood, TN, Lithuania
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Kaunas, , Lithuania
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Aguascalientes, Aguascalientes, Mexico
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Zapopan, Jalisco, Mexico
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Monterrey, Mexico, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Brentwood, TN, Mexico
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Meridas, Yucatán, Mexico
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Mérida, Yucatán, Mexico
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Chiuahua, , Mexico
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San Luis Potosí City, , Mexico
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Lima, Lima Province, Peru
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Brentwood, TN, Peru
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Callao, , Peru
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Lambayeque, , Peru
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Lima, , Peru
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Piura, , Peru
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Trujillo, , Peru
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Brentwood, TN, Poland
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Gdansk, , Poland
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Krakow, , Poland
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Kutno, , Poland
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Wroclaw, , Poland
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Alba Iulia, Alba, Romania
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Tg Mures, Mureș County, Romania
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Brentwood, TN, Romania
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Galati, , Romania
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Ploieşti, , Romania
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Sibiu, , Romania
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Timișoara, , Romania
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Brentwood, TN, Sweden
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Huddinge, , Sweden
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Lund, , Sweden
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Paignton, Devon, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Saint Laurent, QC, United Kingdom
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Cardiff, , United Kingdom
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Chorley, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Stevenage, , United Kingdom
Research Site
West Bromwich, , United Kingdom
Research Site
West Lothian, , United Kingdom
Countries
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Other Identifiers
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D1020C00009
Identifier Type: -
Identifier Source: org_study_id