- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020123
Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
November 22, 2012 updated by: AstraZeneca
A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group Study, With an Optional 2-month Extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients
The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
530
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santiago, Chile
- Research Site
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Temuco, Chile
- Research Site
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Novena Region
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Temuco, Novena Region, Chile
- Research Site
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TN
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Brentwood, TN, Chile
- Research Site
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Aschaffenburg, Germany
- Research Site
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Berlin, Germany
- Research Site
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Bochum, Germany
- Research Site
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Dortmund, Germany
- Research Site
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Frankfurt, Germany
- Research Site
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Görlitz, Germany
- Research Site
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Hamburg, Germany
- Research Site
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Lubeck, Germany
- Research Site
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Magdeburg, Germany
- Research Site
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SN
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Dresden, SN, Germany
- Research Site
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TN
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Brentwood, TN, Germany
- Research Site
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Balatonfured, Hungary
- Research Site
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Bekescsaba, Hungary
- Research Site
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Dunaujvaros, Hungary
- Research Site
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Eger, Hungary
- Research Site
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Gyula, Hungary
- Research Site
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Kaposvar, Hungary
- Research Site
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Nyiregyhaza, Hungary
- Research Site
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Szekszard, Hungary
- Research Site
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Szigetvar, Hungary
- Research Site
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Zalaegerszeg, Hungary
- Research Site
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QC
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St. Laurent, QC, Hungary
- Research Site
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Daugavpils, Latvia
- Research Site
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Jekabpils, Latvia
- Research Site
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Jelgava, Latvia
- Research Site
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Limbazi, Latvia
- Research Site
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Riga, Latvia
- Research Site
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Talsi, Latvia
- Research Site
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Valmiera, Latvia
- Research Site
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TN
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Brentwood, TN, Latvia
- Research Site
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Kaunas, Lithuania
- Research Site
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TN
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Brentwood, TN, Lithuania
- Research Site
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Aguascalientes, Mexico
- Research Site
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Chiuahua, Mexico
- Research Site
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Monterrey, Mexico
- Research Site
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San Luis Potosi, Mexico
- Research Site
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Jalisco
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Zapopan, Jalisco, Mexico
- Research Site
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Morelos
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Cuernavaca, Morelos, Mexico
- Research Site
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico
- Research Site
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TN
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Brentwood, TN, Mexico
- Research Site
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Yucatan
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Merida, Yucatan, Mexico
- Research Site
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Meridas, Yucatan, Mexico
- Research Site
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Callao, Peru
- Research Site
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Lambayeque, Peru
- Research Site
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Lima, Peru
- Research Site
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Piura, Peru
- Research Site
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Trujillo, Peru
- Research Site
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TN
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Brentwood, TN, Peru
- Research Site
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Gdansk, Poland
- Research Site
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Krakow, Poland
- Research Site
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Kutno, Poland
- Research Site
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Wroclaw, Poland
- Research Site
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TN
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Brentwood, TN, Poland
- Research Site
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Galati, Romania
- Research Site
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Ploiesti, Romania
- Research Site
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Sibiu, Romania
- Research Site
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Timisoara, Romania
- Research Site
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Alba
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Alba Iulia, Alba, Romania
- Research Site
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Mures
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Tg Mures, Mures, Romania
- Research Site
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TN
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Brentwood, TN, Romania
- Research Site
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Huddinge, Sweden
- Research Site
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Lund, Sweden
- Research Site
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TN
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Brentwood, TN, Sweden
- Research Site
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Cardiff, United Kingdom
- Research Site
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Chorley, United Kingdom
- Research Site
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Glasgow, United Kingdom
- Research Site
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Stevenage, United Kingdom
- Research Site
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West Bromwich, United Kingdom
- Research Site
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West Lothian, United Kingdom
- Research Site
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Devon
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Paignton, Devon, United Kingdom
- Research Site
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Merseyside
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Liverpool, Merseyside, United Kingdom
- Research Site
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QC
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St. Laurent, QC, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- female of non-childbearing potential
- 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:
- Significant cardiovascular event within the last 6 months prior to enrolment or heart failure New York Heart Association (NYHA) class III-IV.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 6
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AZD1656 placebo and glipizide placebo administered to 1 group of patients
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Experimental: 1
AZD1656
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Different doses of AZD1656 administered to 5 groups of patients
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Experimental: 2
AZD1656
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Different doses of AZD1656 administered to 5 groups of patients
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Experimental: 3
AZD1656
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Different doses of AZD1656 administered to 5 groups of patients
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Experimental: 4
AZD1656
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Different doses of AZD1656 administered to 5 groups of patients
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Experimental: 5
AZD1656
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Different doses of AZD1656 administered to 5 groups of patients
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Active Comparator: 7
Glipizide administered to 1 group of patients
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Glipizide administered to 1 group of patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c: Change From Baseline to 4 Month
Time Frame: Baseline to 4th Month
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AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue
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Baseline to 4th Month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
Time Frame: baseline to 4 month
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AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.
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baseline to 4 month
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SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
Time Frame: baseline to 4 month
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AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.
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baseline to 4 month
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OGTT/Plasma Glucose
Time Frame: baseline to 4 month
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The relative change in AUC
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baseline to 4 month
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OGTT/Insulin
Time Frame: baseline to 4 month
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The Relative Change in AUC FAS Prior to Rescue
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baseline to 4 month
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OGTT/C-peptide
Time Frame: baseline to 4 month
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The relative change, FAS prior to rescue
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baseline to 4 month
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OGTT/Pro-insulin/Insulin
Time Frame: baseline to 4 month
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The relative change, FAS prior to rescue
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baseline to 4 month
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HbA1c ≤ 7
Time Frame: baseline to 4 month
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Number of responders ≤ 7, FAS prior to rescue.
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baseline to 4 month
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HbA1c ≤ 6.5
Time Frame: baseline to 4 month
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Number of Responders ≤ 6.5, FAS Prior to Rescue
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baseline to 4 month
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LDL-C: Mean Ratio
Time Frame: baseline to 4 month
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Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
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baseline to 4 month
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HDL-C: Change From Baseline
Time Frame: baseline to 4 month
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Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
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baseline to 4 month
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Total Cholesterol: Change From Baseline
Time Frame: baseline to 4 month
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Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
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baseline to 4 month
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Triglycerides: Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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C-reactive Protein: Change From Baseline
Time Frame: baseline to 4 month
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Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI
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baseline to 4 month
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Systolic Blood Pressure, Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Diastolic Blood Pressure, Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Pulse, Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Weight, Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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QTcF; Electorcardiagram Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Haemoglobin; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Leukocytes; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Sodium; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Potassium; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Creatinine; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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ALT; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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AST; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Alkaline Phosphatase; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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Bilirubin; Change From Baseline
Time Frame: baseline to 4 month
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Summary statistic of change from baseline
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baseline to 4 month
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CL/F to Characterise the PK Properties of AZD1656.
Time Frame: at 4 month
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The value is calculated using an allometric model (of a patient weighting 75 kg).
The value is independent treatment given.
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at 4 month
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EC50 to Characterise the PD Properties of AZD1656.
Time Frame: at 4 month
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The value is model based.
The value is independent treatment given.
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at 4 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eva Johnsson, AstraZeneca R&D Mölndal
- Principal Investigator: John Wilding, DM FRCP, University Hospital Aintree
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
November 11, 2009
First Submitted That Met QC Criteria
November 24, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Estimate)
November 26, 2012
Last Update Submitted That Met QC Criteria
November 22, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1020C00009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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