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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01020123
Other study ID # D1020C00009
Secondary ID
Status Completed
Phase Phase 2
First received November 11, 2009
Last updated November 22, 2012
Start date October 2009
Est. completion date February 2011

Study information

Verified date November 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Chile: Instituto de Salud Pública de ChileGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthMexico: Federal Commission for Protection Against Health RisksPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients


Recruitment information / eligibility

Status Completed
Enrollment 530
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
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

Locations

Country Name City State
Chile Research Site Brentwood TN
Chile Research Site Santiago
Chile Research Site Temuco
Chile Research Site Temuco Novena Region
Germany Research Site Aschaffenburg
Germany Research Site Berlin
Germany Research Site Bochum
Germany Research Site Brentwood TN
Germany Research Site Dortmund
Germany Research Site Dresden SN
Germany Research Site Frankfurt
Germany Research Site Görlitz
Germany Research Site Hamburg
Germany Research Site Lubeck
Germany Research Site Magdeburg
Hungary Research Site Balatonfured
Hungary Research Site Bekescsaba
Hungary Research Site Dunaujvaros
Hungary Research Site Eger
Hungary Research Site Gyula
Hungary Research Site Kaposvar
Hungary Research Site Nyiregyhaza
Hungary Research Site St. Laurent QC
Hungary Research Site Szekszard
Hungary Research Site Szigetvar
Hungary Research Site Zalaegerszeg
Latvia Research Site Brentwood TN
Latvia Research Site Daugavpils
Latvia Research Site Jekabpils
Latvia Research Site Jelgava
Latvia Research Site Limbazi
Latvia Research Site Riga
Latvia Research Site Talsi
Latvia Research Site Valmiera
Lithuania Research Site Brentwood TN
Lithuania Research Site Kaunas
Mexico Research Site Aguascalientes
Mexico Research Site Brentwood TN
Mexico Research Site Chiuahua
Mexico Research Site Cuernavaca Morelos
Mexico Research Site Merida Yucatan
Mexico Research Site Meridas Yucatan
Mexico Research Site Monterrey
Mexico Research Site Monterrey Nuevo Leon
Mexico Research Site San Luis Potosi
Mexico Research Site Zapopan Jalisco
Peru Research Site Brentwood TN
Peru Research Site Callao
Peru Research Site Lambayeque
Peru Research Site Lima
Peru Research Site Piura
Peru Research Site Trujillo
Poland Research Site Brentwood TN
Poland Research Site Gdansk
Poland Research Site Krakow
Poland Research Site Kutno
Poland Research Site Wroclaw
Romania Research Site Alba Iulia Alba
Romania Research Site Brentwood TN
Romania Research Site Galati
Romania Research Site Ploiesti
Romania Research Site Sibiu
Romania Research Site Tg Mures Mures
Romania Research Site Timisoara
Sweden Research Site Brentwood TN
Sweden Research Site Huddinge
Sweden Research Site Lund
United Kingdom Research Site Cardiff
United Kingdom Research Site Chorley
United Kingdom Research Site Glasgow
United Kingdom Research Site Liverpool Merseyside
United Kingdom Research Site Paignton Devon
United Kingdom Research Site St. Laurent QC
United Kingdom Research Site Stevenage
United Kingdom Research Site West Bromwich
United Kingdom Research Site West Lothian

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Chile,  Germany,  Hungary,  Latvia,  Lithuania,  Mexico,  Peru,  Poland,  Romania,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c: Change From Baseline to 4 Month AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue Baseline to 4th Month No
Secondary FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue. AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue. baseline to 4 month No
Secondary SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue. AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue. baseline to 4 month No
Secondary OGTT/Plasma Glucose The relative change in AUC baseline to 4 month No
Secondary OGTT/Insulin The Relative Change in AUC FAS Prior to Rescue baseline to 4 month No
Secondary OGTT/C-peptide The relative change, FAS prior to rescue baseline to 4 month No
Secondary OGTT/Pro-insulin/Insulin The relative change, FAS prior to rescue baseline to 4 month No
Secondary HbA1c = 7 Number of responders = 7, FAS prior to rescue. baseline to 4 month No
Secondary HbA1c = 6.5 Number of Responders = 6.5, FAS Prior to Rescue baseline to 4 month No
Secondary LDL-C: Mean Ratio Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI. baseline to 4 month No
Secondary HDL-C: Change From Baseline Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI. baseline to 4 month No
Secondary Total Cholesterol: Change From Baseline Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI. baseline to 4 month No
Secondary Triglycerides: Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary C-reactive Protein: Change From Baseline Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI baseline to 4 month No
Secondary Systolic Blood Pressure, Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Diastolic Blood Pressure, Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Pulse, Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Weight, Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary QTcF; Electorcardiagram Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Haemoglobin; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Leukocytes; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Sodium; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Potassium; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Creatinine; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary ALT; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary AST; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Alkaline Phosphatase; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary Bilirubin; Change From Baseline Summary statistic of change from baseline baseline to 4 month No
Secondary CL/F to Characterise the PK Properties of AZD1656. The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given. at 4 month No
Secondary EC50 to Characterise the PD Properties of AZD1656. The value is model based. The value is independent treatment given. at 4 month No
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