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

  • Chile
      • Santiago, Chile
        • Research Site
      • Temuco, Chile
        • Research Site
    • Novena Region
      • Temuco, Novena Region, Chile
        • Research Site
    • TN
      • Brentwood, TN, Chile
        • Research Site
  • Germany
      • Aschaffenburg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Dortmund, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Görlitz, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
    • SN
      • Dresden, SN, Germany
        • Research Site
    • TN
      • Brentwood, TN, Germany
        • Research Site
  • Hungary
      • 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
      • Szekszard, Hungary
        • Research Site
      • Szigetvar, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
    • QC
      • St. Laurent, QC, Hungary
        • Research Site
  • Latvia
      • 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, Latvia
        • Research Site
    • TN
      • Brentwood, TN, Latvia
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
    • TN
      • Brentwood, TN, Lithuania
        • Research Site
  • Mexico
      • Aguascalientes, Mexico
        • Research Site
      • Chiuahua, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
    • Jalisco
      • Zapopan, Jalisco, Mexico
        • Research Site
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
    • TN
      • Brentwood, TN, Mexico
        • Research Site
    • Yucatan
      • Merida, Yucatan, Mexico
        • Research Site
      • Meridas, Yucatan, Mexico
        • Research Site
  • Peru
      • Callao, Peru
        • Research Site
      • Lambayeque, Peru
        • Research Site
      • Lima, Peru
        • Research Site
      • Piura, Peru
        • Research Site
      • Trujillo, Peru
        • Research Site
    • TN
      • Brentwood, TN, Peru
        • Research Site
  • Poland
      • Gdansk, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Kutno, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
    • TN
      • Brentwood, TN, Poland
        • Research Site
  • Romania
      • Galati, Romania
        • Research Site
      • Ploiesti, Romania
        • Research Site
      • Sibiu, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
    • Alba
      • Alba Iulia, Alba, Romania
        • Research Site
    • Mures
      • Tg Mures, Mures, Romania
        • Research Site
    • TN
      • Brentwood, TN, Romania
        • Research Site
  • Sweden
      • Huddinge, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
    • TN
      • Brentwood, TN, Sweden
        • Research Site
  • United Kingdom
      • Cardiff, United Kingdom
        • Research Site
      • 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
        • Research Site
    • Devon
      • Paignton, Devon, United Kingdom
        • Research Site
    • Merseyside
      • Liverpool, Merseyside, United Kingdom
        • Research Site
    • QC
      • St. Laurent, QC, United Kingdom
        • Research Site

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
Placebo Comparator: 6
Drug: Placebo
AZD1656 placebo and glipizide placebo administered to 1 group of patients
Experimental: 1
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients
Experimental: 2
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients
Experimental: 3
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients
Experimental: 4
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients
Experimental: 5
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients
Active Comparator: 7
Glipizide administered to 1 group of patients
Drug: Glipizide
Glipizide administered to 1 group of patients

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
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

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
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
SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
Time Frame: 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 4 month
OGTT/Plasma Glucose
Time Frame: baseline to 4 month
The relative change in AUC
baseline to 4 month
OGTT/Insulin
Time Frame: baseline to 4 month
The Relative Change in AUC FAS Prior to Rescue
baseline to 4 month
OGTT/C-peptide
Time Frame: baseline to 4 month
The relative change, FAS prior to rescue
baseline to 4 month
OGTT/Pro-insulin/Insulin
Time Frame: baseline to 4 month
The relative change, FAS prior to rescue
baseline to 4 month
HbA1c ≤ 7
Time Frame: baseline to 4 month
Number of responders ≤ 7, FAS prior to rescue.
baseline to 4 month
HbA1c ≤ 6.5
Time Frame: baseline to 4 month
Number of Responders ≤ 6.5, FAS Prior to Rescue
baseline to 4 month
LDL-C: Mean Ratio
Time Frame: baseline to 4 month
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
baseline to 4 month
HDL-C: Change From Baseline
Time Frame: baseline to 4 month
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
baseline to 4 month
Total Cholesterol: Change From Baseline
Time Frame: baseline to 4 month
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
baseline to 4 month
Triglycerides: Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
C-reactive Protein: Change From Baseline
Time Frame: baseline to 4 month
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI
baseline to 4 month
Systolic Blood Pressure, Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Diastolic Blood Pressure, Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Pulse, Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Weight, Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
QTcF; Electorcardiagram Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Haemoglobin; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Leukocytes; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Sodium; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Potassium; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Creatinine; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
ALT; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
AST; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Alkaline Phosphatase; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
Bilirubin; Change From Baseline
Time Frame: baseline to 4 month
Summary statistic of change from baseline
baseline to 4 month
CL/F to Characterise the PK Properties of AZD1656.
Time Frame: at 4 month
The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.
at 4 month
EC50 to Characterise the PD Properties of AZD1656.
Time Frame: at 4 month
The value is model based. The value is independent treatment given.
at 4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

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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