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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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