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A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients

A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After High Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (T2DM) Patients

NCT01221545•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.

Eligibility

Age

20 - 60 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated, written informed consent prior to any study specific procedures.
•Male, T2DM patients aged 20-60 years
•Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
•Patients should not have been treated with glitazones within 6 months prior to enrollment
•Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).

Exclusion Criteria

•History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
•Prolonged QTcF\>450 msec or shortened QTcF\<350 msec or family history of long QT syndrome.
•Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
•Systolic BP\>159 mmHg or diastolic BP\>99 mmHg at screening and on Day-1

Locations (1)

Research Site

Chula Vista, California, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

January 1, 2011

Completion Date

January 1, 2011

Last Updated

February 17, 2011

Enrollment

ESTIMATED participants

Conditions

Type 2 Diabetes Mellitus

Interventions

AZD1656

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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