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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01221545
First received: October 14, 2010
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: AZD1656
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state. [ Time Frame: From screening until Follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656 [ Time Frame: From pre-dose Day 1 to 48 hours after dose ] [ Designated as safety issue: No ]
  • Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656 [ Time Frame: Glucose levels from Day -1 to day 3 ] [ Designated as safety issue: No ]
  • Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656 [ Time Frame: Insuline secretion from Day -1 to 2. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A - AZD1656
AZD1656
 Drug: AZD1656
3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose.
Other Name: AZD1656
Placebo Comparator: B - Placebo
Placebo
 Drug: Placebo
Placebo
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221545

Locations
United States, California
Research Site
Chula Vista, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Linda Morrow, MD Profil Institute for Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Eva Johnsson MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01221545     History of Changes
Other Study ID Numbers: D1020C00044
Study First Received: October 14, 2010
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013