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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014