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

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ClinicalTrials.gov Identifier: NCT01221545
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: AZD1656 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : October 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Placebo Comparator: B - Placebo
Placebo
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Eva Johnsson MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01221545     History of Changes
Other Study ID Numbers: D1020C00044
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Diabetes Mellitus

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