Back to resultsA Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD1656
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A - AZD1656
B - Placebo
Arm Description
AZD1656
Placebo
Outcomes
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.
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01221545
Brief Title
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A - AZD1656
Arm Type
Experimental
Arm Description
AZD1656
Arm Title
B - Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD1656
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Morrow, MD
Organizational Affiliation
Profil Institute for Clinical Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
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