NCT01221545

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

October 14, 2010

Last Update Submit

February 16, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (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.

    From screening until Follow up

Secondary Outcomes (3)

  • 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

    From pre-dose Day 1 to 48 hours after dose

  • 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

    Glucose levels from Day -1 to day 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

    Insuline secretion from Day -1 to 2.

Study Arms (2)

A - AZD1656

EXPERIMENTAL

AZD1656

Drug: AZD1656

B - Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD1656DRUG

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.

A - AZD1656
PlaceboDRUG

Placebo

B - Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Chula Vista, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Linda Morrow, MD

    Profil Institute for Clinical Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 15, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

US(1)