To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

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Detailed Description

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This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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6 - 8 cohorts

6 patients in each cohort will receive AZD5658

Group Type EXPERIMENTAL

No interventions assigned to this group

6 - 8 cohorts

2 patients in each cohort will receive placebo

Group Type PLACEBO_COMPARATOR

AZD5658

Intervention Type DRUG

oral suspension, escalating single doses

Placebo

Intervention Type DRUG

oral suspension,single doses

Interventions

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AZD5658

oral suspension, escalating single doses

Intervention Type DRUG

Placebo

oral suspension,single doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must be of non-childbearing potential.
* Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
* Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin

Exclusion Criteria

* Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
* Participation in another clinical study during the last 30 days prior to enrollment
* Significant cardiovascular event within the last 6 months prior to enrollment

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No