Assessment of the safety, tolerability and pharmacodynamics after administration of one dose of AZD8601 to male patients with type II diabetes mellitus (T2DM)

Study identifier:D9150C00001

ClinicalTrials.gov identifier:NCT02935712

EudraCT identifier:2016-002316-40

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomized, Single-Blind, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacodynamics Of AZD8601 After Single Dose Administration to Male Patients With Type II Diabetes Mellitus (T2DM)

Medical condition

Male subjects with type II diabetes (T2DM)

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD8601+Placebo (SAD), AZD8601+Placebo, Placebo+Placebo

Sex

Male

Actual Enrollment

44

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 16 Dec 2016
Primary Completion Date: 04 Aug 2017
Study Completion Date: 08 Jan 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL International GmbH, Spandauer Damm 130, 14050, Berlin, Germany

Inclusion and exclusion criteria