A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Insulin

AstraZeneca1 site in 1 country24 target enrollmentSeptember 2008

ConditionsType 2 Diabetes

InterventionsAZD1656 Placebo

DrugsAZD1656 Placebo

Overview

Phase: Phase 1
Intervention: AZD1656
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Enrollment: 24
Locations: 1
Primary Endpoint: Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

March 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Female with non child-bearing potential
•Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
•HbA1c below or equal to 11 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria

•Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
•History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
•Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Arms & Interventions

1

Intervention: AZD1656

2

Intervention: Placebo

Outcomes

Primary Outcomes

Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)

Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions

Secondary Outcomes

Pharmacokinetic variables(Blood samples taken repeatedly during 24 hours on study day sessions)
Pharmacodynamic variables(Blood samples taken repeatedly during 24 hours on study day sessions)