To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: AZD1656; Drug: Placebo

• Registration Number: NCT00768105
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	AZD1656	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)	Blood samples taken repeatedly during 24 hours on study day sessions

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Chula Vista, California, United States