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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768105
• Other study ID #: D1020C00014
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2008
• Last updated: December 2, 2010
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• AZD1656
Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.
• Placebo
Dosing to match AZD1656

Locations

Country	Name	City	State
United States	Research Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)		Blood samples taken repeatedly during 24 hours on study day sessions	Yes
Secondary	Pharmacokinetic variables		Blood samples taken repeatedly during 24 hours on study day sessions	No
Secondary	Pharmacodynamic variables		Blood samples taken repeatedly during 24 hours on study day sessions	No