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

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 Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774553
• Other study ID #: D1020C00015
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2008
• Last updated: January 14, 2010
• Start date: October 2008
• Est. completion date: January 2010

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female (with non child-bearing potential)

• Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t

• HbA1c <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: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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 given twice daily for 10 days.
• Placebo
Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

Locations

Country	Name	City	State
India	Research site	Ahmedabad
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight 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