Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

30-75 years

Phase:

PHASE1

Brief 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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2010

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT00774553

Start Date

October 1 2008

End Date

January 1 2010

Last Update

January 15 2010

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Research Site

San Antonio, Texas, United States

2

Research site

Ahmedabad, India