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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: AZD1656; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India
    • Research Site
• United States
  • Texas
    • San Antonio, Texas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.
Experimental: 1; AZD1656	Drug: AZD1656; Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamic variables	Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacokinetic variables	Blood samples taken repeatedly during 24 hours on study day sessions

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Klas Malmberg, MD, PhD, Prof.,, AstraZeneca R&D Mölndal; Principal Investigator: Dr Emanuel DeNoia, MD, Healthcare Discoveries LLC Icon Development Solutions; Principal Investigator: Sanjay Sharma, MD, Veeda Clinical Research Pvt. Ltd

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 17, 2008

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Type 2 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1020C00015