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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AZD1656

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Site
Research site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

AZD1656

Placebo

Outcomes

Primary Outcome Measures

Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)

Secondary Outcome Measures

Pharmacokinetic variables

Pharmacodynamic variables

Full Information

NCT ID

NCT00774553

First Posted

October 16, 2008

Last Updated

January 14, 2010

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00774553

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type 2 diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD1656

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

AZD1656

Intervention Description

Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

Primary Outcome Measure Information:

Title

Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)

Time Frame

Blood samples taken repeatedly during 24 hours on study day sessions

Secondary Outcome Measure Information:

Title

Pharmacokinetic variables

Time Frame

Blood samples taken repeatedly during 24 hours on study day sessions

Title

Pharmacodynamic variables

Time Frame

Blood samples taken repeatedly during 24 hours on study day sessions

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klas Malmberg, MD, PhD, Prof.,

Organizational Affiliation

AstraZeneca R&D Mölndal

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Dr Emanuel DeNoia, MD

Organizational Affiliation

Healthcare Discoveries LLC Icon Development Solutions

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sanjay Sharma, MD

Organizational Affiliation

Veeda Clinical Research Pvt. Ltd

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Research site

City

Ahmedabad

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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