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A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes (MAD)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AZD1656

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 surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation >1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
HbA1c ≤10.5 % 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 ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)

Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetic variables

Pharmacodynamic variables

Full Information

NCT ID

NCT00747175

First Posted

September 3, 2008

Last Updated

December 2, 2010

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00747175

Brief Title

A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

Acronym

MAD

Official Title

A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (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 tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes

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

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)

Arm Title

Arm Type

Experimental

Arm Description

Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)

Intervention Type

Drug

Intervention Name(s)

AZD1656

Intervention Description

Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment

Intervention Type

Drug

Intervention Name(s)

AZD1656

Intervention Description

Dose titration of oral suspension to a tolerable dose, 1 month treatment

Primary Outcome Measure Information:

Title

Safety variables (AE, BP, pulse, plasma glucose, laboratory variables 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 surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation >1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment HbA1c ≤10.5 % 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 ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klas Malmberg, MD, Phd, Prof

Organizational Affiliation

AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Marcus Hompesch, MD

Organizational Affiliation

Profil Institute for Clinical Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Chula Vista

State/Province

California

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

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