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

December 2, 2010 updated by: AstraZeneca

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

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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)
Drug: AZD1656
Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment
Drug: AZD1656
Dose titration of oral suspension to a tolerable dose, 1 month treatment
Experimental: 2
Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)
Drug: AZD1656
Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment
Drug: AZD1656
Dose titration of oral suspension to a tolerable dose, 1 month treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Klas Malmberg, MD, Phd, Prof, AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1020C00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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