To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069926
First received: February 16, 2010
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.


Condition Intervention Phase
Glucose Lowering
Drug: AZD1656
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase I, Multi-center, Open-label, Single Dose Study, to Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients With or Without Renal Impairment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline [ Time Frame: The baseline values will be as follows: ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety of AZD1656 in T2DM patients with various degrees of renal impairment. To describe the pharmacodynamics of AZD1656 in T2DM patients with various degrees of renal impairment by assessment of 24-hours glucose profile [ Time Frame: blood samples will be collected for up to 48 hours postdose and urine samples for up to 12 hours postdose for measurement of plasma and urine concentrations of AZD1656 and its metabolite ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD1656
    Single dose oral tablet
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any OAD or insulin
  • Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal

Exclusion Criteria:

  • Clinically significant progression of current disease or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
  • Clinically significant neuropathy according to the Investigator. However subjects with diabetic neuropathy which is not clinically significant according to the Investigator may be included.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069926

Locations
United States, Florida
Research Site
Orlando, Florida, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, Tennessee
Research Site
Knoxville, Tennessee, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: William Smith, MD University of Tennessee Medical Center
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01069926     History of Changes
Other Study ID Numbers: D1020C00007
Study First Received: February 16, 2010
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014