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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

February 16, 2010
December 8, 2010
March 2010
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01069926 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Glucose Lowering
Drug: AZD1656
Single dose oral tablet
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01069926
D1020C00007
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: William Smith, MD University of Tennessee Medical Center
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP