Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00856908
First received: March 5, 2009
Last updated: November 27, 2012
Last verified: November 2012

March 5, 2009
November 27, 2012
February 2009
August 2009   (final data collection date for primary outcome measure)
  • Systolic Blood Pressure, Change From Baseline to End of Treatment [ Time Frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure, Change From Baseline to End of Treatment [ Time Frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period ] [ Designated as safety issue: No ]
  • Pulse, Change From Baseline to End of Treatment [ Time Frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period ] [ Designated as safety issue: No ]
  • Weight, Change From Baseline to End of Treatment [ Time Frame: Baseline is the day before first dose, end of treatment is last day of treatment ] [ Designated as safety issue: No ]
  • Clinically Relevant Change of Laboratory Variables [ Time Frame: Measured regularly from day before first dose to day after last dose ] [ Designated as safety issue: No ]
    Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG) [ Time Frame: Frequent measurements during the study period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00856908 on ClinicalTrials.gov Archive Site
  • Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656 [ Time Frame: Measured last day of treatment ] [ Designated as safety issue: No ]
    Dose-adjusted to a total daily dose of 100 mg due to titrated doses
  • Maximum Plasma Concentration of AZD1656 [ Time Frame: Measured following the morning dose last day of treatment ] [ Designated as safety issue: No ]
    Dose-adjusted to a morning dose of 50 mg due to titrated doses
  • Time to Reach Maximum Plasma Concentration of AZD1656 [ Time Frame: Measured last day of treatment ] [ Designated as safety issue: No ]
  • Terminal Elimination Half-life of AZD1656 [ Time Frame: Measured following the evening dose last day of treatment ] [ Designated as safety issue: No ]
  • Apparent Oral Clearance of AZD1656 [ Time Frame: Measured last day of treatment ] [ Designated as safety issue: No ]
  • P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment [ Time Frame: Baseline is the day before first dose, end of treatment is last day of treatment ] [ Designated as safety issue: No ]
    Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.
  • S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment [ Time Frame: Baseline is the day before first dose, end of treatment is last day of treatment ] [ Designated as safety issue: No ]
    Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100
  • S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment [ Time Frame: Baseline is the day before first dose, end of treatment is last day of treatment ] [ Designated as safety issue: No ]
    Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.
  • PK variables (Area under the plasma conc vs. time curve (AUC), max plasma conc (Cmax), Plasma conc immediately before the next dose (Ctrough), time to reach max plasma conc (tmax), terminal elimination half-life and apparent oral clearance (CL/F) [ Time Frame: One blood sample for analysis of plasma concentrations of AZD1656 taken on several days during the treatment period. A full PK profile for AZD1656 will also be taken on the last day of treatment ] [ Designated as safety issue: No ]
  • Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide) [ Time Frame: 24 hour monitoring during specific days during the study period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
A Randomised, Single-Blind, Placebo-Controlled, Phase IIa Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 During Four Weeks in T2DM Subjects Treated With Insulin

The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type II Diabetes
  • Drug: AZD1656
    Tolerable dose given twice daily
  • Drug: Placebo
    Tolerable dose given twice daily
  • Experimental: 1
    Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
    Intervention: Drug: AZD1656
  • Placebo Comparator: 2
    Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type II diabetes patients, female with non child-bearing potential
  • Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)
  • HbA1c <11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard).
  • FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)

Exclusion Criteria:

  • History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
  • Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.
  • Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00856908
D1020C00020
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Klas Malmberg, MD, PhD, Prof. AstraZeneca R&D Mölndal
Principal Investigator: Marcus Hompesch, MD Profil Institut for Clinical Research Inc.
AstraZeneca
November 2012

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