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Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

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ClinicalTrials.gov Identifier: NCT00817778
Recruitment Status : Completed
First Posted : January 6, 2009
Results First Posted : November 16, 2012
Last Update Posted : November 16, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 Metformin

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: AZD1656 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised, Single-Blind, Placebo-Controlled, Phase IIA Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD1656
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
 Drug: AZD1656
Subjects will be treated with tolerable dose twice daily for another 24 days.
Placebo Comparator: Placebo
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
 Drug: Placebo
Subjects will be treated with tolerable dose twice daily for another 24 days.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Clinically Relevant Change of Laboratory Variables [ Time Frame: Measured regularly from day before first dose to day after last dose ]
    Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656 [ Time Frame: Measured last day of treatment ]
    Dose-adjusted to a total daily dose of 100 mg due to titrated doses

  2. Maximum Plasma Concentration of AZD1656 [ Time Frame: Measured last day of treatment ]
    Dose-adjusted to a morning dose of 50 mg due to titrated doses

  3. Time to Reach Maximum Plasma Concentration of AZD1656 [ Time Frame: Measured last day of treatment ]
  4. Terminal Elimination Half-life of AZD1656 [ Time Frame: Measured following the afternoon dose last day of treatment ]
  5. Apparent Oral Clearance of AZD1656 [ Time Frame: Measured last day of treatment ]
  6. 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 ]
    Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect 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.

  7. 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 ]
    Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect 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.

  8. 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 ]
    Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
  • Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
  • HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard)

Exclusion Criteria:

  • History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
  • Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817778


Locations
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United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Klas Malmberg, MD, PhD, Prof AstraZeneca R&D Mölndal
Principal Investigator: Emanuel P DeNoia, M.D Healthcare Discoveries LLC Icon Development Solutions
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00817778    
Other Study ID Numbers: D1020C00019
First Posted: January 6, 2009    Key Record Dates
Results First Posted: November 16, 2012
Last Update Posted: November 16, 2012
Last Verified: October 2012
Keywords provided by AstraZeneca:
Type II Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases