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Completed

NCT Number: NCT00817778

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1656

Drug

Subjects will be treated with tolerable dose twice daily for another 24 days.

Placebo

Drug

Subjects will be treated with tolerable dose twice daily for another 24 days.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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