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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817778
• Other study ID #: D1020C00019
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2009
• Last updated: October 16, 2012
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• AZD1656
Subjects will be treated with tolerable dose twice daily for another 24 days.
• Placebo
Subjects will be treated with tolerable dose twice daily for another 24 days.

Locations

Country	Name	City	State
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure, Change From Baseline to End of Treatment		Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period	No
Primary	Diastolic Blood Pressure, Change From Baseline to End of Treatment		Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period	No
Primary	Pulse, Change From Baseline to End of Treatment		Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period	No
Primary	Weight, Change From Baseline to End of Treatment		Baseline is the day before first dose, end of treatment is last day of treatment	No
Primary	Clinically Relevant Change of Laboratory Variables	Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters	Measured regularly from day before first dose to day after last dose	No
Secondary	Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656	Dose-adjusted to a total daily dose of 100 mg due to titrated doses	Measured last day of treatment	No
Secondary	Maximum Plasma Concentration of AZD1656	Dose-adjusted to a morning dose of 50 mg due to titrated doses	Measured last day of treatment	No
Secondary	Time to Reach Maximum Plasma Concentration of AZD1656		Measured last day of treatment	No
Secondary	Terminal Elimination Half-life of AZD1656		Measured following the afternoon dose last day of treatment	No
Secondary	Apparent Oral Clearance of AZD1656		Measured last day of treatment	No
Secondary	P-Glucose (AUC0-24)/24, Change From Baseline to End 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.	Baseline is the day before first dose, end of treatment is last day of treatment	No
Secondary	S-Insulin (AUC0-24)/24, Change From Baseline to End 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.	Baseline is the day before first dose, end of treatment is last day of treatment	No
Secondary	S-C-Peptide (AUC0-24)/24, Change From Baseline to End 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.	Baseline is the day before first dose, end of treatment is last day of treatment	No