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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: AZD1656

• Registration Number: NCT00817778
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2012-07-24
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-16
• Last Update Submitted: 2012-10-16
• Results First Posted: 2012-11-16
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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
AZD1656	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

Primary Outcome Measures

Name	Time	Method
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
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
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
Weight, Change From Baseline to End of Treatment	Baseline is the day before first dose, end of treatment is last day of treatment
Clinically Relevant Change of Laboratory Variables	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

Name	Time	Method
Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656	Measured last day of treatment	Dose-adjusted to a total daily dose of 100 mg due to titrated doses
Maximum Plasma Concentration of AZD1656	Measured last day of treatment	Dose-adjusted to a morning dose of 50 mg due to titrated doses
Time to Reach Maximum Plasma Concentration of AZD1656	Measured last day of treatment
Terminal Elimination Half-life of AZD1656	Measured following the afternoon dose last day of treatment
Apparent Oral Clearance of AZD1656	Measured last day of treatment
P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment	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.
S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment	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.
S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States