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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

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

Safety and tolerability after four weeks of treatment with AZD1656 in patients with type 2 diabetes

Research Site

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

Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters

Age Continuous

Gender, Male/Female

The primary objective of the study was to assess safety and tolerability and hence the study was not sized based on statistical considerations. The most import outcome, "no safety or tolerability concerns were identified", is not a numerical variable

Systolic Blood Pressure, change from baseline to end of treatment

Diastolic Blood Pressure, change from baseline to end of treatment

Pulse, change from baseline to end of treatment

Weight, change from baseline to end of treatment

Clinically Relevant Change of Laboratory Variables

Dose-adjusted to a total daily dose of 100 mg due to titrated doses

Area under the plasma concentration vs time curve (AUC0-24) of AZD1656

Dose-adjusted to a morning dose of 50 mg due to titrated doses

Maximum plasma concentration of AZD1656

Time to reach maximum plasma concentration of AZD1656

Terminal elimination half-life of AZD1656

Apparent oral clearance of AZD1656

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.

P-Glucose (AUC0-24)/24, change from baseline to end of treatment

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

Arms	Assigned Interventions
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	Drug: AZD1656 Tolerable dose given twice daily
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	Drug: Placebo Tolerable dose given twice daily

Safety and tolerability after four weeks of treatment with AZD1656 in patients with type 2 diabetes

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=249&filename=CSR-D1020C00020.pdf

CSR-D1020C00020.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator