Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes

Type II 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 During Four Weeks in T2DM Subjects Treated With Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856908
• Other study ID #: D1020C00020
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2009
• Last updated: November 27, 2012
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: November 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 Insulin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• type II diabetes patients, female with non child-bearing potential

• Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)

• HbA1c <11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard).

• FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)

Exclusion Criteria:

• History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease

• Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.

• Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Drug:
• AZD1656
Tolerable dose given twice daily
• Placebo
Tolerable dose given twice daily

Locations

Country	Name	City	State
United States	Research Site	Chula Vista	California

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 following the morning dose 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 evening 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 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.	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 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	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 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.	Baseline is the day before first dose, end of treatment is last day of treatment	No