Clinical trial NCT00856908: Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Diabetes
Keywords: Type II Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Insulin


Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure, Change From Baseline to End of Treatment
timeFrame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
measure: Diastolic Blood Pressure, Change From Baseline to End of Treatment
timeFrame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
measure: Pulse, Change From Baseline to End of Treatment
timeFrame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
measure: Weight, Change From Baseline to End of Treatment
timeFrame: Baseline is the day before first dose, end of treatment is last day of treatment
measure: Clinically Relevant Change of Laboratory Variables
timeFrame: Measured regularly from day before first dose to day after last dose
Secondary outcomes:
measure: Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656
timeFrame: Measured last day of treatment
measure: Maximum Plasma Concentration of AZD1656
timeFrame: Measured following the morning dose last day of treatment
measure: Time to Reach Maximum Plasma Concentration of AZD1656
timeFrame: Measured last day of treatment
measure: Terminal Elimination Half-life of AZD1656
timeFrame: Measured following the evening dose last day of treatment
measure: Apparent Oral Clearance of AZD1656
timeFrame: Measured last day of treatment
measure: P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment
timeFrame: Baseline is the day before first dose, end of treatment is last day of treatment
measure: S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment
timeFrame: Baseline is the day before first dose, end of treatment is last day of treatment
measure: S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment
timeFrame: Baseline is the day before first dose, end of treatment is last day of treatment
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD, Prof.
role: STUDY_DIRECTOR
affiliation: Profil Institut for Clinical Research Inc.
name: Marcus Hompesch, MD
role: PRINCIPAL_INVESTIGATOR
References: