Clinical trial NCT00817778: Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Type II Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 27
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 Metformin


Eligibility criteria: 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

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 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 afternoon 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: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD, Prof
role: STUDY_DIRECTOR
affiliation: Healthcare Discoveries LLC Icon Development Solutions
name: Emanuel P DeNoia, M.D
role: PRINCIPAL_INVESTIGATOR
References: