Back to resultsInvestigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD1656
Digoxin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Type 2, Digoxin, drug-drug interaction
Eligibility Criteria
Inclusion Criteria:
- Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
- Body mass index between ≥19 and ≤42 kg/m2.
- Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.
Exclusion Criteria:
- History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
- Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
- Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
twice daily Day 1 to Day 7; digoxin on day 4
twice daily Day 1 to Day 7; digoxin on day 4.
Outcomes
Primary Outcome Measures
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
Secondary Outcome Measures
evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.
describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).
describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01103622
Brief Title
Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
Official Title
An Open-label, Randomised, Placebo Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics of Digoxin During Co-administration With AZD1656
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, Type 2, Digoxin, drug-drug interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
twice daily Day 1 to Day 7; digoxin on day 4
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
twice daily Day 1 to Day 7; digoxin on day 4.
Intervention Type
Drug
Intervention Name(s)
AZD1656
Intervention Description
Oral tablet bd, step-wise increased dosage
Intervention Type
Drug
Intervention Name(s)
Digoxin
Other Intervention Name(s)
Digacin
Intervention Description
Oral tablet od on Day 4
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet bd, step-wise increased dosage
Primary Outcome Measure Information:
Title
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
Time Frame
Serial PK blood samples will be taken on days 4-8 during the treatment periods
Secondary Outcome Measure Information:
Title
evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.
Time Frame
Safety assessments will be monitored throughout the study, from screening visit until follow up visit.
Title
describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).
Time Frame
Serial PK blood samples will be taken on days 4-8 during the treatment periods
Title
describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.
Time Frame
Serial PK blood samples will be taken on days 4-8 during the treatment periods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
Body mass index between ≥19 and ≤42 kg/m2.
Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.
Exclusion Criteria:
History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanko Skrtic
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christoph Kapitza
Organizational Affiliation
Profil Institut für Stoffwechselforschung GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mirjana Kujacic
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
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