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Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT01103622
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : January 5, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: AZD1656 Drug: Digoxin Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
twice daily Day 1 to Day 7; digoxin on day 4
Drug: AZD1656
Oral tablet bd, step-wise increased dosage
Drug: Digoxin
Oral tablet od on Day 4
Other Name: Digacin
Placebo Comparator: 2
twice daily Day 1 to Day 7; digoxin on day 4.
Drug: Digoxin
Oral tablet od on Day 4
Other Name: Digacin
Drug: Placebo
Oral tablet bd, step-wise increased dosage


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103622


Locations
United States, California
Research Site
Chula Vista, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Stanko Skrtic AstraZeneca
Principal Investigator: Christoph Kapitza Profil Institut für Stoffwechselforschung GmbH
Study Chair: Mirjana Kujacic AstraZeneca
More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01103622     History of Changes
Other Study ID Numbers: D1020C00031
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Diabetes
Type 2
Digoxin
drug-drug interaction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs