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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01103622
First received: April 13, 2010
Last updated: January 4, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: AZD1656
Drug: Digoxin
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by AstraZeneca:

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 [ Time Frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods ] [ Designated as safety issue: No ]

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. [ Time Frame: Safety assessments will be monitored throughout the study, from screening visit until follow up visit. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01103622     History of Changes
Other Study ID Numbers: D1020C00031
Study First Received: April 13, 2010
Last Updated: January 4, 2011
Health Authority: United States: Food and Drug Administration
Germany: The Bavarian State Ministry of the Environment and Public Health

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
Cardiotonic Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013