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Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01103609
First received: April 13, 2010
Last updated: November 5, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics and Pharmacodynamics of Warfarin in T2DM patients.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Warfarin
Drug: Placebo
Drug: AZD1656
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics 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 and Pharmacodynamics of Warfarin During Co-administration With AZD1656

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate the pharmacokinetics of warfarin after a single dose when administered alone and in combination with AZD1656 at steady state by assessment of AUC and Cmax of both enantiomers of warfarin (S- and R-warfarin). [ Time Frame: Serial PK blood samples will be taken on days 4-10 during the treatment periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the anticoagulant activity of warfarin upon co-administration with AZD1656 by assessment of prothrombin time (PT) and international normalised ratio (INR). [ Time Frame: Serial blood samples for warfarin PD measurements will be taken on days 4-10 during the treatment periods ] [ Designated as safety issue: No ]
  • To evaluate the safety of AZD1656 in combination with warfarin 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 ]
  • To describe the pharmacokinetics of AZD1656 and its metabolite during concomitant warfarin administration by assessment of AUC0-24, Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only). [ Time Frame: Serial PK blood samples will be taken on days 4-10 during the treatment periods ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: April 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
twice daily on Day 1 to Day 10, with Warfarin on Day 4
 Drug: Warfarin
Oral tablet od on Day 4
Drug: AZD1656
Oral tablet bd, stepwise increased
Placebo Comparator: 2
twice daily on Day 1 to Day 10, with Warfarin on Day 4
 Drug: Warfarin
Oral tablet od on Day 4
Drug: Placebo
Oral tablet bd, stepwise increased

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of T2DM treated with at least 1000 mg metformin as a single treatment or in combination with one other oral anti-diabetics for at least 2 months prior to screening. Doses of anti-diabetic treatment stable for at least 1 month
  • Fasting plasma glucose (FPG) at screening in the range of 6.0 to 15.0 mmol/L (108 to 270 mg/dL) and FPG in the range of 7.5 to 13.0 mmol/L (135 to 234 mg/dL) on Day 1
  • Haemoglobin (Hb) A1c >6.5% at screening

Exclusion Criteria:

  • Use of drugs with anticoagulant effects 3 weeks prior to first warfarin dosing
  • Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
  • Previous treatment with warfarin on clinical indication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103609

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Stanko Skrtic AstraZeneca
Principal Investigator: James Ritter, Prof Quintiles Drug Research Unit
Study Chair: Mirjana Kujacic AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01103609     History of Changes
Other Study ID Numbers: D1020C00027
Study First Received: April 13, 2010
Last Updated: November 5, 2010
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013