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

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ClinicalTrials.gov Identifier: NCT01103609
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : November 8, 2010
Sponsor:
Information provided by:
AstraZeneca

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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 and Pharmacodynamics of Warfarin During Co-administration With AZD1656
Study Start Date : April 2010
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

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


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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:

  • 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

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): 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

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01103609     History of Changes
Other Study ID Numbers: D1020C00027
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: November 8, 2010
Last Verified: November 2010

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