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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01095991
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
2
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomised, Open, Phase I Study in Patients With Type 2 Diabetes Mellitus Treated With Metformin to Evaluate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin and Vice Versa
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.

Drug: AZD1656
Oral tablet bd,

Drug: Sitagliptin
Oral tablet od
Other Names:
  • Januvia

    		•
    Experimental: 2

    Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.

    Drug: AZD1656
    Oral tablet bd,

    Drug: Sitagliptin
    Oral tablet od
    Other Names:
  • Januvia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of AUC0-24 and Cmax [Serial PK sampling will be done on Days 5, 10 and 15]

    Secondary Outcome Measures

    1. To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of tmax, t1/2 and CL/F [Serial PK sampling will be done on Days 5, 10 and 15]

    2. To evaluate the PK of the AZD1656 and its metabolite when AZD1656 is administered with and without sitagliptin by assessment of AUC0-24, Cmax, tmax and t1/2 [Serial PK sampling will be done on Days 5, 10 and 15]

    3. To evaluate the safety of AZD1656 with and without sitagliptin by assessment of adverse events (AEs), physical examination, electrocardiogram (ECG), pulse, blood pressure (BP), weight and FPG. [Paper ECG (days 1,2,3,6,7,8,11,16), BP/pulse preentry, every residential day. Weight, physical examination preentry and follow-up. FPG on preentry, day 1,6 and 11.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with confirmed type 2 diabetes mellitus for at least 2 months and treated with metformin.

    • Body mass index between ≥19 and ≤42 kg/m2.

    Exclusion Criteria:

    • Intake of another investigational drug within the last 30 days prior to enrolment.

    • Clinically significant illness or clinically relevant trauma.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Neuss Germany

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Stanko Skrtic, AstraZeneca Molndal Sweden
    • Principal Investigator: Christoph Kapitza, Profil Institut für Stoffwechselforschung GmbH
    • Study Director: Mirjana Kujacic, AstraZeneca Molndal Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01095991
    Other Study ID Numbers:
    • D1020C00032
    First Posted:
    Mar 30, 2010
    Last Update Posted:
    Jul 1, 2010
    Last Verified:
    Jun 1, 2010
    Keywords provided by , ,
    Type 2 Diabetes Mellitus, Sitagliptin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Jul 1, 2010