Status:

COMPLETED

A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes

Lead Sponsor:

Abbott Products

Collaborating Sponsors:

Quintiles, Inc.

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes

Eligibility Criteria

Inclusion

  • Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c \>= 7%, but \< 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) \>40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT \> 1.5 times UNL, creatinine clearance \<60 mL/min

Exclusion

    Key Trial Info

    Start Date :

    December 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2010

    Estimated Enrollment :

    61 Patients enrolled

    Trial Details

    Trial ID

    NCT00924534

    Start Date

    December 1 2009

    End Date

    December 1 2010

    Last Update

    January 4 2012

    Active Locations (12)

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    Page 1 of 3 (12 locations)

    1

    Site Reference ID/Investigator# 54183

    Dimitrovgrad, Bulgaria, 6400

    2

    Site Reference ID/Investigator# 54182

    Pleven, Bulgaria, 5800

    3

    Site Reference ID/Investigator# 44722

    Plovdiv, Bulgaria, 4000

    4

    Site Reference ID/Investigator# 44723

    Sofia, Bulgaria, 1407