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

December 30, 2011 updated by: Abbott Products

A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dimitrovgrad, Bulgaria, 6400
        • Site Reference ID/Investigator# 54183
      • Pleven, Bulgaria, 5800
        • Site Reference ID/Investigator# 54182
      • Plovdiv, Bulgaria, 4000
        • Site Reference ID/Investigator# 44722
      • Sofia, Bulgaria, 1407
        • Site Reference ID/Investigator# 44723
  • Poland
      • Lubin, Poland, 59-301
        • Site Reference ID/Investigator# 44725
      • Pulawy, Poland, 24-100
        • Site Reference ID/Investigator# 44724
      • Radzymin, Poland, 05-250
        • Site Reference ID/Investigator# 54185
      • Ruda Slaska, Poland
        • Site Reference ID/Investigator# 44727
      • Wroclaw, Poland, 50-349
        • Site Reference ID/Investigator# 54184
  • South Africa
      • Cape Town, South Africa, 7130
        • Site Reference ID/Investigator# 44728
      • Cape Town, South Africa, 7937
        • Site Reference ID/Investigator# 44730
      • Johannesburg, South Africa, 2198
        • Site Reference ID/Investigator# 44729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: SLV337
SLV337 400 mg/day
Drug: SLV337
SLV337 800 mg/day
Drug: SLV337
SLV337 1400 mg/day
Placebo Comparator: 1
Drug: Placebo
Placebo
Experimental: 3
Drug: SLV337
SLV337 400 mg/day
Drug: SLV337
SLV337 800 mg/day
Drug: SLV337
SLV337 1400 mg/day
Experimental: 4
Drug: SLV337
SLV337 400 mg/day
Drug: SLV337
SLV337 800 mg/day
Drug: SLV337
SLV337 1400 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in alanine amino transferase level to Day 35
Time Frame: 35 days
35 days
Change from baseline in Creatinine level to Day 35
Time Frame: 35 days
35 days
Change from baseline in the count of Red blood cells to Day 35
Time Frame: 35 days
35 days
Change from baseline in White blood cells count to Day 35
Time Frame: 35 days
35 days
Change from baseline in Creatinine kinase level to Day 35
Time Frame: 35 days
35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Fasting plasma glucose level to Day 28
Time Frame: 28 days
28 days
Change from baseline in Adiponectin level to Day 28
Time Frame: 28 days
28 days
Change from baseline in Triglycerides level to Day 28
Time Frame: 28 days
28 days
Change from baseline in High density lipoprotein cholesterol level to Day 28
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Products

Collaborators

Quintiles, Inc.

Investigators

  • Study Director: Francis Roy, MS, Abbott Products

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (Estimate)

June 19, 2009

Study Record Updates

Last Update Posted (Estimate)

January 4, 2012

Last Update Submitted That Met QC Criteria

December 30, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S337.2.001
  • 2009-011589-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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