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

NCT ID: NCT00924534

Last Updated: 2012-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

2

Group Type EXPERIMENTAL

SLV337

Intervention Type DRUG

SLV337 400 mg/day

3

Group Type EXPERIMENTAL

SLV337

Intervention Type DRUG

SLV337 800 mg/day

4

Group Type EXPERIMENTAL

SLV337

Intervention Type DRUG

SLV337 1400 mg/day

Interventions

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Placebo

Placebo

Intervention Type DRUG

SLV337

SLV337 400 mg/day

Intervention Type DRUG

SLV337

SLV337 800 mg/day

Intervention Type DRUG

SLV337

SLV337 1400 mg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

Abbott Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis Roy, MS

Role: STUDY_DIRECTOR

Abbott Products

Locations

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Site Reference ID/Investigator# 54183

Dimitrovgrad, , Bulgaria

Site Status

Site Reference ID/Investigator# 54182

Pleven, , Bulgaria

Site Status

Site Reference ID/Investigator# 44722

Plovdiv, , Bulgaria

Site Status

Site Reference ID/Investigator# 44723

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 44725

Lubin, , Poland

Site Status

Site Reference ID/Investigator# 44724

Puławy, , Poland

Site Status

Site Reference ID/Investigator# 54185

Radzymin, , Poland

Site Status

Site Reference ID/Investigator# 44727

Ruda Śląska, , Poland

Site Status

Site Reference ID/Investigator# 54184

Wroclaw, , Poland

Site Status

Site Reference ID/Investigator# 44728

Cape Town, , South Africa

Site Status

Site Reference ID/Investigator# 44730

Cape Town, , South Africa

Site Status

Site Reference ID/Investigator# 44729

Johannesburg, , South Africa

Site Status

Countries

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Bulgaria Poland South Africa

Other Identifiers

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2009-011589-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S337.2.001

Identifier Type: -

Identifier Source: org_study_id

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