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Completed

NCT Number: NCT00924534

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 54183, Dimitrovgrad, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo

SLV337

Drug

SLV337 400 mg/day

Primary outcomes

  1. Change from Baseline in alanine amino transferase level to Day 35

    Time frame: 35 days

  2. Change from baseline in Creatinine level to Day 35

    Time frame: 35 days

  3. Change from baseline in the count of Red blood cells to Day 35

    Time frame: 35 days

  4. Change from baseline in White blood cells count to Day 35

    Time frame: 35 days

  5. Change from baseline in Creatinine kinase level to Day 35

    Time frame: 35 days

Secondary outcomes

  1. Change from baseline in Fasting plasma glucose level to Day 28

    Time frame: 28 days

  2. Change from baseline in Adiponectin level to Day 28

    Time frame: 28 days

  3. Change from baseline in Triglycerides level to Day 28

    Time frame: 28 days

  4. Change from baseline in High density lipoprotein cholesterol level to Day 28

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Abbott Products

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 19, 2009
Registry last updated
Jan 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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