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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924534
First Posted: June 19, 2009
Last Update Posted: January 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Abbott ( Abbott Products )
  Purpose
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes

Condition Intervention Phase
Type 2 Diabetes Drug: Placebo Drug: SLV337 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Further study details as provided by Abbott ( Abbott Products ):

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

Secondary Outcome Measures:
  • Change from baseline in Fasting plasma glucose level to Day 28 [ Time Frame: 28 days ]
  • Change from baseline in Adiponectin level to Day 28 [ Time Frame: 28 days ]
  • Change from baseline in Triglycerides level to Day 28 [ Time Frame: 28 days ]
  • Change from baseline in High density lipoprotein cholesterol level to Day 28 [ Time Frame: 28 days ]

Enrollment: 61
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo
Experimental: 2 Drug: SLV337
SLV337 400 mg/day
Experimental: 3 Drug: SLV337
SLV337 800 mg/day
Experimental: 4 Drug: SLV337
SLV337 1400 mg/day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924534


Locations
Bulgaria
Site Reference ID/Investigator# 54183
Dimitrovgrad, Bulgaria, 6400
Site Reference ID/Investigator# 54182
Pleven, Bulgaria, 5800
Site Reference ID/Investigator# 44722
Plovdiv, Bulgaria, 4000
Site Reference ID/Investigator# 44723
Sofia, Bulgaria, 1407
Poland
Site Reference ID/Investigator# 44725
Lubin, Poland, 59-301
Site Reference ID/Investigator# 44724
Pulawy, Poland, 24-100
Site Reference ID/Investigator# 54185
Radzymin, Poland, 05-250
Site Reference ID/Investigator# 44727
Ruda Slaska, Poland
Site Reference ID/Investigator# 54184
Wroclaw, Poland, 50-349
South Africa
Site Reference ID/Investigator# 44728
Cape Town, South Africa, 7130
Site Reference ID/Investigator# 44730
Cape Town, South Africa, 7937
Site Reference ID/Investigator# 44729
Johannesburg, South Africa, 2198
Sponsors and Collaborators
Abbott Products
Quintiles, Inc.
Investigators
Study Director: Francis Roy, MS Abbott Products
  More Information

Responsible Party: Abbott Products
ClinicalTrials.gov Identifier: NCT00924534     History of Changes
Other Study ID Numbers: S337.2.001
2009-011589-27 ( EudraCT Number )
First Submitted: June 18, 2009
First Posted: June 19, 2009
Last Update Posted: January 4, 2012
Last Verified: August 2011

Keywords provided by Abbott ( Abbott Products ):
type 2 diabetes
interventional
placebo
controlled
PK
PD
safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases