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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00924534
First received: June 18, 2009
Last updated: December 30, 2011
Last verified: August 2011
  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 Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change from Baseline in alanine amino transferase level to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in Creatinine level to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • Change from baseline in the count of Red blood cells to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • Change from baseline in White blood cells count to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • Change from baseline in Creatinine kinase level to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Fasting plasma glucose level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline in Adiponectin level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline in Triglycerides level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline in High density lipoprotein cholesterol level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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# 44730
Cape Town, South Africa, 7937
Site Reference ID/Investigator# 44728
Cape Town, South Africa, 7130
Site Reference ID/Investigator# 44729
Johannesburg, South Africa, 2198
Sponsors and Collaborators
Abbott Products
Quintiles
Investigators
Study Director: Francis Roy, MS Abbott Products
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT00924534     History of Changes
Other Study ID Numbers: S337.2.001, 2009-011589-27
Study First Received: June 18, 2009
Last Updated: December 30, 2011
Health Authority: South Africa: Medicines Control Council
Bulgaria: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Poland: The Central Register of Clinical Trials
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Abbott:
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

ClinicalTrials.gov processed this record on April 17, 2014