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
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, see Learn About Clinical Studies.

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 August 26, 2014