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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924534
• Other study ID #: S337.2.001
• Secondary ID: 2009-011589-27
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2009
• Last updated: December 30, 2011
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilBulgaria: Ministry of HealthBulgaria: Bulgarian Drug AgencyPoland: The Central Register of Clinical TrialsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Placebo
Placebo
• SLV337
SLV337 400 mg/day
• SLV337
SLV337 800 mg/day
• SLV337
SLV337 1400 mg/day

Locations

Country	Name	City	State
Bulgaria	Site Reference ID/Investigator# 54183	Dimitrovgrad
Bulgaria	Site Reference ID/Investigator# 54182	Pleven
Bulgaria	Site Reference ID/Investigator# 44722	Plovdiv
Bulgaria	Site Reference ID/Investigator# 44723	Sofia
Poland	Site Reference ID/Investigator# 44725	Lubin
Poland	Site Reference ID/Investigator# 44724	Pulawy
Poland	Site Reference ID/Investigator# 54185	Radzymin
Poland	Site Reference ID/Investigator# 44727	Ruda Slaska
Poland	Site Reference ID/Investigator# 54184	Wroclaw
South Africa	Site Reference ID/Investigator# 44728	Cape Town
South Africa	Site Reference ID/Investigator# 44730	Cape Town
South Africa	Site Reference ID/Investigator# 44729	Johannesburg

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Products	Quintiles, Inc.

Countries where clinical trial is conducted

Bulgaria,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in alanine amino transferase level to Day 35		35 days	Yes
Primary	Change from baseline in Creatinine level to Day 35		35 days	No
Primary	Change from baseline in the count of Red blood cells to Day 35		35 days	No
Primary	Change from baseline in White blood cells count to Day 35		35 days	No
Primary	Change from baseline in Creatinine kinase level to Day 35		35 days	No
Secondary	Change from baseline in Fasting plasma glucose level to Day 28		28 days	No
Secondary	Change from baseline in Adiponectin level to Day 28		28 days	No
Secondary	Change from baseline in Triglycerides level to Day 28		28 days	No
Secondary	Change from baseline in High density lipoprotein cholesterol level to Day 28		28 days	No