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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: SLV337; Drug: Placebo

• Registration Number: NCT00924534
• Lead Sponsor: Abbott Products

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Study Start: 2009-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-12-30
• Last Update Posted: 2012-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	SLV337	-
1	Placebo	-
2	SLV337	-
4	SLV337	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in alanine amino transferase level to Day 35	35 days
Change from baseline in Creatinine level to Day 35	35 days
Change from baseline in the count of Red blood cells to Day 35	35 days
Change from baseline in White blood cells count to Day 35	35 days
Change from baseline in Creatinine kinase level to Day 35	35 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Fasting plasma glucose level to Day 28	28 days
Change from baseline in Adiponectin level to Day 28	28 days
Change from baseline in Triglycerides level to Day 28	28 days
Change from baseline in High density lipoprotein cholesterol level to Day 28	28 days

Trial Locations

Locations (12)

Site Reference ID/Investigator# 44722; 🇧🇬 Plovdiv, Bulgaria

Site Reference ID/Investigator# 54183; 🇧🇬 Dimitrovgrad, Bulgaria

Site Reference ID/Investigator# 44723; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 44725; 🇵🇱 Lubin, Poland

Site Reference ID/Investigator# 54185; 🇵🇱 Radzymin, Poland

Site Reference ID/Investigator# 54184; 🇵🇱 Wroclaw, Poland

Site Reference ID/Investigator# 44727; 🇵🇱 Ruda Slaska, Poland

Site Reference ID/Investigator# 54182; 🇧🇬 Pleven, Bulgaria

Site Reference ID/Investigator# 44724; 🇵🇱 Pulawy, Poland

Site Reference ID/Investigator# 44728; 🇿🇦 Cape Town, South Africa

Site Reference ID/Investigator# 44730; 🇿🇦 Cape Town, South Africa

Site Reference ID/Investigator# 44729; 🇿🇦 Johannesburg, South Africa