NCT00924534
Completed
Phase 2
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
Abbott Products12 sites in 3 countries61 target enrollmentDecember 2009
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Type 2 Diabetes
- Sponsor
- Abbott Products
- Enrollment
- 61
- Locations
- 12
- Primary Endpoint
- Change from Baseline in alanine amino transferase level to Day 35
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Intervention: Placebo
2
Intervention: SLV337
3
Intervention: SLV337
4
Intervention: SLV337
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Study Sites (12)
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