A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes
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
2 other identifiers
interventional
61
3 countries
12
Brief Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes
Started Dec 2009
Shorter than P25 for phase_2 type-2-diabetes
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 4, 2012
August 1, 2011
1 year
June 18, 2009
December 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (4)
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 Arms (4)
1
PLACEBO COMPARATOR2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Productslead
- Quintiles, Inc.collaborator
Study Sites (12)
Site Reference ID/Investigator# 54183
Dimitrovgrad, 6400, Bulgaria
Site Reference ID/Investigator# 54182
Pleven, 5800, Bulgaria
Site Reference ID/Investigator# 44722
Plovdiv, 4000, Bulgaria
Site Reference ID/Investigator# 44723
Sofia, 1407, Bulgaria
Site Reference ID/Investigator# 44725
Lubin, 59-301, Poland
Site Reference ID/Investigator# 44724
Puławy, 24-100, Poland
Site Reference ID/Investigator# 54185
Radzymin, 05-250, Poland
Site Reference ID/Investigator# 44727
Ruda Śląska, Poland
Site Reference ID/Investigator# 54184
Wroclaw, 50-349, Poland
Site Reference ID/Investigator# 44728
Cape Town, 7130, South Africa
Site Reference ID/Investigator# 44730
Cape Town, 7937, South Africa
Site Reference ID/Investigator# 44729
Johannesburg, 2198, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francis Roy, MS
Abbott Products
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2009
First Posted
June 19, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 4, 2012
Record last verified: 2011-08