Clinical trial NCT00924534: A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
interventional
placebo
controlled
PK
PD
safety
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-06-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from Baseline in alanine amino transferase level to Day 35
timeFrame: 35 days
measure: Change from baseline in Creatinine level to Day 35
timeFrame: 35 days
measure: Change from baseline in the count of Red blood cells to Day 35
timeFrame: 35 days
measure: Change from baseline in White blood cells count to Day 35
timeFrame: 35 days
measure: Change from baseline in Creatinine kinase level to Day 35
timeFrame: 35 days
Secondary outcomes:
measure: Change from baseline in Fasting plasma glucose level to Day 28
timeFrame: 28 days
measure: Change from baseline in Adiponectin level to Day 28
timeFrame: 28 days
measure: Change from baseline in Triglycerides level to Day 28
timeFrame: 28 days
measure: Change from baseline in High density lipoprotein cholesterol level to Day 28
timeFrame: 28 days
Other outcomes:
Locations:
city: Dimitrovgrad
country: Bulgaria
facility: Site Reference ID/Investigator# 54183
city: Pleven
country: Bulgaria
facility: Site Reference ID/Investigator# 54182
city: Plovdiv
country: Bulgaria
facility: Site Reference ID/Investigator# 44722
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 44723
city: Lubin
country: Poland
facility: Site Reference ID/Investigator# 44725
city: Pulawy
country: Poland
facility: Site Reference ID/Investigator# 44724
city: Radzymin
country: Poland
facility: Site Reference ID/Investigator# 54185
city: Ruda Slaska
country: Poland
facility: Site Reference ID/Investigator# 44727
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 54184
city: Cape Town
country: South Africa
facility: Site Reference ID/Investigator# 44728
city: Cape Town
country: South Africa
facility: Site Reference ID/Investigator# 44730
city: Johannesburg
country: South Africa
facility: Site Reference ID/Investigator# 44729
Study officials:
affiliation: Abbott Products
name: Francis Roy, MS
role: STUDY_DIRECTOR
References: