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

Abbott Products61 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

PlaceboDRUG

Placebo

SLV337DRUG

SLV337 400 mg/day

SLV337DRUG

SLV337 800 mg/day

SLV337DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

Site Reference ID/Investigator# 54183

Dimitrovgrad, Bulgaria

Site Reference ID/Investigator# 54182

Pleven, Bulgaria

Site Reference ID/Investigator# 44722

Plovdiv, Bulgaria

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

Time frame: 28 days

Change from baseline in Adiponectin level to Day 28

Time frame: 28 days

Change from baseline in Triglycerides level to Day 28

Time frame: 28 days

Change from baseline in High density lipoprotein cholesterol level to Day 28

Time frame: 28 days

Data from ClinicalTrials.gov

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