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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00924534

Enrollment

Registered

2009-06-19

Start date

2009-12-31

Completion date

2010-12-31

Last updated

2012-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, interventional, placebo, controlled, PK, PD, safety

Brief summary

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

Interventions

DRUGPlacebo

Placebo

DRUGSLV337

SLV337 400 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in Creatinine kinase level to Day 35	35 days
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

Secondary

Measure	Time frame
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
Change from baseline in Fasting plasma glucose level to Day 28	28 days

Countries

Bulgaria, Poland, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026