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SLV337

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Abbott Laboratories|Last Updated: Jan 4, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

SLV337 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00924534A Safety PK/PD Study of SLV337 in Patients With Type 2 DiabetesType 2 Diabetes
COMPLETED61 Analytics
PHASE2COMPLETED
A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

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
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)
Part 1: 5 days Part 2: 8 days
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)
Part 2: 8 days
Excretion balance of total 14C-radioactivity (Part 2)
Part 2: 8 days
Total 14C-radioactivity (Part 2)
Part 2: 8 days
Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)
Part 2: 8 days

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
AEXPERIMENTAL400 mg suspension
BACTIVE_COMPARATOR5 x 200 mg immediate release capsule

Interventions

NameTypeDescription
PlaceboDRUGPlacebo
SLV337DRUGSLV337 400 mg/day
SLV337 suspensionDRUG400 mg experimental
SLV337 capsuleDRUG5 x 200 mg immediate release capsule
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

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

Countries:BulgariaPolandSouth AfricaNetherlands
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Frequently asked questions about SLV337

What is SLV337 used for?

SLV337 is an investigational small molecule being studied for use in Type 2 Diabetes and in healthy subjects. It has been evaluated in clinical trials for these conditions, including a safety, pharmacokinetic, and pharmacodynamic study in patients with Type 2 Diabetes.

Who is developing SLV337?

SLV337 is being developed by Abbott Laboratories, which trades under the ticker ABT. The company has sponsored clinical trials of the drug in patients with Type 2 Diabetes and in healthy subjects.

What phase is SLV337 in?

SLV337 is an investigational drug that has completed clinical trials. One trial was a Phase 1 study in healthy subjects, and another was a Phase 2 study in patients with Type 2 Diabetes. Both trials are completed, and the drug remains in clinical development.

What clinical trials is SLV337 in?

SLV337 has been studied in two completed clinical trials. NCT00924534 was a Phase 2 safety, pharmacokinetic, and pharmacodynamic study in 61 patients with Type 2 Diabetes in Bulgaria, Poland, and South Africa. NCT01176201 was a Phase 1 ADME study in 12 healthy male subjects in the Netherlands.

Is SLV337 the same as any other drug?

SLV337 is the drug name used in its clinical trials. No alternative names for SLV337 have been identified in the available trial information.