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

Abbott

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: SLV337; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924534

S337.2.001

2009-011589-27 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

61 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: SLV337

Drug: SLV337

Drug: SLV337

3

Experimental group

Treatment:

Drug: SLV337

Drug: SLV337

Drug: SLV337

4

Experimental group

Treatment:

Drug: SLV337

Drug: SLV337

Drug: SLV337