A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: GK Activator (2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00368368

NP19470

Details and patient eligibility

About

This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years of age;
• type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2);
• normal renal function, or moderate or severe impairment.

Exclusion criteria

• type 1 diabetes;
• treatment with insulin or PPAR gamma agonist within 6 months of screening.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: GK Activator (2)

2

Experimental group

Treatment:

Drug: GK Activator (2)

3

Experimental group

Treatment:

Drug: GK Activator (2)