A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: RG1511

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517465

NP20945

Details and patient eligibility

About

This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-65 years of age;
• type 2 diabetic patients;
• naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.

Exclusion criteria

• type 1 diabetes mellitus;
• clinically significant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RG1511

2

Experimental group

Treatment:

Drug: RG1511

3

Experimental group

Treatment:

Drug: RG1511

4

Placebo Comparator group

Treatment:

Drug: Placebo