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

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-ascending-dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of R1511 in Type 2 Diabetic (T2D) Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00517465

Enrollment

Registered

2007-08-17

Start date

2007-09-30

Completion date

2009-03-31

Last updated

2016-11-02

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

Conditions

Diabetes Mellitus Type 2

Brief summary

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.

Interventions

DRUGPlacebo

po bid

DRUGRG1511

Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
AEs, laboratory parameters, vital signs.	Throughout study
Glucose AUC	Days -1, 1 and 8.

Secondary

Measure	Time frame
Insulin, C-peptide, glucagon and GLP-1 AUC	Days -1, 1 and 8
24h glucose	Days -1, 1 and 8
Lipid profiles	Days -1 and 8
Pharmacokinetic parameters	Days 1 and 8

Countries

Germany, Hungary, Slovakia, United Kingdom

Outcome results

None listed

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