A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.

A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00682097

Enrollment

Registered

2008-05-22

Start date

2008-05-31

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 study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Interventions

DRUGRO4998452

Escalating oral doses

DRUGplacebo

Oral doses

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 diabetes; * either treated by diet and exercise alone or with metformin.

Exclusion criteria

* type 1 diabetes mellitus; * uncontrolled hypertension; * clinically severe diabetic complications.

Design outcomes

Primary

Measure	Time frame
AEs, laboratory parameters, vital signs.	Throughout study
AUC0-24h, Cmax	Days 1 and 14

Secondary

Measure	Time frame
Parameters of glucose metabolism	Throughout study

Countries

Germany, United States

Outcome results

None listed

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