A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00823680

Enrollment

110

Registered

2009-01-16

Start date

2009-04-30

Completion date

2009-08-31

Last updated

2016-07-28

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 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is \< 3 months, and the target sample size is 100-500 individuals.

Interventions

DRUGPlacebo

po bid for 4 weeks

DRUGRO5027838

200mg po qd for 4 weeks

DRUGRO5093151

400mg po bid for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

Inclusion criteria

* adult patients, 35-65 years of age; * type 2 diabetes for \>=3 months; * treated for \>=3 months with stable dose of metformin \>=1.5g/day or maximum tolerated dose.

Exclusion criteria

* history of diabetic ketoacidosis; * currently or previously treated with insulin; * currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist; * treated with lipoprotein-modifying therapy within a month before screening.

Design outcomes

Primary

Measure	Time frame
Absolute change in mean daily plasma glucose	From baseline to day 27

Secondary

Measure	Time frame
Fasting plasma glucose	Baseline, and weeks 1, 2, 3 and 4
Post-prandial glucose and insulin	Baseline, weeks 2 and 4
Insulin sensitivity, beta cell function, lipid profile, HbA1C	At baseline, and at planned visits up to week 4
Adverse events, lab parameters, vital signs, body weight	At baseline, and at planned visits up to week 4

Countries

Austria, Germany, United States

Outcome results

None listed

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