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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00823680

Collaborator

(none)

110

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Drug: Placebo Drug: RO5027838 Drug: RO5027838 Drug: RO5093151 Drug: RO5093151	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo po bid for 4 weeks
Experimental: RO5027838 200mg	Drug: RO5027838 200mg po qd for 4 weeks
Experimental: RO5027838 50mg	Drug: RO5027838 50mg po bid for 4 weeks
Experimental: RO5093151 10mg	Drug: RO5093151 10mg po bid for 4 weeks
Experimental: RO5093151 400mg	Drug: RO5093151 400mg po bid for 4 weeks

Outcome Measures

Primary Outcome Measures

Absolute change in mean daily plasma glucose [From baseline to day 27]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Chula Vista	California	United States	91911
2	Miami	Florida	United States	330014
3	Graz		Austria	8036
4	München		Germany	80636
5	Neuss		Germany	41460

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00823680

Other Study ID Numbers:

BP21850
2008-001122-13

First Posted:

Jan 16, 2009

Last Update Posted:

Jul 28, 2016

Last Verified:

Jul 1, 2016

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 28, 2016