NCT00823680

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

January 15, 2009

Last Update Submit

July 26, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Absolute change in mean daily plasma glucose

    From baseline to day 27

Secondary Outcomes (4)

  • 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

RO5027838 200mg

EXPERIMENTAL
Drug: RO5027838

RO5027838 50mg

EXPERIMENTAL
Drug: RO5027838

RO5093151 10mg

EXPERIMENTAL
Drug: RO5093151

RO5093151 400mg

EXPERIMENTAL
Drug: RO5093151

Interventions

PlaceboDRUG

po bid for 4 weeks

Placebo
RO5027838DRUG

200mg po qd for 4 weeks

RO5027838 200mg
RO5093151DRUG

400mg po bid for 4 weeks

RO5093151 400mg

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Chula Vista, California, 91911, United States

Location

Unknown Facility

Miami, Florida, 330014, United States

Location

Unknown Facility

Graz, 8036, Austria

Location

Unknown Facility

München, 80636, Germany

Location

Unknown Facility

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

DE(2)AU(1)US(2)