A Study of RO5093151 and RO5027838 in Patients With Type... | NCT00823680

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

NCT00823680

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Jul 28, 2016Estimated

Enrollment

110Actual

Phase

Phase 2

Conditions

Diabetes Mellitus Type 2

Interventions

Placebo
RO5027838
RO5027838
RO5093151
RO5093151

Countries

United States
Austria
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-001122-13

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

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jan 15, 2009

First Submission Date that Met QC Criteria

Jan 15, 2009

First Posted Date

Jan 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jul 26, 2016

Certification/Extension First Submitted that Passed QC Review

Jul 26, 2016

Certification/Extension First Posted Date

Jul 28, 2016Estimated

Last Update Submitted Date

Jul 26, 2016

Last Update Posted Date

Jul 28, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	po bid for 4 weeks	Placebo
RO5027838

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Chula Vista	California	91911	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided