Study of RO6807952 in Patients With Diabetes Mellitus Type 2 | NCT01516476

Studies
Study of RO6807952 in Patients With Diabetes Mellitus Type 2

NCT01516476

Sponsor

Hoffmann-La Roche

Status

Terminated

Last Update Posted

Nov 2, 2016Estimated

Enrollment

2Actual

Phase

Phase 2

Conditions

Diabetes Mellitus Type 2

Interventions

Placebo
RO6807952
RO6807952
liraglutide

Countries

United States

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

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jan 12, 2012

First Submission Date that Met QC Criteria

Jan 19, 2012

First Posted Date

Jan 24, 2012Estimated

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 8, 2016

Certification/Extension First Submitted that Passed QC Review

Jul 8, 2016

Certification/Extension First Posted Date

Jul 12, 2016Estimated

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.

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

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Liraglutide Arm	Experimental	Drug: liraglutide
Placebo Arm	Placebo Comparator	Drug: Placebo
RO6807952 Arm 1	Experimental	Drug: RO6807952
RO6807952 Arm 2	Experimental	Drug: RO6807952

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo for 12 weeks	Placebo Arm
RO6807952

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in hemoglobin A1c (HA1c)		Baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in fasting plasma glucose		Baseline and 12 weeks
Safety (incidence of adverse events)		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients >/= 18 and </=70 years of age
Diagnosis of diabetes mellitus, type 2 for at least 3 months
Treated with a stable dose of metformin
Hemoglobin A1c >/=7.0% and </=10.5% at screening
Fasting plasma glucose </=240 mg/dL at screening
Body mass index >/=27 kg/m2 and </=42 kg/m2 at screening
Willing and able to maintain existing diet and exercise habits throughout the study
C-peptide >1.5 ng/mL at screening

Exclusion Criteria:

History of significant liver or kidney disease
History of uncontrolled hypertension
History of significant cardiovascular disease
History of significant diabetic complications
History of significant gastrointestinal conditions
History of weight loss surgery or procedures involving the gastrointestinal tract
History of chronic or acute pancreatitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
		Cincinnati	Ohio	45227	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

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

Browse Leaves

Not provided

Browse Branches

Not provided