A Study of RO6811135 in Patients With Type 2 Diabetes Who... | NCT01951183

Studies
A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin

NCT01951183

Sponsor

Hoffmann-La Roche

Status

Withdrawn

Last Update Posted

Nov 2, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Diabetes Mellitus Type 2

Interventions

Placebo
RO6811135

Countries

Not provided

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Cancelled due to Sponsor's decision

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 23, 2013

First Submission Date that Met QC Criteria

Sep 23, 2013

First Posted Date

Sep 26, 2013Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
RO6811135	Experimental		Drug: RO6811135

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	RO681135 placebo subcutaneously daily	Placebo
RO6811135

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c		from baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in fasting plasma glucose (FPG)		from baseline to Week 12
Pharmacokinetics: Area under the concentration-time curve (AUC)		12 weeks
Safety: Incidence of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults between the age of 18 and 65
Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
Hemoglobin A1c between 7.2 and 10.5%
Fasting plasma glucose less than 250 mg/dL
C-peptide greater than 1.5 ng/mL
Body mass index (BMI) between 27 and 44

Exclusion Criteria:

Pregnant or lactating women
Type 1 diabetes
Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
Significant kidney or liver disease as determined by the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

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