A Study of Taspoglutide in Patients With Inadequately Con... | NCT01018173

Studies
A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

NCT01018173

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

2,118Actual

Phase

Phase 3

Conditions

Diabetes Mellitus Type 2

Interventions

placebo
taspoglutide

Countries

United States
Australia
Brazil
Bulgaria
Canada
Czechia
Denmark
Estonia
Germany
Hungary
India
Israel
Lithuania
Malaysia
Mexico
Poland
Romania
Russia
Slovakia
South Africa
Spain
Taiwan
Thailand
Ukraine
United Kingdom

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

ID	Type	Description	Link
2009-014986-22

Status Module

Record Verification Date

Nov 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

Jan 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Nov 20, 2009

First Submission Date that Met QC Criteria

Nov 20, 2009

First Posted Date

Nov 23, 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 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 parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator		Drug: placebo
taspoglutide	Experimental		Drug: taspoglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	sc weekly	placebo
taspoglutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to cardiovascular composite primary endpoints		event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

Secondary Outcomes

Measure	Description	Time Frame
Secondary cardiovascular composite endpoints		event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Individual components of primary cardiovascular composite endpoints		event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients, >18 years of age
diabetes mellitus type 2
HbA1c >/=6.5% and </=10% at screening
BMI >/=23kg/m2
cardiovascular disease with onset >/=1 month prior to screening

Exclusion Criteria:

diagnosis or history of type 1 diabetes or secondary forms of diabetes
acute metabolic diabetic complications within past 6 months
severe hypoglycemia \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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
		Phoenix	Arizona	85050	United States

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases