GW823093C For The Treatment Of Type 2 Diabetes Mellitus | NCT00370942

Studies
GW823093C For The Treatment Of Type 2 Diabetes Mellitus

NCT00370942

Sponsor

GlaxoSmithKline

Status

Terminated

Last Update Posted

Aug 31, 2018Actual

Enrollment

159Actual

Phase

Phase 2

Conditions

Diabetes Mellitus, Type 2

Interventions

GW823093C A
GW823093C B
GW823093C C

Countries

Japan

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Safety issue

Expanded Access Info

Start Date

Apr 1, 2006

Primary Completion Date

Nov 1, 2006Actual

Completion Date

Nov 25, 2006Actual

First Submitted Date

Aug 30, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Sep 1, 2006Estimated

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

Aug 30, 2018

Last Update Posted Date

Aug 31, 2018Actual

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

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GW823093C A	Placebo Comparator	A=45 mg	Drug: GW823093C A
GW823093C B	Placebo Comparator	B=30 mg	Drug: GW823093C B
GW823093C C	Placebo Comparator	C=15 mg	Drug: GW823093C C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GW823093C A	Drug	A=45 mg	GW823093C A
GW823093C B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Long term safety variables		64 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Type 2 diabetes mellitus.
Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))

Exclusion criteria:

Patients who have metabolic disease judged by investigator as a clinically significance
Serious cardiovascular disease or serious hepatic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 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
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Hokkaido		051-0005	Japan
GSK Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided