Renal Mechanism of Action/Splay vs. TmG | NCT00726505

Studies
Renal Mechanism of Action/Splay vs. TmG

NCT00726505

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Oct 17, 2016Estimated

Enrollment

1Actual

Phase

Phase 1

Conditions

Diabetes, NOS

Interventions

Dapagliflozin

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

Oct 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

Jun 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jul 30, 2008

First Submission Date that Met QC Criteria

Jul 30, 2008

First Posted Date

Aug 1, 2008Estimated

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

Oct 14, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Subjects with T2DM - Dapagliflozin 5 mg	Drug: Dapagliflozin
Group 2	Active Comparator	Subjects with T2DM - Dapagliflozin 20 mg	Drug: Dapagliflozin
Group 3	Active Comparator	Healthy Subjects - Dapagliflozin 20 mg	Drug: Dapagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	Tablets, Oral, Once Daily, up to 29 days:	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in urinary glucose excretion dynamics		after 7 days of treatment

Secondary Outcomes

Measure	Description	Time Frame
Differences in urinary glucose between healthy and diabetic subjects		at 7 days
Changes in liver glucose production		at one day
Glucose effects on tubular markers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects
Age 18 to 65 years
BMI 18 to 35 kg/m2
Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
No evidence of impaired renal function

Exclusion Criteria:

Unwilling or unable to use an acceptable method of birth control
Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
Exposure to insulin
Use of exclusionary concomitant medications
Evidence of significant kidney disease or any other significant medical or psychiatric disorder

Accepts Healthy Volunteers

Yes

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Of Texas Health Center At San Antonio		San Antonio	Texas	78229	United States

Label	URL
MB102020 \_Redacted \_CSR \_synopsis	View source

Condition Browse Module

MeSH Terms

ID	Term
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

Intervention Browse Module

MeSH Terms

ID	Term
C529054	dapagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided