A Comparison of SLx-4090 in Combination With Metformin Ve... | NCT00871936 | Trialant

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A Comparison of SLx-4090 in Combination With Metformin Ve... | NCT00871936 | Trialant

Studies
A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

NCT00871936

Sponsor

Response Pharmaceuticals

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

82Actual

Phase

Phase 2

Conditions

Type 2 Diabetes

Interventions

SLx-4090
Placebo
Metformin

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

NCT00871936

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

SLx-4090-09-07

Secondary IDs

Not provided

Brief Title

A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of SLx-4090 in Combination With Metformin in Subjects With Type 2 Diabetes

Acronym

Not provided

Organization

Response PharmaceuticalsINDUSTRY

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Apr 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Mar 26, 2009

First Posted Date

Mar 30, 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

Dec 9, 2014

Certification/Extension First Submitted that Passed QC Review

Dec 9, 2014

Certification/Extension First Posted Date

Dec 31, 2014Estimated

Last Update Submitted Date

Nov 14, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Response PharmaceuticalsINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

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 determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.

Detailed Description

HbA1c after 12 weeks
FPG after 12 weeks
Safety and tolerability
Plasma levels of SLx-4090

Conditions Module

Conditions

Type 2 Diabetes

Keywords

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

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	SLx-4090 in combination with Metformin	Drug: SLx-4090 Drug: Metformin
2	Other	Placebo	Other: Placebo Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SLx-4090	Drug	SLx-4090	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in HbA1c		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HbA1c 7-11%
On a stable dose of metformin for at least 6 weeks

Exclusion Criteria:

Type 1 Diabetes
Antidiabetic medication other than or in addition to metformin
FPG > 270 mg/dL

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Anaheim	California	92801	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

ParticipantInvestigator

Other

matching tablets

2

Metformin

Drug

1
2

Burbank

California

91505

United States

Los Angeles

California

90036

United States

Los Angeles

California

90057

United States

West Palm Beach

Florida

33401

United States

Addison

Illinois

60101

United States

Auburn

Maine

04210

United States

Charlotte

North Carolina

28211

United States

Hickory

North Carolina

28602

United States

Winston-Salem

North Carolina

27103

United States

Greenville

South Carolina

29615

United States

San Antonio

Texas

78229

United States

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
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C559489	6-(4'-trifluoromethyl-6-methoxybiphenyl-2-ylcarboxamido)-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid phenyl ester
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided