NCT00290940

CompletedPhase 2

Evaluation of Glucose Lowering Effect, Safety and Tolerabili...

Daiichi Sankyo Source

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Other study identifiers

Sponsor study identifier

CS0917-A-U205

Study Type

interventional

Estimated enrollment

400

Locations

1 country

Sites

66

Timeline

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 2007

Actual (reported)

Brief Summary

This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 400 participants
Study completion date: April 2007
Actual (reported)
Listed locations: 1 countries · 66 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 10, 2006
Actual (reported)
First Posted
February 13, 2006
Actual (reported)
Study Completion
April 2007
Actual (reported)

Last Updated: September 11, 2007
Status Verified: September 2007
Last Update Submitted: September 10, 2007

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus, Type 2High blood sugarHyperglycemiaAntihyperglycemic agentsCS-917

Outcome Measures

Primary Outcomes (1)

Mean change from baseline in HbA1C after 12 weeks compared to placebo

Secondary Outcomes (5)

Onset of efficacy of CS-917
Safety and tolerability of CS-917
Changes in other relevant glycemic and metabolic measures
Proportion of subjects achieving therapeutic response
Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia

Interventions

CS-917Drug

metformin hydrochlorideDrug

pioglitazoneDrug

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Drug naive or newly diagnosed type 2 diabetic subjects:
Never received oral antihyperglycemic or insulin therapy or

Sponsors & Collaborators

Daiichi Sankyo
Industrylead

Study Sites (66)

Birmingham, Alabama, 35205, United States

Northport, Alabama, 35476, United States

Mesa, Arizona, 85201, United States

Phoenix, Arizona, 85014, United States

Tempe, Arizona, 85282, United States

Hot Springs, Arkansas, 71913, United States

Cudahy, California, 90201, United States

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Interventions

N,N'-((5-(2-amino-5-(2-methylpropyl)-4-thiazolyl)-2-furanyl)phosphinylidene)bis(alanine) diethyl esterMetforminPioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidines

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

April 2007

Actual (reported)

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Phase 2Terminated

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Phase 2Completed

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Phase 2Completed

NCT01103414

Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients

Phase 2Completed

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Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

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Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics

Phase 2Terminated

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and

No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and

No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.

HbA1C\>6.7% and \< or = to 10% at screening

You may not qualify if:

Current insulin therapy
Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
Serum bicarbonate \< or = to 19 meq/L
Serum creatinine (Scr) \> 1.4 mg/dL (females) or 1.5 mg/dL (males)
Contraindication to metformin

Contact the study team to confirm eligibility.

Long Beach, California, 90806, United States

Roseville, California, 95661, United States

Sacramento, California, 95841, United States

Spring Valley, California, 91978, United States

Studio City, California, 91604, United States

Vista, California, 92083, United States

Walnut Creek, California, 94598, United States

West Hills, California, 91307, United States

Wilmington, Delaware, 19805, United States

Brooksville, Florida, 34613, United States

Fort Lauderdale, Florida, 33308, United States

Kissimmee, Florida, 34741, United States

Miami, Florida, 33156, United States

Pembroke Pines, Florida, 33028, United States

Sebastian, Florida, United States

St. Petersburg, Florida, 33709, United States

Tallahassee, Florida, 32308, United States

West Palm Beach, Florida, 33401, United States

Rome, Georgia, United States

Warner Robins, Georgia, 31093, United States

Shawnee Mission, Kansas, 66216, United States

Topeka, Kansas, 66614, United States

Topeka, Kansas, United States

Oxon Hill, Maryland, 20745, United States

Cadillac, Michigan, 49601, United States

Detroit, Michigan, 48235, United States

Interlochen, Michigan, 49643, United States

Livonia, Michigan, 48152, United States

Port Gibson, Mississippi, 39150, United States

Rolling Fork, Mississippi, 39159, United States

Excelsior Springs, Missouri, 64024, United States

Henderson, Nevada, 89052, United States

Las Vegas, Nevada, 89103, United States

Elizabeth, New Jersey, 07202, United States

Toms River, New Jersey, 08755, United States

Charlotte, North Carolina, 28262, United States

Lenoir, North Carolina, 28645, United States

Raleigh, North Carolina, 27612, United States

Winston-Salem, North Carolina, 27103, United States

Cincinnati, Ohio, 45219, United States

Delaware, Ohio, 43015, United States

Marion, Ohio, 43302, United States

Oklahoma City, Oklahoma, 73103, United States

Beaver, Pennsylvania, 15009, United States

Bensalem, Pennsylvania, 19020, United States

Pittsburgh, Pennsylvania, 15206, United States

Reading, Pennsylvania, 19696, United States

Anderson, South Carolina, 29621, United States

Charleston, South Carolina, United States

Greer, South Carolina, United States

Nashville, Tennessee, United States

Corpus Christi, Texas, 78404, United States

Houston, Texas, 77024, United States

Lake Jackson, Texas, 77566, United States

North Richland Hills, Texas, United States

San Antonio, Texas, 78229, United States

Burke, Virginia, United States

Olympia, Washington, 98502, United States

Madison, Wisconsin, 53719, United States

Amidines

Organic Chemicals

Thiazolidinediones

Thiazoles

Sulfur Compounds

Azoles

Heterocyclic Compounds, 1-Ring

Heterocyclic Compounds

Last Updated

September 11, 2007

Record last verified: 2007-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00290940
Data provider: ClinicalTrials.gov
Source updated: 2007-09-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:35 UTC

Locations

US(66)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations