Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

NCT00290940 | Completed Phase 2

• 1 other identifier: CS0917-A-U205
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 66

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus, Type 2; High blood sugar; Hyperglycemia; Antihyperglycemic agents; CS-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-917 DRUG

metformin hydrochloride DRUG

pioglitazone DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (66)

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Birmingham, Alabama, 35205, United States

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Northport, Alabama, 35476, United States

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Mesa, Arizona, 85201, United States

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Phoenix, Arizona, 85014, United States

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Tempe, Arizona, 85282, United States

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Hot Springs, Arkansas, 71913, United States

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Cudahy, California, 90201, United States

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Long Beach, California, 90806, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95841, United States

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Spring Valley, California, 91978, United States

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Studio City, California, 91604, United States

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Vista, California, 92083, United States

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Walnut Creek, California, 94598, United States

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West Hills, California, 91307, United States

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Wilmington, Delaware, 19805, United States

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Brooksville, Florida, 34613, United States

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Fort Lauderdale, Florida, 33308, United States

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Kissimmee, Florida, 34741, United States

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Miami, Florida, 33156, United States

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Pembroke Pines, Florida, 33028, United States

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Sebastian, Florida, United States

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St. Petersburg, Florida, 33709, United States

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Tallahassee, Florida, 32308, United States

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West Palm Beach, Florida, 33401, United States

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Rome, Georgia, United States

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Warner Robins, Georgia, 31093, United States

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Shawnee Mission, Kansas, 66216, United States

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Topeka, Kansas, 66614, United States

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Topeka, Kansas, United States

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Oxon Hill, Maryland, 20745, United States

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Cadillac, Michigan, 49601, United States

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Detroit, Michigan, 48235, United States

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Interlochen, Michigan, 49643, United States

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Livonia, Michigan, 48152, United States

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Port Gibson, Mississippi, 39150, United States

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Rolling Fork, Mississippi, 39159, United States

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Excelsior Springs, Missouri, 64024, United States

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Henderson, Nevada, 89052, United States

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Las Vegas, Nevada, 89103, United States

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Elizabeth, New Jersey, 07202, United States

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Toms River, New Jersey, 08755, United States

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Charlotte, North Carolina, 28262, United States

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Lenoir, North Carolina, 28645, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Delaware, Ohio, 43015, United States

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Marion, Ohio, 43302, United States

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Oklahoma City, Oklahoma, 73103, United States

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Beaver, Pennsylvania, 15009, United States

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Bensalem, Pennsylvania, 19020, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Reading, Pennsylvania, 19696, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Nashville, Tennessee, United States

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Corpus Christi, Texas, 78404, United States

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Houston, Texas, 77024, United States

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Lake Jackson, Texas, 77566, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, 78229, United States

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Burke, Virginia, United States

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Olympia, Washington, 98502, United States

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Madison, Wisconsin, 53719, United States

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

N,N'-((5-(2-amino-5-(2-methylpropyl)-4-thiazolyl)-2-furanyl)phosphinylidene)bis(alanine) diethyl ester; Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 1, 2006
• Study Completion: April 1, 2007
• Last Updated: September 11, 2007

Record last verified: 2007-09

Locations

US (66)