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Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

NCT ID: NCT00121641

Last Updated: 2015-04-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1035 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

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Detailed Description

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All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Saxagliptin 2.5 mg (A)

Metformin 500-2000 mg (as needed for rescue)

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\])

Placebo matching Metformin

Intervention Type DRUG

Tablets, Oral, 0 mg, daily (42 months LT)

Metformin

Intervention Type DRUG

Tablets, Oral, 500-2000 mg (as needed for rescue)

Saxagliptin 5 mg (B)

Metformin 500-2000 mg (as needed for rescue)

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)

Placebo matching Metformin

Intervention Type DRUG

Tablets, Oral, 0 mg, daily (42 months LT)

Metformin

Intervention Type DRUG

Tablets, Oral, 500-2000 mg (as needed for rescue)

Saxagliptin 10 mg (C)

Metformin 500-2000 mg (as needed for rescue)

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)

Placebo matching Metformin

Intervention Type DRUG

Tablets, Oral, 0 mg, daily (42 months LT)

Metformin

Intervention Type DRUG

Tablets, Oral, 500-2000 mg (as needed for rescue)

Placebo (D)

Metformin 500-2000 mg (as needed for rescue)

Group Type PLACEBO_COMPARATOR

Placebo matching Saxagliptin

Intervention Type DRUG

Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)

Metformin

Intervention Type DRUG

Tablets, Oral, 500 mg, daily (42 months LT)

Metformin

Intervention Type DRUG

Tablets, Oral, 500-2000 mg (as needed for rescue)

Open-Label Treatment Cohort (Direct Enrollees) (E)

Saxagliptin 10 mg

Metformin 500-2000 mg (as needed for rescue)

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label

Metformin

Intervention Type DRUG

Tablets, Oral, 500-2000 mg (as needed for rescue)

Interventions

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Saxagliptin

Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\])

Intervention Type DRUG

Saxagliptin

Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)

Intervention Type DRUG

Saxagliptin

Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)

Intervention Type DRUG

Placebo matching Saxagliptin

Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)

Intervention Type DRUG

Metformin

Tablets, Oral, 500 mg, daily (42 months LT)

Intervention Type DRUG

Placebo matching Metformin

Tablets, Oral, 0 mg, daily (42 months LT)

Intervention Type DRUG

Saxagliptin

Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label

Intervention Type DRUG

Metformin

Tablets, Oral, 500-2000 mg (as needed for rescue)

Intervention Type DRUG

Other Intervention Names

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BMS-477118 BMS-477118 BMS-477118 BMS-477118

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus
* Drug naive
* Hemoglobin (Hb) A1c \>= 7.0% and \<= 10.0% (\>10% and \<= 12% for open label arm)
* Fasting C-peptide \>= 1 ng/mL
* Body mass index \<= 40 kg/m2

Exclusion Criteria

* Symptomatic poorly controlled diabetes
* Recent cardiac or cerebrovascular event
* Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for Women of Child Bearing Potential
Minimum Eligible Age

18 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Local Institution

Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Calera, Alabama, United States

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Jonesboro, Arizona, United States

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Mesa, Arizona, United States

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Pheonix, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Rolling Hills Estates, California, United States

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Sacramento, California, United States

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Santa Ana, California, United States

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Spring Valley, California, United States

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Tustin, California, United States

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Castle Rock, Colorado, United States

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Denver, Colorado, United States

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Loveland, Colorado, United States

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Altamonte Springs, Florida, United States

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Chipley, Florida, United States

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Cocoa Beach, Florida, United States

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Coral Gables, Florida, United States

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Fort Lauderdale, Florida, United States

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Jupiter, Florida, United States

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Kissimmee, Florida, United States

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Marianna, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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West Palm Beach, Florida, United States

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Vernon Hills, Illinois, United States

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Dubuque, Iowa, United States

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Iowa City, Iowa, United States

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Waterloo, Iowa, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Munfordville, Kentucky, United States

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New Orleans, Louisiana, United States

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West Monroe, Louisiana, United States

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Baltimore, Maryland, United States

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Chester, Maryland, United States

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Prince Frederick, Maryland, United States

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Ayer, Massachusetts, United States

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Boston, Massachusetts, United States

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Rolling Fork, Mississippi, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Middletown, New Jersey, United States

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Toms River, New Jersey, United States

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Cooperstown, New York, United States

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Greensboro, North Carolina, United States

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Huntersville, North Carolina, United States

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Sparta, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Athens, Ohio, United States

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Franklin, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Fleetwood, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Bristol, Tennessee, United States

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Morristown, Tennessee, United States

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Bryan, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Texarkana, Texas, United States

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The Colony, Texas, United States

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Salt Lake City, Utah, United States

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Virginia Beach, Virginia, United States

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Olympia, Washington, United States

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Sydney, New South Wales, Australia

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Woollongong, New South Wales, Australia

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Brisbane, Queensland, Australia

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Kippa-Ring, Queensland, Australia

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Meadowbrook, Queensland, Australia

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Adelaide, South Australia, Australia

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Woodville South, South Australia, Australia

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Perth, Western Australia, Australia

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Quesnel, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Portage la Prairie, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Bathurst, New Brunswick, Canada

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Moncton, New Brunswick, Canada

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Manuels, Newfoundland and Labrador, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Newmarket, Ontario, Canada

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Oakville, Ontario, Canada

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Peterborough, Ontario, Canada

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Sarnia, Ontario, Canada

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Strathroy, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Drummondville, Quebec, Canada

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Fleurimont, Quebec, Canada

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Gatineau, Quebec, Canada

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Granby, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Aguascalientes, Aguascalientes, Mexico

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Durango, Durango, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Hermosillo, Sonora, Mexico

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Carolina, , Puerto Rico

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Guaynabo, , Puerto Rico

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

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San Juan, , Puerto Rico

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Hualien City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Countries

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United States Australia Canada Mexico Puerto Rico Taiwan

References

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Rosenstock J, Aguilar-Salinas C, Klein E, Nepal S, List J, Chen R; CV181-011 Study Investigators. Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes. Curr Med Res Opin. 2009 Oct;25(10):2401-11. doi: 10.1185/03007990903178735.

Reference Type BACKGROUND
PMID: 19650754 (View on PubMed)

Esu E, Berens-Riha N, Pritsch M, Nwachuku N, Loescher T, Meremikwu M. Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria. Malar J. 2018 Jul 6;17(1):251. doi: 10.1186/s12936-018-2394-2.

Reference Type DERIVED
PMID: 29976228 (View on PubMed)

Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

Reference Type DERIVED
PMID: 27402391 (View on PubMed)

Bonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.

Reference Type DERIVED
PMID: 27033025 (View on PubMed)

Rosenstock J, Gross JL, Aguilar-Salinas C, Hissa M, Berglind N, Ravichandran S, Fleming D. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes. Diabet Med. 2013 Dec;30(12):1472-6. doi: 10.1111/dme.12267. Epub 2013 Jul 19.

Reference Type DERIVED
PMID: 23802840 (View on PubMed)

Other Identifiers

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CV181-011

Identifier Type: -

Identifier Source: org_study_id

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