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Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

NCT ID: NCT00121667

Last Updated: 2015-04-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

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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 pioglitizone added onto their blinded study medication

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 + Metformin (A)

Pioglitazone 15-45 mg (as needed for rescue)

Group Type EXPERIMENTAL

Saxagliptin + Metformin

Intervention Type DRUG

Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Pioglitazone

Intervention Type DRUG

Tablets, Oral, 15 - 45 mg (as needed for rescue)

Saxagliptin + Metformin (B)

Pioglitazone 15-45 mg (as needed for rescue)

Group Type EXPERIMENTAL

Saxagliptin + Metformin

Intervention Type DRUG

Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Pioglitazone

Intervention Type DRUG

Tablets, Oral, 15 - 45 mg (as needed for rescue)

Saxagliptin + Metformin (C)

Pioglitazone 15-45 mg (as needed for rescue)

Group Type EXPERIMENTAL

Saxagliptin + Metformin

Intervention Type DRUG

Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Pioglitazone

Intervention Type DRUG

Tablets, Oral, 15 - 45 mg (as needed for rescue)

Placebo+ Metformin (D)

Pioglitazone 15-45 mg (as needed for rescue)

Group Type PLACEBO_COMPARATOR

Placebo + Metformin

Intervention Type DRUG

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

Pioglitazone

Intervention Type DRUG

Tablets, Oral, 15 - 45 mg (as needed for rescue)

Interventions

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Saxagliptin + Metformin

Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Intervention Type DRUG

Saxagliptin + Metformin

Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Intervention Type DRUG

Saxagliptin + Metformin

Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Intervention Type DRUG

Placebo + Metformin

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

Intervention Type DRUG

Pioglitazone

Tablets, Oral, 15 - 45 mg (as needed for rescue)

Intervention Type DRUG

Other Intervention Names

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BMS-477118 BMS-477118 BMS-477118

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
* HbA1c \>= 7.0% and \<= 10.0 %
* Body mass index \<= 40 kg/m2
* Fasting C-peptide \>= 1 ng/dL

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 females
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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Haleyville, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Sherwood, Arkansas, United States

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Encino, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Northridge, California, United States

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Orange, California, United States

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Roseville, California, United States

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Sacramento, 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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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Golden, 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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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Marianna, Florida, United States

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Miami, 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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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Vernon Hills, Illinois, United States

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Elkhart, Indiana, United States

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Lafayette, Indiana, United States

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Iowa City, Iowa, United States

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Waterloo, Iowa, United States

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Topeka, 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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Boston, Massachusetts, United States

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Kansas City, 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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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Morehead City, North Carolina, United States

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Salisbury, North Carolina, United States

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Sparta, North Carolina, United States

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Wilmington, 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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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Carlisle, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Levittown, 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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Duncan, South Carolina, United States

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Bristol, Tennessee, United States

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Austin, Texas, United States

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Bryan, Texas, United States

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Carrollton, Texas, United States

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Dallas, 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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Salt Lake City, Utah, United States

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Hampton, Virginia, United States

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Virginia Beach, Virginia, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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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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Fortaleza, Ceará, Brazil

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Belém, Pará, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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Marília, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Surrey, British Columbia, Canada

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Brandon, Manitoba, 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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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Aylmer, Ontario, Canada

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London, Ontario, Canada

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Oakville, Ontario, Canada

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Sarnia, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Woodstock, 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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Longueuil, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Santiago, Santiago Metropolitan, Chile

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Durango, Durango, Mexico

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Celaya, Guanajuato, Mexico

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Guadalajara, Jalisco, Mexico

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Distrito Federal, Mexico City, Mexico

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Morelia, Michioacan, Mexico

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Monterrey, Nuevo León, Mexico

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Hermosillo, Sonora, Mexico

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Mérida, Yucatán, Mexico

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Carolina, , Puerto Rico

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Ponce, , Puerto Rico

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Rio Pieoras, , 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 Argentina Australia Brazil Canada Chile Mexico Puerto Rico Taiwan

References

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DeFronzo RA, Hissa MN, Garber AJ, Luiz Gross J, Yuyan Duan R, Ravichandran S, Chen RS; Saxagliptin 014 Study Group. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009 Sep;32(9):1649-55. doi: 10.2337/dc08-1984. Epub 2009 May 28.

Reference Type BACKGROUND
PMID: 19478198 (View on PubMed)

Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.

Reference Type DERIVED
PMID: 31364269 (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)

Karyekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.

Reference Type DERIVED
PMID: 23795975 (View on PubMed)

Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.

Reference Type DERIVED
PMID: 21680990 (View on PubMed)

Other Identifiers

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CV181-014

Identifier Type: -

Identifier Source: org_study_id

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