A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Saxagliptin; Drug: Saxagliptin; Drug: Metformin; Drug: pioglitazone; Drug: Placebo

Detailed Description

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 pioglitazone (rescue medication) added onto their blinded study medication

• Study Type: Interventional
• Enrollment (Actual): 1306
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1121
    • Local Institution
  • Buenos Aires, Argentina, C1425AGC
    • Local Institution
  • Buenos Aires, Argentina, C1408INH
    • Local Institution
  • Buenos Aires, Argentina, B7602CBM
    • Local Institution
  • Buenos Aires, Argentina, C1117ABH
    • Local Institution
  • Buenos Aires, Argentina, C1505CWB
    • Local Institution
  • Mendoza, Argentina, CP5500
    • Local Institution
  • Salta, Argentina, 4406
    • Local Institution
  • Salta, Argentina, A4400EMI
    • Local Institution
  • San Juan, Argentina, 5400
    • Local Institution
  • Buenos Aires
    • Belgrano, Buenos Aires, Argentina, C1426EGP
      • Local Institution
    • Capital Federal, Buenos Aires, Argentina, 1221
      • Local Institution
    • Capital Federal, Buenos Aires, Argentina, C1406GWY
      • Local Institution
    • Chacabuco, Buenos Aires, Argentina, 6740
      • Local Institution
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Local Institution
    • Moron, Buenos Aires, Argentina, B1708IFF
      • Local Institution
    • San Martin, Buenos Aires, Argentina, CP1405
      • Local Institution
    • San Pedro, Buenos Aires, Argentina, B2930DGO
      • Local Institution
    • Zarate, Buenos Aires, Argentina, 2800
      • Local Institution
  • Santa Fe
    • Rosario, Santa Fe, Argentina, CP2000
      • Local Institution
  • Tucuman
    • Lanus Este, Tucuman, Argentina, 1824
      • Local Institution
• Brazil
  • Sao Paulo, Brazil, 04020
    • Local Institution
  • Sao Paulo, Brazil, 01244
    • Local Institution
  • Ceara
    • Fortaleza, Ceara, Brazil, 60021
      • Local Institution
    • Fortaleza, Ceara, Brazil, 60430
      • Local Institution
  • Goias
    • Goiania, Goias, Brazil, 74110
      • Local Institution
  • Para
    • Belem, Para, Brazil, 66073
      • Local Institution
  • Pe
    • Recife, Pe, Brazil, 52051
      • Local Institution
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
      • Local Institution
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13059
      • Local Institution
    • Marília, Sao Paulo, Brazil, 17519
      • Local Institution
• Germany
  • Aschaffenburg, Germany, 63739
    • Local Institution
  • Bad, Germany, 37431
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Dresden, Germany, O1219
    • Local Institution
  • Duisburg, Germany, 47051
    • Local Institution
  • Heidelberg, Germany, 69120
    • Local Institution
  • Kuenzing, Germany, 94550
    • Local Institution
  • Ludwigshafen, Germany, 67073
    • Local Institution
  • Magdeburg, Germany, 39112
    • Local Institution
  • Mainz, Germany, 55116
    • Local Institution
  • Mannheim, Germany, 68161
    • Local Institution
  • Saarbrücken, Germany, 66119
    • Local Institution
  • Vellmar, Germany, 34246
    • Local Institution
  • Wangen Im Allgau, Germany, 88239
    • Local Institution
• Hungary
  • Eger, Hungary, 3300
    • Local Institution
  • Gyula, Hungary, 5700
    • Local Institution
  • Szentes, Hungary, 6600
    • Local Institution
  • Szigetvár, Hungary, 7900
    • Local Institution
  • Érd, Hungary, 2030
    • Local Institution
• India
  • Bangalore, India, 560054
    • Local Institution
  • Chennai, India, 680004
    • Local Institution
  • Haryana, India, 132001
    • Local Institution
  • Rajasthan, India, 302001
    • Local Institution
  • Rajasthan, India, 334 003
    • Local Institution
  • Vellore, Tamilnadu, India, 632004
    • Local Institution
  • Andhra Pradesh
    • Panjagutta, Hyderabad, Andhra Pradesh, India, 500082
      • Local Institution
  • Bangalore
    • Vasanth Nagar, Bangalore, India, 560052
      • Local Institution
  • Karnataka
    • Bangalore, Karnataka, India, 560010
      • Local Institution
  • Maharashtra
    • Pune, Maharashtra, India, 411011
      • Local Institution
  • Mumbai
    • Kandivili West, Mumbai, India, 400067
      • Local Institution
  • New Delhi
    • Sarita Vihar, New Delhi, India, 110076
      • Local Institution
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 680086
      • Local Institution
• Italy
  • Catania, Italy, 20099
    • Local Institution
  • Genova, Italy, 16132
    • Local Institution
  • Milano, Italy, 20132
    • Local Institution
  • Perugia, Italy, 06124
    • Local Institution
  • Ravenna, Italy, 48100
    • Local Institution
• Mexico
  • Aguascalientes, Mexico, 20230
    • Local Institution
  • Aguascalientes, Mexico, 20232
    • Local Institution
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06700
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 44670
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 44340
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 45030
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 45200
      • Local Institution
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62250
      • Local Institution
  • Nuevo Leon
    • Garza Garcia, Nuevo Leon, Mexico, 66260
      • Local Institution
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Local Institution
    • Monterrey, Nuevo Leon, Mexico, 64020
      • Local Institution
    • Monterrey, Nuevo Leon, Mexico, 64570
      • Local Institution
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Local Institution
• Philippines
  • Cebu City, Philippines, 6000
    • Local Institution
  • Iloilo City, Philippines, 5000
    • Local Institution
  • Manila City, Philippines, 1000
    • Local Institution
  • Marikina City, Philippines, 1800
    • Local Institution
  • Pasig City, Philippines, 1605
    • Local Institution
  • Quezon City, Philippines, 1100
    • Local Institution
• Poland
  • Gniewkowo, Poland, 88-140
    • Local Institution
  • Gorzow Wielkopolski, Poland, 66-400
    • Local Institution
  • Izabelin, Poland, 05-080
    • Local Institution
  • Krakow, Poland, 31-159
    • Local Institution
  • Lublin, Poland, 20-538
    • Local Institution
  • Michalow-Regionow, Poland, 05-119
    • Local Institution
  • Warszawa, Poland, 03-563
    • Local Institution
  • Wroclaw, Poland, 50-127
    • Local Institution
  • Zabrze, Poland, 41-800
    • Local Institution
• Puerto Rico
  • Carolina, Puerto Rico, 00983
    • Local Institution
  • Ponce, Puerto Rico, 00716
    • Local Institution
  • Ponce, Puerto Rico, 00717
    • Local Institution
  • Rio Pieoras, Puerto Rico, 00926
    • Local Institution
  • San Juan, Puerto Rico, 00909
    • Local Institution
  • San Juan, Puerto Rico, 00920
    • Local Institution
• Russian Federation
  • Izhevsk, Russian Federation, 426000
    • Local Institution
  • Kirov, Russian Federation, 610030
    • Local Institution
  • Krasnodar, Russian Federation, 350012
    • Local Institution
  • Krasnodar, Russian Federation, 350042
    • Local Institution
  • Kursk, Russian Federation, 305035
    • Local Institution
  • Moscow, Russian Federation, 129327
    • Local Institution
  • Moscow, Russian Federation, 105229
    • Local Institution
  • Moscow, Russian Federation, 119034
    • Local Institution
  • Moscow, Russian Federation, 115093
    • Local Institution
  • Moscow, Russian Federation, 115280
    • Local Institution
  • Moscow, Russian Federation, 117292
    • Local Institution
  • Moscow, Russian Federation, 11992
    • Local Institution
  • Moscow, Russian Federation, 123423
    • Local Institution
  • Moscow, Russian Federation, 125315
    • Local Institution
  • Moscow, Russian Federation, 127486
    • Local Institution
  • Moscow, Russian Federation, 127644
    • Local Institution
  • Moscow, Russian Federation, 129010
    • Local Institution
  • Moscow, Russian Federation, 129119
    • Local Institution
  • Nizhniy Novgorod, Russian Federation, 603126
    • Local Institution
  • Novosibirsk, Russian Federation, 630047
    • Local Institution
  • Novosibirsk, Russian Federation, 630087
    • Local Institution
  • Perm, Russian Federation, 614095
    • Local Institution
  • Rostov-Na-Donu, Russian Federation, 344022
    • Local Institution
  • Rostov-Na-Donu, Russian Federation, 344029
    • Local Institution
  • Saint Petersburg, Russian Federation, 198013
    • Local Institution
  • Saratov, Russian Federation, 410028
    • Local Institution
  • Saratov, Russian Federation, 410054
    • Local Institution
  • Saratov, Russian Federation, 410024
    • Local Institution
  • Saratov, Russian Federation, 410053
    • Local Institution
  • Smolensk, Russian Federation, 214018
    • Local Institution
  • St Petersburg, Russian Federation, 193015
    • Local Institution
  • St-Petersburg, Russian Federation, 197022
    • Local Institution
  • St. Peterburg, Russian Federation, 195257
    • Local Institution
  • St. Petersburg, Russian Federation, 195112
    • Local Institution
  • St. Petersburg, Russian Federation, 193312
    • Local Institution
  • St. Petersburg, Russian Federation, 197198
    • Local Institution
  • St.Petersburg, Russian Federation, 191119
    • Local Institution
  • St.Petersburg, Russian Federation, 192177
    • Local Institution
  • St.Petersburg, Russian Federation, 194354
    • Local Institution
  • St.Petersburg, Russian Federation, 195176
    • Local Institution
  • Tuymen, Russian Federation, 625023
    • Local Institution
  • Vladimir, Russian Federation, 600023
    • Local Institution
  • Volgograd, Russian Federation, 400001
    • Local Institution
  • Volgograd, Russian Federation, 400107
    • Local Institution
  • Yaroslaval, Russian Federation, 150003
    • Local Institution
  • Yaroslavl, Russian Federation, 150003
    • Local Institution
  • Russia
    • Kemerovo, Russia, Russian Federation, 650066
      • Local Institution
    • Moscow, Russia, Russian Federation, 117593
      • Local Institution
    • Moscow, Russia, Russian Federation, 123056
      • Local Institution
    • Moscow, Russia, Russian Federation, 125299
      • Local Institution
    • Nizhniy Novgorod, Russia, Russian Federation, 603018
      • Local Institution
• Ukraine
  • Dniepropetrovsk, Ukraine, 49044
    • Local Institution
  • Kharkiv, Ukraine, 61176
    • Local Institution
  • Kharkiv, Ukraine, 61039
    • Local Institution
  • Kyiv, Ukraine, 03680
    • Local Institution
  • Kyiv, Ukraine, 4050
    • Local Institution
  • Lutsk, Ukraine, 43024
    • Local Institution
  • Lviv, Ukraine, 790015
    • Local Institution
  • Lviv, Ukraine, 79013
    • Local Institution
  • Odessa, Ukraine, 65025
    • Local Institution
  • Ternopil, Ukraine, 46001
    • Local Institution
• United States
  • California
    • Concord, California, United States, 94520
      • East Bay Clinical Trial Center
    • Encinitas, California, United States, 92024
      • Encompass Clinical Research
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • Santa Monica, California, United States, 90404
      • Coastal Biomedical Research Inc
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Stockton, California, United States, 95204
      • St. Joseph's Medical Associates
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Therapeutics Corporation
    • Gainesville, Florida, United States, 32605
      • Florida Research Network, LLC
    • Kissimmee, Florida, United States, 34741
      • FPA Clinical Research
    • Marianna, Florida, United States, 32446
      • Emerald Coast Research Group
    • Miami, Florida, United States, 33156
      • Baptist Diabetes Associates
  • Georgia
    • Perry, Georgia, United States, 31069
      • Middle Georgia Drug Study Center, Llc
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
    • Chicago, Illinois, United States, 60617
      • Adviso Medical Research, Llc
    • Vernon Hills, Illinois, United States, 60061
      • Deerbrook Medical Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Physicians Research Group
  • Kansas
    • Wichita, Kansas, United States, 67203
      • Professional Network Research Of Kansas
  • Missouri
    • Excelsior Springs, Missouri, United States, 64024
      • Medical Arts Research Collaborative, Llc
  • Nevada
    • N. Las Vegas, Nevada, United States, 89030
      • Nevada Alliance Against Diabetes
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Metrolina Medical Research
    • Durham, North Carolina, United States, 27704
      • Durham Internal Medicine Assoc.
    • Morehead City, North Carolina, United States, 28557
      • Down East Medical Associates
  • Ohio
    • Bellbrook, Ohio, United States, 45305
      • Midwest Regional Research, Inc.
    • Massillon, Ohio, United States, 44646
      • Massillon Family Practice
    • Mentor, Ohio, United States, 44060
      • Your Diabetes Endocrine Nutrition Group
    • Newark, Ohio, United States, 43055
      • Newark Physician Associates
  • Pennsylvania
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • Rhode Island
    • E. Providence, Rhode Island, United States, 02914
      • Safe Harbor Clinical Research
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Internal Medicine Of Greer
  • Tennessee
    • Fayetteville, Tennessee, United States, 37334
      • Middle Tennessee Clinical Research
    • Memphis, Tennessee, United States, 38103
      • Frontier Clinical Research, Llc.
  • Texas
    • Austin, Texas, United States, 78705
      • Capital Medical Clinic, Llp
    • Houston, Texas, United States, 77036
      • Juno Research, LLC
    • Houston, Texas, United States, 77004
      • Endocrine Associates
    • Houston, Texas, United States, 77030
      • Advances In Health,Inc
    • Houston, Texas, United States, 77074
      • Non Invasive Cardiovascular Pa
    • Irving, Texas, United States, 75039
      • Tiena Health Research
    • Midland, Texas, United States, 79705
      • Diabetes Center of the Southwest
    • New Braunfels, Texas, United States, 78130
      • Hill Country Medical Associates
    • Pearland, Texas, United States, 77584
      • Pearland Primary Care Associates, Llp
    • Rosenberg, Texas, United States, 77471
      • Med-Cure Primary Care Physicians
    • San Antonio, Texas, United States, 78229
      • S.A.M. Clinical Research Center
    • San Antonio, Texas, United States, 78213
      • Gsa Research
    • San Antonio, Texas, United States, 78229
      • Covenant Clinical Research, Pa
  • Virginia
    • Falls Church, Virginia, United States, 22044
      • Seven Corners Medical Research Center
    • Salem, Virginia, United States, 24153
      • Salem Va Medical Ctr Research & Devlopment
  • Washington
    • Spokane, Washington, United States, 99204
      • Physicians Clinic Of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 2 diabetes
• Inadequate blood sugar control
• No current treatment with other medications to lower blood sugar

Exclusion Criteria:

• Major heart, liver or kidney problems
• Pregnant or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Saxagliptin and Metformin (A); PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin; Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT); Other Names: BMS-477118; Drug: Saxagliptin; Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT); Other Names: BMS-477118; Drug: Metformin; Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT); Drug: pioglitazone; Tablets, Oral, 15-45 mg, as needed (12 months LT)
Experimental: Saxagliptin and Metformin (B); PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin; Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT); Other Names: BMS-477118; Drug: Saxagliptin; Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT); Other Names: BMS-477118; Drug: Metformin; Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT); Drug: pioglitazone; Tablets, Oral, 15-45 mg, as needed (12 months LT)
Experimental: Saxagliptin and Placebo (C); PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin; Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT); Other Names: BMS-477118; Drug: Saxagliptin; Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT); Other Names: BMS-477118; Drug: pioglitazone; Tablets, Oral, 15-45 mg, as needed (12 months LT); Drug: Placebo; Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
Active Comparator: Metformin and Placebo (D); PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Metformin; Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT); Drug: pioglitazone; Tablets, Oral, 15-45 mg, as needed (12 months LT); Drug: Placebo; Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Mean change from baseline in A1C at Week 24, adjusted for baseline value.	Baseline, Week 24
Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Mean change from baseline in A1C at Week 24, adjusted for baseline value.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Mean change from baseline in FPG at Week 24, adjusted for baseline value.	Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Mean change from baseline in FPG at Week 24, adjusted for baseline value.	Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.	Week 24
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.	Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.	Baseline, Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.	Baseline, Week 24
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.	Week 24
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.	Week 24
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.	Week 24
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.	Week 24

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
• Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
• Jadzinsky M, Pfutzner A, Paz-Pacheco E, Xu Z, Allen E, Chen R; CV181-039 Investigators. Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes Metab. 2009 Jun;11(6):611-22. doi: 10.1111/j.1463-1326.2009.01056.x.
• 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.
• Pfutzner A, Paz-Pacheco E, Allen E, Frederich R, Chen R; CV181039 Investigators. Initial combination therapy with saxagliptin and metformin provides sustained glycaemic control and is well tolerated for up to 76 weeks. Diabetes Obes Metab. 2011 Jun;13(6):567-76. doi: 10.1111/j.1463-1326.2011.01385.x.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 15, 2006
• First Submitted That Met QC Criteria: May 15, 2006
• First Posted (Estimate): May 17, 2006

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Pioglitazone; Saxagliptin
• Other Study ID Numbers: CV181-039