DiabetesPhase 3NCT00327015

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 Phase 3 study testing Saxagliptin, Metformin and pioglitazone in people with Diabetes, run by AstraZeneca at 211 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 77 years
Conditions the study is for: Diabetes
What is being tested?: Saxagliptin, Metformin and pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,306 participants
Where: 211 sitesin 13 countries
Study dates: May 2006to Dec 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 77 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Major heart, liver or kidney problems
Pregnant or breast feeding

Trial locations and contacts

211 sites in 13 countries.

Country

City, postcode or hospital

211 sites in 13 countries

Russia51 sites

Local Institution
Izhevsk, 426000
Local Institution
Kemerovo, Russia, 650066
Local Institution
Kirov, 610030
Local Institution
Krasnodar, 350012
Local Institution
Krasnodar, 350042
Local Institution
Kursk, 305035
Local Institution
Moscow, Russia, 117593
Local Institution
Moscow, Russia, 123056
Local Institution
Moscow, Russia, 125299
Local Institution
Moscow, 105229
Local Institution
Moscow, 115093
Local Institution
Moscow, 115280
Local Institution
Moscow, 117292
Local Institution
Moscow, 119034
Local Institution
Moscow, 11992
Local Institution
Moscow, 123423
Local Institution
Moscow, 125315
Local Institution
Moscow, 127486
Local Institution
Moscow, 127644
Local Institution
Moscow, 129010
Local Institution
Moscow, 129119
Local Institution
Moscow, 129327
Local Institution
Nizhny Novgorod, Russia, 603018
Local Institution
Nizhny Novgorod, 603126
Local Institution
Novosibirsk, 630047
Local Institution
Novosibirsk, 630087
Local Institution
Perm, 614095
Local Institution
Rostov-on-Don, 344022
Local Institution
Rostov-on-Don, 344029
Local Institution
Saint Peterburg, 195257
Local Institution
Saint Petersburg, 191119
Local Institution
Saint Petersburg, 192177
Local Institution
Saint Petersburg, 193015
Local Institution
Saint Petersburg, 193312
Local Institution
Saint Petersburg, 194354
Local Institution
Saint Petersburg, 195112
Local Institution
Saint Petersburg, 195176
Local Institution
Saint Petersburg, 197022
Local Institution
Saint Petersburg, 197198
Local Institution
Saint Petersburg, 198013
Local Institution
Saratov, 410024
Local Institution
Saratov, 410028
Local Institution
Saratov, 410053
Local Institution
Saratov, 410054
Local Institution
Smolensk, 214018
Local Institution
Tuymen, 625023
Local Institution
Vladimir, 600023
Local Institution
Volgograd, 400001
Local Institution
Volgograd, 400107
Local Institution
Yaroslaval, 150003
Local Institution
Yaroslavl, 150003

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United States47 sites

Capital Medical Clinic, Llp
Austin, Texas, 78705
Midwest Regional Research, Inc.
Bellbrook, Ohio, 45305
Metrolina Medical Research
Charlotte, North Carolina, 28209
Cedar Crosse Research Center
Chicago, Illinois, 60607
Adviso Medical Research, Llc
Chicago, Illinois, 60617
East Bay Clinical Trial Center
Concord, California, 94520
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134
Durham Internal Medicine Assoc.
Durham, North Carolina, 27704
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914
Encompass Clinical Research
Encinitas, California, 92024
Medical Arts Research Collaborative, Llc
Excelsior Springs, Missouri, 64024
Seven Corners Medical Research Center
Falls Church, Virginia, 22044
Middle Tennessee Clinical Research
Fayetteville, Tennessee, 37334
Florida Research Network, Llc
Gainesville, Florida, 32605
Internal Medicine Of Greer
Greer, South Carolina, 29651
Endocrine Associates
Houston, Texas, 77004
Advances In Health,Inc
Houston, Texas, 77030
Juno Research, Llc
Houston, Texas, 77036
Non Invasive Cardiovascular Pa
Houston, Texas, 77074
Physicians Research Group
Indianapolis, Indiana, 46250
Tiena Health Research
Irving, Texas, 75039
Fpa Clinical Research
Kissimmee, Florida, 34741
Emerald Coast Research Group
Marianna, Florida, 32446
Massillon Family Practice
Massillon, Ohio, 44646
Frontier Clinical Research, Llc.
Memphis, Tennessee, 38103
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, 44060
Baptist Diabetes Associates
Miami, Florida, 33156
Diabetes Center Of The Southwest
Midland, Texas, 79705
Down East Medical Associates
Morehead City, North Carolina, 28557
Hill Country Medical Associates
New Braunfels, Texas, 78130
Newark Physician Associates
Newark, Ohio, 43055
Nevada Alliance Against Diabetes
North Las Vegas, Nevada, 89030
Community Clinical Trials
Orange, California, 92868
Pearland Primary Care Associates, Llp
Pearland, Texas, 77584
Middle Georgia Drug Study Center, Llc
Perry, Georgia, 31069
Med-Cure Primary Care Physicians
Rosenberg, Texas, 77471
Salem Va Medical Ctr Research & Devlopment
Salem, Virginia, 24153
Gsa Research
San Antonio, Texas, 78213
Covenant Clinical Research, Pa
San Antonio, Texas, 78229
S.A.M. Clinical Research Center
San Antonio, Texas, 78229
Coastal Biomedical Research Inc
Santa Monica, California, 90404
Physicians Clinic Of Spokane
Spokane, Washington, 99204
Encompass Clinical Research
Spring Valley, California, 91978
St. Joseph'S Medical Associates
Stockton, California, 95204
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061
Professional Network Research Of Kansas
Wichita, Kansas, 67203

Other trials in United States

Argentina21 sites

Local Institution
Belgrano, Buenos Aires, C1426EGP
Local Institution
Buenos Aires, Buenos Aires, 1121
Local Institution
Buenos Aires, Buenos Aires, B7602CBM
Local Institution
Buenos Aires, Buenos Aires, C1117ABH
Local Institution
Buenos Aires, Buenos Aires, C1425AGC
Local Institution
Buenos Aires, C1408INH
Local Institution
Buenos Aires, C1505CWB
Local Institution
Capital Federal, Buenos Aires, 1221
Local Institution
Capital Federal, Buenos Aires, C1406GWY
Local Institution
Chacabuco, Buenos Aires, 6740
Local Institution
La Plata, Buenos Aires, B1902COS
Local Institution
Lanus Este, Tucumán Province, 1824
Local Institution
Mendoza, Mendoza Province, CP5500
Local Institution
Morón, Buenos Aires, B1708IFF
Local Institution
Rosario, Santa Fe Province, CP2000
Local Institution
Salta, Salta Province, 4406
Local Institution
Salta, Salta Province, A4400EMI
Local Institution
San Juan, San Juan Province, 5400
Local Institution
San Martín, Buenos Aires, CP1405
Local Institution
San Pedro, Buenos Aires, B2930DGO
Local Institution
Zárate, Buenos Aires, 2800

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Germany14 sites

Local Institution
Aschaffenburg, 63739
Local Institution
Bad, 37431
Local Institution
Dresden, 01307
Local Institution
Dresden, O1219
Local Institution
Duisburg, 47051
Local Institution
Heidelberg, 69120
Local Institution
Künzing, 94550
Local Institution
Ludwigshafen, 67073
Local Institution
Magdeburg, 39112
Local Institution
Mainz, 55116
Local Institution
Mannheim, 68161
Local Institution
Saarbrücken, 66119
Local Institution
Vellmar, 34246
Local Institution
Wangen, 88239

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Mexico14 sites

Local Institution
Aguascalientes, Aguascalientes, 20230
Local Institution
Aguascalientes, Aguascalientes, 20232
Local Institution
Cuernavaca, Morelos, 62250
Local Institution
Garza García, Nuevo León, 66260
Local Institution
Guadalajara, Jalisco, 44340
Local Institution
Guadalajara, Jalisco, 44650
Local Institution
Guadalajara, Jalisco, 44670
Local Institution
Guadalajara, Jalisco, 45030
Local Institution
Guadalajara, Jalisco, 45200
Local Institution
Mérida, Yucatán, 97070
Local Institution
Mexico City, Mexico City, 06700
Local Institution
Monterrey, Nuevo León, 64020
Local Institution
Monterrey, Nuevo León, 64460
Local Institution
Monterrey, Nuevo León, 64570

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India13 sites

Local Institution
Bangalore, Karnataka, 560010
Local Institution
Bangalore, 560054
Local Institution
Chennai, Tamil Nadu, 680086
Local Institution
Chennai, 680004
Local Institution
Haryāna, 132001
Local Institution
Kandivili West, Mumbai, 400067
Local Institution
Panjagutta, Hyderabad, Andhra Pradesh, 500082
Local Institution
Pune, Maharashtra, 411011
Local Institution
Rajasthan, 302001
Local Institution
Rajasthan, 334 003
Local Institution
Sarita Vihar, New Delhi, 110076
Local Institution
Vasanth Nagar, Bangalore, 560052
Local Institution
Vellore, Tamilnadu, 632004

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Brazil10 sites

Local Institution
Belém, Pará, 66073
Local Institution
Campinas, São Paulo, 13059
Local Institution
Fortaleza, Ceará, 60021
Local Institution
Fortaleza, Ceará, 60430
Local Institution
Goiânia, Goiás, 74110
Local Institution
Marília, São Paulo, 17519
Local Institution
Porto Alegre, Rio Grande do Sul, 90035
Local Institution
Recife, Pernambuco, 52051
Local Institution
São Paulo, São Paulo, 01244
Local Institution
São Paulo, São Paulo, 04020

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Ukraine10 sites

Local Institution
Dniepropetrovsk, 49044
Local Institution
Kharkiv, 61039
Local Institution
Kharkiv, 61176
Local Institution
Kyiv, 03680
Local Institution
Kyiv, 4050
Local Institution
Lutsk, 43024
Local Institution
Lviv, 790015
Local Institution
Lviv, 79013
Local Institution
Odesa, 65025
Local Institution
Ternopil, 46001

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Poland9 sites

Local Institution
Gniewkowo, 88-140
Local Institution
Gorzów Wielkopolski, 66-400
Local Institution
Izabelin, 05-080
Local Institution
Krakow, 31-159
Local Institution
Lublin, 20-538
Local Institution
Michalow-Regionow, 05-119
Local Institution
Warsaw, 03-563
Local Institution
Wroclaw, 50-127
Local Institution
Zabrze, 41-800

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Philippines6 sites

Local Institution
Cebu City, 6000
Local Institution
Iloilo City, 5000
Local Institution
Manila, 1000
Local Institution
Marikina City, 1800
Local Institution
Pasig, 1605
Local Institution
Quezon City, 1100

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Puerto Rico6 sites

Local Institution
Carolina, 00983
Local Institution
Ponce, 00716
Local Institution
Ponce, 00717
Local Institution
Rio Pieoras, 00926
Local Institution
San Juan, 00909
Local Institution
San Juan, 00920

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Hungary5 sites

Local Institution
Eger, 3300
Local Institution
Érd, 2030
Local Institution
Gyula, 5700
Local Institution
Szentes, 6600
Local Institution
Szigetvár, 7900

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Italy5 sites

Local Institution
Catania, 20099
Local Institution
Genova, 16132
Local Institution
Milan, 20132
Local Institution
Perugia, 06124
Local Institution
Ravenna, 48100

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About this study

Official title: 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

Read the 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

Conditions: Diabetes
Being tested: Saxagliptin, Metformin, Placebo, pioglitazone
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SaxagliptinDrug
Also called BMS-477118
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
SaxagliptinDrug
Also called BMS-477118
Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
MetforminDrug
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
PlaceboDrug
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
pioglitazoneDrug
Tablets, Oral, 15-45 mg, as needed (12 months LT)

Study groups in NCT00327015
Study group	Role	What they receive
Saxagliptin and Metformin (A)	Experimental	PLUS open-label pioglitazone (as needed as rescue medication) Receives: Drug: Saxagliptin; Drug: Metformin; Drug: pioglitazone
Saxagliptin and Metformin (B)	Experimental	PLUS open-label pioglitazone (as needed as rescue medication) Receives: Drug: Saxagliptin; Drug: Metformin; Drug: pioglitazone
Saxagliptin and Placebo (C)	Experimental	PLUS open-label pioglitazone (as needed as rescue medication) Receives: Drug: Saxagliptin; Drug: Placebo; Drug: pioglitazone
Metformin and Placebo (D)	Active comparator	PLUS open-label pioglitazone (as needed as rescue medication) Receives: Drug: Metformin; Drug: Placebo; Drug: pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline, Week 24

Secondary outcomes (10)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Dec 2008

First posted17 May 2006 (estimated)
Study startMay 2006
Primary completionNov 2007
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00327015
Sponsor's protocol ID: CV181-039
Status last verified: Mar 2015
First submitted: 15 May 2006
Last updated: 29 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 19515181
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.
PubMed 32501595
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.
PubMed 25414932
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.
PubMed 23795975
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.
PubMed 21342412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00327015
Acronym / sponsor ID: CV181-039
Conditions: Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,306 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Nov 2007 (actual)
Study completion: Dec 2008 (actual)
First posted: 17 May 2006 (estimated)
Results: Posted 25 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Saxagliptin and Metformin (A)	Experimental	Drug: Saxagliptin, Drug: Metformin, Drug: pioglitazonePLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Metformin (B)	Experimental	Drug: Saxagliptin, Drug: Metformin, Drug: pioglitazonePLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Placebo (C)	Experimental	Drug: Saxagliptin, Drug: Placebo, Drug: pioglitazonePLUS open-label pioglitazone (as needed as rescue medication)
Metformin and Placebo (D)	Active comparator	Drug: Metformin, Drug: Placebo, Drug: pioglitazonePLUS open-label pioglitazone (as needed as rescue medication)

Who may qualify

Ages: 18 to 77 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Major heart, liver or kidney problems
Pregnant or breast feeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SaxagliptinAlso: BMS-477118Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)	Drug	Saxagliptin and Metformin (A), Saxagliptin and Placebo (C)
SaxagliptinAlso: BMS-477118Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)	Drug	Saxagliptin and Metformin (B)
MetforminCoated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)	Drug	Metformin and Placebo (D), Saxagliptin and Metformin (A), Saxagliptin and Metformin (B)
PlaceboCoated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)	Drug	Metformin and Placebo (D), Saxagliptin and Placebo (C)
pioglitazoneTablets, Oral, 15-45 mg, as needed (12 months LT)	Drug	Metformin and Placebo (D), Saxagliptin and Metformin (A), Saxagliptin and Metformin (B), Saxagliptin and Placebo (C)

Primary outcome

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

10 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Time frame: Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Time frame: Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Time frame: Week 24
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 24
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Time frame: Week 24
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Time frame: Week 24
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Time frame: Week 24
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Time frame: Week 24

Results and safety

Results posted to the registry on 25 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saxagliptin 5 mg + Metformin	320	229
Saxagliptin 10 mg + Metformin	323	231
Saxagliptin 10 mg	335	209
Metformin	328	219

Primary outcome: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Time frame: Baseline, Week 24. Mean (Standard Error). Unit: percent

Measure	Saxagliptin 5 mg + Metformin n = 306	Saxagliptin 10 mg + Metformin n = 315	Saxagliptin 10 mg n = 317
Baseline Mean	9.41 (0.072)	9.53 (0.069)	9.61 (0.075)
Week 24 Mean	6.93 (0.066)	7.02 (0.067)	7.86 (0.085)
Adjusted Mean Change from Baseline	-2.53 (0.070)	-2.49 (0.069)	-1.69 (0.069)

Population analysed: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Primary outcome: Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Time frame: Baseline, Week 24. Mean (Standard Error). Unit: percent

Measure	Saxagliptin 5 mg + Metformin n = 306	Saxagliptin 10 mg + Metformin n = 315	Metformin n = 313
Baseline Mean	9.41 (0.072)	9.53 (0.069)	9.43 (0.073)
Week 24 Mean	6.93 (0.066)	7.02 (0.067)	7.48 (0.084)
Adjusted Mean Change from Baseline	-2.53 (0.070)	-2.49 (0.069)	-1.99 (0.069)

Population analysed: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin	15 of 328 (4.6%)	106 of 328 (32.3%)	Not reported
Saxagliptin 10 mg	16 of 335 (4.8%)	106 of 335 (31.6%)	Not reported
Saxagliptin 10 mg + Metformin	22 of 323 (6.8%)	122 of 323 (37.8%)	Not reported
Saxagliptin 5 mg + Metformin	16 of 320 (5%)	116 of 320 (36.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19515181Jadzinsky 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.
Derived from this study: PubMed 32501595Gnesin 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.
Derived from this study: PubMed 25414932Cook 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.
Derived from this study: PubMed 23795975Karyekar 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.
Derived from this study: PubMed 21342412Pfutzner 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

211 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin, Metformin and pioglitazone in people with Diabetes, run by AstraZeneca at 211 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in Russia, United States, Argentina, Germany, Mexico and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00327015, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.