DiabetesPhase 3NCT00316082

Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Phase 3 study testing Saxagliptin and metformin in people with Diabetes, run by AstraZeneca at 74 sites in 4 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 saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise 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 and metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 365 participants
Where: 74 sitesin 4 countries
Study dates: Jun 2006to Nov 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

Who cannot join

Previous treatment for diabetes
Current treatment with other medications to lower blood sugar
Major heart, liver or kidney problems
Women who are pregnant or breastfeeding

Trial locations and contacts

74 sites in 4 countries.

Country

City, postcode or hospital

74 sites in 4 countries

United States51 sites

Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32714
Strategos Medical Group
Bakersfield, California, 93311
Community Health Care, Inc.
Barberton, Ohio, 44203
Versoza & Ungab Internal Medicine Associates
Bartlett, Tennessee, 38134
Taylor/Wade Medical
Bountiful, Utah, 84010
Providence Clinical Research
Burbank, California, 91505
Clinical Research Limited
Canton, Ohio, 44718
Cumberland Valley Endocrinology Center, Llc
Carlisle, Pennsylvania, 17015
Precision Family Medicine
Carrollton, Texas, 75010
Neem Research Group Of Charlotte
Charlotte, North Carolina, 28262
Collierville Medical Specialist
Collierville, Tennessee, 38017
Tomac, Inc.
Columbiana, Alabama, 35051
Alpha Therapy Research Center
Corpus Christi, Texas, 78411
Rx For Life, Inc
Cudahy, California, 90201
Middle Tyger Family Medicine
Duncan, South Carolina, 29334
Medical Group Of Encino
Encino, California, 91436
The Office Of Patricia Buchanan
Eugene, Oregon, 97404
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708
Valley Research
Fresno, California, 93720
Diabetes Center- East Carolina University
Greenville, North Carolina, 27834
Winston Technology, Inc.
Haleyville, Alabama, 35565
Village Family Practice
Houston, Texas, 77024
Texas Center For Drug Development, P.A.
Houston, Texas, 77081
Kansas City University Of Medicine And Biosciences
Kansas City, Missouri, 64106
Wells Institute For Health Awareness
Kettering, Ohio, 45429
Holston Medical Group
Kingsport, Tennessee, 37660
Hudson Valley Clinical Research Center
Kingston, New York, 12401
Accelovance
Melbourne, Florida, 32935
Med-South Research
Memphis, Tennessee, 38116
Southwind Medical Specialist
Memphis, Tennessee, 38125
Clinical Reseacrh Advantage/ Brown Family Medicine
Mesa, Arizona, 85213
Diabetes Medical Center Of California
Northridge, California, 91325
Accelovance
Oklahoma City, Oklahoma, 73112
Integris Family Care South
Oklahoma City, Oklahoma, 73170
Pinnacle Medical Research
Overland Park, Kansas, 66215
Clinical Research Source, Inc
Perrysburg, Ohio, 43551
In Private Prictice Clinic
Pico Rivera, California, 90660
Banksville Medical, Pc
Pittsburgh, Pennsylvania, 15216
Crescent Medical Research
Salisbury, North Carolina, 28144
Optimum Clinical Research
Salt Lake City, Utah, 84102
Abbott Clinical Research Group, Inc
San Antonio, Texas, 78224
San Jose Clinical Research, Inc.
San Jose, California, 95128
University Family Healthcare, Pa
Sarasota, Florida, 34243
Biomedical Research Associates, Llc
Shippensburg, Pennsylvania, 17257
Spokane Internal Medicine
Spokane, Washington, 99216
Premier Healthcare
St. Petersburg, Florida, 33707
Southeastern Research Assoc
Taylors, South Carolina, 29687
Physicians Research Center
Toms River, New Jersey, 08755
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23451
Primary Care Physicians, Pc
Wentzville, Missouri, 63385

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About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

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 metformin (rescue medication) added onto their blinded study medication

Conditions: Diabetes
Being tested: Saxagliptin, Placebo, metformin
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, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
SaxagliptinDrug
Also called BMS-477118
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
SaxagliptinDrug
Also called BMS-477118
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
SaxagliptinDrug
Also called BMS-477118
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
PlaceboDrug
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
metforminDrug
Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Study groups in NCT00316082
Study group	Role	What they receive
Saxagliptin 2.5 mg QAM (A)	Experimental	PLUS open-label metformin (as needed as rescue medication) Receives: Drug: Saxagliptin; Drug: metformin
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)	Experimental	PLUS open-label metformin (as needed as rescue medication) Receives: Drug: Saxagliptin; Drug: metformin
Saxagliptin 5 mg QAM (C)	Experimental	PLUS open-label metformin (as needed as rescue medication) Receives: Drug: Saxagliptin; Drug: metformin
Saxagliptin 5 mg QPM (D)	Experimental	PLUS open-label metformin (as needed as rescue medication) Receives: Drug: Saxagliptin; Drug: metformin
Placebo (E)	Placebo comparator	PLUS open-label metformin (as needed as rescue medication) Receives: Drug: Placebo; Drug: metformin

What is being measured

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

Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Measured: Baseline, Week 24

Secondary outcomes (4)

Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Measured: Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
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
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo 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
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Measured: Baseline, Week 24

Timeline

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

Jun 2006Nov 2008

First posted20 Apr 2006 (estimated)
Study startJun 2006
Primary completionNov 2007
Study completionNov 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 (3)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: 365 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00316082
Sponsor's protocol ID: CV181-038
Status last verified: Mar 2015
First submitted: 18 Apr 2006
Last updated: 29 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 27402391
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.
PubMed 27033025
Frederich R, McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.
PubMed 22828124

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?

See locations

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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, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
ClinicalTrials.gov ID: NCT00316082
Acronym / sponsor ID: CV181-038
Conditions: Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 365 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2008 (actual)
First posted: 20 Apr 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 saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Saxagliptin 2.5 mg QAM (A)	Experimental	Drug: Saxagliptin, Drug: metforminPLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)	Experimental	Drug: Saxagliptin, Drug: metforminPLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QAM (C)	Experimental	Drug: Saxagliptin, Drug: metforminPLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QPM (D)	Experimental	Drug: Saxagliptin, Drug: metforminPLUS open-label metformin (as needed as rescue medication)
Placebo (E)	Placebo comparator	Drug: Placebo, Drug: metforminPLUS open-label metformin (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 (2 listed)

Type 2 diabetes
Inadequate blood sugar control

Key exclusion criteria (4 listed)

Previous treatment for diabetes
Current treatment with other medications to lower blood sugar
Major heart, liver or kidney problems
Women who are pregnant or breastfeeding

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, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)	Drug	Saxagliptin 2.5 mg QAM (A)
SaxagliptinAlso: BMS-477118Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)	Drug	Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
SaxagliptinAlso: BMS-477118Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)	Drug	Saxagliptin 5 mg QAM (C)
SaxagliptinAlso: BMS-477118Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)	Drug	Saxagliptin 5 mg QPM (D)
PlaceboCoated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)	Drug	Placebo (E)
metforminTablets, Oral, 500-2000 mg, as needed (12 months LT)	Drug	Placebo (E), Saxagliptin 2.5 mg QAM (A), Saxagliptin 2.5 mg titrated to 5 mg QAM (B), Saxagliptin 5 mg QAM (C), Saxagliptin 5 mg QPM (D)

Primary outcome

Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Time frame: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.

4 secondary outcomes

Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Time frame: Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24
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
Time frame: Baseline, 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 2.5 mg Once in the Morning (QAM)	74	41
Saxagliptin 5 mg QAM	74	52
Saxagliptin 2.5/5 mg QAM	71	44
Saxagliptin 5 mg Once in the Evening (QPM)	72	46
Placebo	74	48

Primary outcome: Change From Baseline in Hemoglobin A1 (A1C) at Week 24

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

Measure	Saxagliptin 2.5 mg QAM n = 67	Saxagliptin 5 mg QAM n = 69	Saxagliptin 2.5/5 mg QAM n = 69	Placebo n = 68
Baseline Mean	8.04 (0.105)	7.93 (0.106)	8.02 (0.131)	7.79 (0.112)
Week 24 Mean	7.30 (0.106)	7.27 (0.129)	7.37 (0.137)	7.57 (0.141)
Adjusted Mean Change from Baseline	-0.71 (0.103)	-0.66 (0.102)	-0.63 (0.102)	-0.26 (0.103)

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), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.

4 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
Placebo	5 of 74 (6.8%)	22 of 74 (29.7%)	Not reported
Saxagliptin 2.5/5 mg QAM	7 of 71 (9.9%)	30 of 71 (42.3%)	Not reported
Saxagliptin 2.5 mg QAM	7 of 74 (9.5%)	32 of 74 (43.2%)	Not reported
Saxagliptin 5 mg QAM	8 of 74 (10.8%)	33 of 74 (44.6%)	Not reported
Saxagliptin 5 mg QPM	4 of 72 (5.6%)	29 of 72 (40.3%)	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.
Derived from this study: PubMed 27402391Perl 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.
Derived from this study: PubMed 27033025Bonora 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.
Derived from this study: PubMed 22828124Frederich R, McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.

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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

74 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin and metformin in people with Diabetes, run by AstraZeneca at 74 sites in 4 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 2 inclusion and 4 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 74 sites in United States, Russia, India, Taiwan. 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. Some participants in this study may receive a placebo. 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 A1 (A1C) at Week 24 (time frame: Baseline, Week 24). 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 NCT00316082, which also lists 3 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.