Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

A Phase 3 study testing Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 27 sites in 8 countries.

Completed

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

Trial summary

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone Read more about this study

Who is it for?: Ages 18 to 77 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Saxagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 93 participants
Where: 27 sitesin 8 countries
Study dates: Jul 2008to Feb 2009
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

≥18- and ≤77-years-old
Type 2 diabetes
Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
Glycosylated hemoglobin (A1C) ≥7% and ≤10%
Body mass index (BMI) ≤40 kg/m2

Who cannot join

Women of childbearing potential unable or unwilling to use acceptable birth control
Women who are pregnant or breastfeeding
Significant cardiovascular history
Active liver disease
Renal impairment

Trial locations and contacts

27 sites in 8 countries.

Country

City, postcode or hospital

27 sites in 8 countries

United States13 sites

River Birch Research Alliance, Llc
Blue Ridge, Georgia, 30513
Amcr Institute, Inc
Escondido, California, 92026
Irvine Center For Clinical Research, Inc.
Irvine, California, 92618
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007
Avastra Clinical Trials
Midvale, Utah, 84047
Clinilabs, Inc.
New York, New York, 10019
Dedicated Phase I, Inc.
Phoenix, Arizona, 85013
Covance Cru, Inc.
Portland, Oregon, 97239
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, 92373
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Dgd Research, Inc.
San Antonio, Texas, 78229
Advantage Clinical Research
Santa Ana, California, 92701
Orange County Research Center
Tustin, California, 92780

Other trials in United States

Israel4 sites

Local Institution
Holon, 58100
Local Institution
Jerusalem, 91120
Local Institution
Kfar Saba, 44281
Local Institution
Tsrifin, 70300

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Sweden3 sites

Local Institution
Gothenburg, 413 45
Local Institution
Huddinge, 141 86
Local Institution
Lund, Sweden, 221 85

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Mexico2 sites

Local Institution
Aguascalientes, Aguascalientes, 20230
Local Institution
Monterrey, Nuevo León, 64460

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Philippines2 sites

Local Institution
Cebu City, 6000
Local Institution
Marikina City, 1800

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Argentina1 site

Local Institution
Martínez, Buenos Aires, B1640AOD

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Italy1 site

Local Institution
Milan, 20132

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Puerto Rico1 site

Local Institution
Ponce, Puerto Rico, 00717

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About this study

Official title: A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/Day

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Conditions: Type 2 Diabetes
Being tested: Saxagliptin, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

SaxagliptinDrug
Also called BMS-477118
Tablets, Oral, 5mg, once daily, 4 weeks
PlaceboDrug
Tablets, Oral, 0 mg, once daily, 4 weeks

Study groups in NCT00683657
Study group	Role	What they receive
Saxagliptin 5 mg + Metformin	Experimental	Not described Receives: Drug: Saxagliptin
Placebo + Metformin	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
Measured: Baseline, Week 4

Secondary outcomes (4)

Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Measured: Baseline, Week 4
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Measured: Baseline, Week 4
Change From Baseline in Mean Daily Glucose at Week 4
Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.
Measured: Baseline, Week 4
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.
Measured: Baseline, Week 4

Timeline

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

Jul 2008Feb 2009

First posted23 May 2008 (estimated)
Study startJul 2008
Primary completionFeb 2009
Study completionFeb 2009

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.
Other trials for Type 2 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: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00683657
Sponsor's protocol ID: CV181-066
Other IDs: Eudract-2008-000976-26
Status last verified: May 2015
First submitted: 21 May 2008
Last updated: 1 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/Day
ClinicalTrials.gov ID: NCT00683657
Acronym / sponsor ID: CV181-066
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 23 May 2008 (estimated)
Results: Posted 10 Mar 2010

Clinical summary

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

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Saxagliptin 5 mg + Metformin	Experimental	Drug: Saxagliptin
Placebo + Metformin	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (5 listed)

≥18- and ≤77-years-old
Type 2 diabetes
Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
Glycosylated hemoglobin (A1C) ≥7% and ≤10%
Body mass index (BMI) ≤40 kg/m2

Key exclusion criteria (5 listed)

Women of childbearing potential unable or unwilling to use acceptable birth control
Women who are pregnant or breastfeeding
Significant cardiovascular history
Active liver disease
Renal impairment

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-477118Tablets, Oral, 5mg, once daily, 4 weeks	Drug	Saxagliptin 5 mg + Metformin
PlaceboTablets, Oral, 0 mg, once daily, 4 weeks	Drug	Placebo + Metformin

Primary outcome

Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Time frame: Baseline, Week 4
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.

4 secondary outcomes

Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
Time frame: Baseline, Week 4
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Mean Daily Glucose at Week 4
Time frame: Baseline, Week 4
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
Time frame: Baseline, Week 4

Results and safety

Results posted to the registry on 10 Mar 2010, 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	46	45
Placebo + Metformin	47	46

Primary outcome: Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4

Time frame: Baseline, Week 4. Mean (Standard Error). Unit: mg/dL

Measure	Saxagliptin 5 mg + Metformin n = 41	Placebo + Metformin n = 44
Baseline Mean	177.5 (4.99)	181.2 (6.30)
Week 4 Mean	163.8 (5.09)	184.2 (7.05)
Adjusted Mean Change from Baseline	-13.8 (2.99)	3.0 (2.89)

Saxagliptin 5 mg + Metformin vs Placebo + Metformin: Mean Difference (Final Values): -16.8 (95% CI -25.1 to -8.5), p = 0.0001, ANCOVA

Population analysed: Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.

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 + MET	0 of 47 (0%)	5 of 47 (10.6%)	Not reported
SAXA 5MG + MET	0 of 46 (0%)	1 of 46 (2.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
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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

27 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 27 sites in 8 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 5 inclusion and 5 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Israel, Sweden, Mexico, Philippines and 3 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. 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 10 Mar 2010). 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 24-Hour Mean Weighted Glucose (MWG) at Week 4 (time frame: Baseline, Week 4). 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 NCT00683657.

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 1 Jun 2015.