Saxagliptin Triple Oral Therapy

A Phase 3 study testing Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 33 sites in 6 countries.

Completed

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

Trial summary

The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated. Read more about this study

Who is it for?: Ages 18 years and older
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: 257 participants
Where: 33 sitesin 6 countries
Study dates: Jun 2010to Jun 2011
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written Informed Consent
Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and < or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
BMI < or = 40 kg/m2

Who cannot join

Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other signs and symptoms
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
Estimated CrCl < 60 ml/min at Visit 2
CHF (NYHA class III or IV) and/or LVEF <40%
Active liver disease and/or significant abnormal liver function defined as AST and/or ALT > 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit 2.
Creatine kinase > or = 10 x ULN at Visit 2

Trial locations and contacts

33 sites in 6 countries.

Country

City, postcode or hospital

33 sites in 6 countries

United Kingdom12 sites

Research Site
Ashford
Research Site
Belfast
Research Site
Blackpool
Research Site
Chesterfield
Research Site
Coventry
Research Site
Ely, Cambridgeshire
Research Site
Glasgow
Research Site
Peterborough
Research Site
Reading, Berks
Research Site
Wellingborough
Research Site
Westbury, Wiltshire
Research Site
Whitstable, Kent

Other trials in United Kingdom

Australia7 sites

Research Site
Broadmeadow, New South Wales
Research Site
Camperdown
Research Site
Daw Park, South Australia
Research Site
Elizabeth Vale, South Australia
Research Site
Herston
Research Site
Melbourne, Victoria
Research Site
Wollongong, New South Wales

Other trials in Australia

India5 sites

Research Site
Bangalore, Karnataka
Research Site
Coimbatore, Tamil Nadu
Research Site
Indore, Madhya Pradesh
Research Site
Karnāl, Haryana
Research Site
Pune, Maharashtra

Other trials in India

Canada4 sites

Research Site
Kensington, Prince Edward Island
Research Site
St. John's, Newfoundland and Labrador
Research Site
Sydney Mines, Nova Scotia
Research Site
Thornhill, Ontario

Other trials in Canada

South Korea4 sites

Research Site
Daegu
Research Site
Goyang, Kyounggi-do
Research Site
Seoul
Research Site
Wŏnju, Gangwon-do

Other trials in South Korea

Thailand1 site

Research Site
Bangkok

Other trials in Thailand

About this study

Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin and Sulfonylurea in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Combination of Metformin and Sulfonylurea

Read the detailed description

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

Conditions: Type 2 Diabetes
Being tested: Saxagliptin, Placebo
Keywords: Type 2 Diabetes, Inadequate Glycaemic Control, Saxagliptin, Metformin, Sulfonylurea, Triple Oral Therapy
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 Onglyza
5 mg tablet once daily for 24 weeks to be taken orally
PlaceboDrug
tablet once daily for 24 weeks to be taken orally

Study groups in NCT01128153
Study group	Role	What they receive
Saxagliptin 5 mg once daily	Experimental	Not described Receives: Drug: Saxagliptin
Placebo once daily	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 in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
Measured: From Baseline to Week 24 weeks

Secondary outcomes (5)

Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Measured: From Baseline to Week 24
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Measured: From Baseline to Week 24
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance
Measured: From Baseline to Week 24
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model
Measured: From Baseline to Week 24
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24
Measured: From Baseline to Week 24

Timeline

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

Jun 2010Jun 2011

First posted21 May 2010 (estimated)
Study startJun 2010
Primary completionJun 2011
Study completionJun 2011

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 257 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01128153
Sponsor's protocol ID: D1680L00006
Other IDs: CV181-117
Status last verified: Aug 2012
First submitted: 20 May 2010
Last updated: 10 Aug 2012
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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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin and Sulfonylurea in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Combination of Metformin and Sulfonylurea
ClinicalTrials.gov ID: NCT01128153
Acronym / sponsor ID: D1680L00006
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, Inadequate Glycaemic Control, Saxagliptin, Metformin, Sulfonylurea, Triple Oral Therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 257 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Jun 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 21 May 2010 (estimated)
Results: Posted 3 Aug 2012

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Saxagliptin 5 mg once daily	Experimental	Drug: Saxagliptin
Placebo once daily	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (3 listed)

Written Informed Consent
Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and < or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
BMI < or = 40 kg/m2

Key exclusion criteria (8 listed)

Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other signs and symptoms
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
Estimated CrCl < 60 ml/min at Visit 2

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: Onglyza5 mg tablet once daily for 24 weeks to be taken orally	Drug	Saxagliptin 5 mg once daily
Placebotablet once daily for 24 weeks to be taken orally	Drug	Placebo once daily

Primary outcome

Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
Time frame: From Baseline to Week 24 weeks
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model

5 secondary outcomes

Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Time frame: From Baseline to Week 24
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Time frame: From Baseline to Week 24
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Time frame: From Baseline to Week 24
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Time frame: From Baseline to Week 24
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
Time frame: From Baseline to Week 24

Results and safety

Results posted to the registry on 3 Aug 2012, 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	129	113
PLACEBO	128	113

Primary outcome: Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)

Time frame: From Baseline to Week 24 weeks. Mean (95% Confidence Interval). Unit: percent

Measure	Arm 1 - SAXAGLIPTIN n = 127	Arm 2 - PLACEBO n = 127
Value	-0.74 (-0.89 to -0.60)	-0.08 (-0.23 to 0.07)

Arm 1 - SAXAGLIPTIN vs Arm 2 - PLACEBO: Mean Difference (Final Values): -0.66 (95% CI -0.86 to -0.47), p <0.0001, ANCOVA

Population analysed: Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAXAGLIPTIN	3 of 129 (2.3%)	53 of 129 (41.1%)	Not reported
PLACEBO	7 of 128 (5.5%)	65 of 128 (50.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
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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.

Jayanti Visvanthan, MD study chair

AstraZeneca

Simon Fisher, MD study chair

AstraZeneca

Vinod Mattoo, MD study chair

Bristol-Myers Squibb

33 sites in 6 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 33 sites in 6 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 8 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 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United Kingdom, Australia, India, Canada, South Korea and 1 more country. 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 3 Aug 2012). 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 in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF) (time frame: From Baseline to Week 24 weeks). 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 NCT01128153.

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 10 Aug 2012.