Type 2 Diabetes MellitusPhase 4PROMPTNCT01006590

Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

A Phase 4 study testing Saxagliptin and Metformin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 51 sites in 7 countries.

Completed

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

Official record

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Trial summary

The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Saxagliptin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 286 participants
Where: 51 sitesin 7 countries
Study dates: Oct 2009to Dec 2010
Phase: Phase 4
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

Provision of signed informed consent
Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
HbA1c ≥7.0% and ≤10.0%

Who cannot join

Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study

Trial locations and contacts

51 sites in 7 countries.

Country

City, postcode or hospital

51 sites in 7 countries

Belgium9 sites

Research Site
Bruges
Research Site
Brussels (woluwe-st-lambert), Belgium
Research Site
Halen, Belgium
Research Site
Lommel, Belgium
Research Site
Moerkerke
Research Site
Oostham, Belgium
Research Site
Sint-Gillis-Waas, Belgium
Research Site
Tielt
Research Site
Zoersel, Belgium

Other trials in Belgium

United Kingdom9 sites

Research Site
Ashford
Research Site
Atherstone, Warwickshire
Research Site
Bath
Research Site
Coventry
Research Site
Peterborough
Research Site
Reading, Berks
Research Site
Royal Leamington Spa, Warwks
Research Site
Warminster, Wiltshire
Research Site
Westbury, Wiltshire

Other trials in United Kingdom

Germany8 sites

Research Site
Berlin
Research Site
Freiburg im Breisgau
Research Site
Leipzig
Research Site
Ludwigshafen
Research Site
Mannheim
Research Site
Rhaunen
Research Site
Schmiedeberg
Research Site
Wahlstedt

Other trials in Germany

France7 sites

Research Site
Châtellerault
Research Site
Corbeil-Essonnes
Research Site
La Rochelle
Research Site
La Seyne-sur-Mer
Research Site
Paris
Research Site
Seysses
Research Site
Tiercé

Other trials in France

Italy7 sites

Research Site
Bergamo, BG
Research Site
Forlì, FC
Research Site
Milan, MI
Research Site
Padova, PD
Research Site
Pordenone, PN
Research Site
Roma
Research Site
Siena, SI

Other trials in Italy

Spain7 sites

Research Site
A Coruña, Galicia
Research Site
Alicante, Valencia
Research Site
Barcelona, Catalonia
Research Site
Madrid, Madrid
Research Site
Oviedo, Principality of Asturias
Research Site
San Sebastián de los Reyes, Madrid
Research Site
Seville, Andalusia

Other trials in Spain

Turkey (Türkiye)4 sites

Research Site
Ankara, Turkey
Research Site
Ankara
Research Site
Bursa, Turkey
Research Site
Kirikkale, Turkey

Other trials in Turkey (Türkiye)

About this study

Official title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

Conditions: Type 2 Diabetes Mellitus
Being tested: Saxagliptin, Metformin
Keywords: Type 2 Diabetes Mellitus, Saxagliptin, Randomised, Double-blind
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, oral tablet, once daily
MetforminDrug
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy

Study groups in NCT01006590
Study group	Role	What they receive
1	Experimental	Saxagliptin 5 mg Receives: Drug: Saxagliptin
2	Active comparator	Metformin 500 -1000 mg Receives: Drug: Metformin

What is being measured

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

Absolute Change From Baseline in HbA1c at Week 24
Measured: Baseline and 24 weeks

Secondary outcomes (5)

Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent
Measured: 24 Weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent
Measured: 24 Weeks
Change From Baseline to Week 24 in Fasting Plasma Glucose
Measured: Baseline and 24 weeks
Change From Baseline to Week 24 in Fasting Insulin
Measured: Baseline and 24 weeks
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
Measured: Baseline and 24 weeks

Timeline

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

Oct 2009Dec 2010

First posted3 Nov 2009 (estimated)
Study startOct 2009
Study completionDec 2010

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 (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 286 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01006590
Sponsor's protocol ID: D1680L00003
Acronym: PROMPT
Status last verified: Jan 2012
First submitted: 31 Oct 2009
Last updated: 19 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.
PubMed 23020253

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 Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin
ClinicalTrials.gov ID: NCT01006590
Acronym / sponsor ID: PROMPT / D1680L00003
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Saxagliptin, Randomised, Double-blind
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 286 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Oct 2009
Study completion: Dec 2010 (actual)
First posted: 3 Nov 2009 (estimated)
Results: Posted 5 Jan 2012

Clinical summary

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

Study design

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

Arm	Type	Receives
1	Experimental	Drug: SaxagliptinSaxagliptin 5 mg
2	Active comparator	Drug: MetforminMetformin 500 -1000 mg

Who may qualify

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

Key inclusion criteria (3 listed)

Provision of signed informed consent
Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
HbA1c ≥7.0% and ≤10.0%

Key exclusion criteria (3 listed)

Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study

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, oral tablet, once daily	Drug	1
Metformin500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy	Drug	2

Primary outcome

Absolute Change From Baseline in HbA1c at Week 24
Time frame: Baseline and 24 weeks

5 secondary outcomes

Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
Time frame: 24 Weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
Time frame: 24 Weeks
Change From Baseline to Week 24 in Fasting Plasma Glucose
Time frame: Baseline and 24 weeks
Change From Baseline to Week 24 in Fasting Insulin
Time frame: Baseline and 24 weeks
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 5 Jan 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	147	119
Metformin Uptitration	139	107

Primary outcome: Absolute Change From Baseline in HbA1c at Week 24

Time frame: Baseline and 24 weeks. Mean (Standard Error). Unit: Percent (%)

Measure	Saxagliptin n = 146	Metformin Uptitration n = 137
Value	-0.47 (0.06)	-0.38 (0.06)

Saxagliptin vs Metformin Uptitration: Mean Difference (Net): -0.10 (95% CI -0.26 to 0.07), p = 0.26, ANCOVA

5 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
Saxagliptin	6 of 147 (4.1%)	27 of 147 (18.4%)	Not reported
Metformin Uptitration	6 of 139 (4.3%)	22 of 139 (15.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23020253Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have 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.

The record lists no contact. Use the official record to reach the sponsor.

51 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin and Metformin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 51 sites in 7 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 3 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Belgium, United Kingdom, Germany, France, Italy and 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Jan 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?

Absolute Change From Baseline in HbA1c at Week 24 (time frame: Baseline and 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 NCT01006590, which also lists 1 linked publication.

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 19 Jan 2012.