Type 2 Diabetes MellitusPhase 3NCT00359762

Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

A Phase 3 study testing exenatide and glimepiride in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 114 sites in 14 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

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: exenatide and glimepiride
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,029 participants
Where: 114 sitesin 14 countries
Study dates: Sep 2006to Mar 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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with type 2 diabetes mellitus.
Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
HbA1c >=6.5% and <=9.0%.
Body Mass Index (BMI) >=25 kg/m^2 and <40 kg/m^2.

Who cannot join

Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
Characteristics contraindicating metformin or glimepiride use.
Receiving drugs that directly affect gastrointestinal motility.
Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
Have used any prescription drug to promote weight loss within 3 months prior to screening.
Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: *insulin; *thiazolidinediones; *alpha-glucosidase inhibitors; *sulfonylurea; *meglitinides

Trial locations and contacts

114 sites in 14 countries.

Country

City, postcode or hospital

114 sites in 14 countries

Italy23 sites

Research Site
Ancona
Research Site
Arenzano
Research Site
Atri
Research Site
Bergamo
Research Site
Catanzaro
Research Site
Florence
Research Site
Foggia
Research Site
Forlì
Research Site
Genova
Research Site
Grosseto
Research Site
Milan
Research Site
Monserrato (Cagliari)
Research Site
Naples
Research Site
Palermo
Research Site
Perugia
Research Site
Pescara
Research Site
Pisa
Research Site
Ravenna
Research Site
Roma
Research Site
San Benedetto del Tronto
Research Site
Siena
Research Site
Treviso
Research Site
Verona

Other trials in Italy

Germany19 sites

Research Site
Altona
Research Site
Aschaffenburg
Research Site
Bad Staffelstein
Research Site
Dresden
Research Site
Eisenach
Research Site
Essen
Research Site
Essen Schonnebeck
Research Site
Falkensee
Research Site
Fulda
Research Site
Hamburg
Research Site
Hamburg-Ottmarschen
Research Site
Heidelberg
Research Site
Leipzig
Research Site
Münster
Research Site
Saarbrücken
Research Site
Saint Ingbert
Research Site
Schenklengsfeld
Research Site
Schkeuditz
Research Site
Witten

Other trials in Germany

France17 sites

Research Site
Alençon
Research Site
Bois-Guillaume
Research Site
Bourg-des-Comptes
Research Site
Broglie
Research Site
Bron
Research Site
Fléville-devant-Nancy
Research Site
Le Creusot
Research Site
Le Mans
Research Site
Loudun
Research Site
Montigny-lès-Metz
Research Site
Nevers
Research Site
Strasbourg
Research Site
Thouars
Research Site
Tours
Research Site
Valréas
Research Site
Vénissieux
Research Site
Vihiers

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United Kingdom12 sites

Research Site
Bath
Research Site
Belfast
Research Site
Brandford on Avon
Research Site
County Antrim
Research Site
Downpatrick
Research Site
Frome
Research Site
Midsomer Norton
Research Site
Omagh
Research Site
Penzance
Research Site
Plymouth
Research Site
Southdown
Research Site
Wiltshire

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Czechia7 sites

Research Site
Beroun
Research Site
České Budějovice
Research Site
Hradec Králové
Research Site
Liberec
Research Site
Písek
Research Site
Prague
Research Site
Třebíč

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Poland6 sites

Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Lublin
Research Site
Szczecin
Research Site
Warsaw
Research Site
Wroclaw

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Hungary5 sites

Research Site
Budapest
Research Site
Gyula
Research Site
Kecskemét
Research Site
Veszprém
Research Site
Zalaegerszeg

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Austria4 sites

Research Site
Graz
Research Site
Innsbruck
Research Site
Salzburg
Research Site
Vienna

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Finland4 sites

Research Site
Helsinki
Research Site
Kuopio
Research Site
Pori
Research Site
Vaasa

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Israel4 sites

Research Site
Haifa
Research Site
Holon
Research Site
Jerusalem
Research Site
Tel HaShomer

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Mexico4 sites

Research Site
Celaya, Guanajuato
Research Site
Mexico City, Mexico City
Research Site
Monterrey, Nuevo León
Research Site
Pachuca, Hidalgo

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Switzerland4 sites

Research Site
Fribourg
Research Site
Geneva
Research Site
Lausanne
Research Site
Lucerne

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Ireland3 sites

Research Site
County Galway
Research Site
County Waterford
Research Site
Dublin

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Spain2 sites

Research Site
Barcelona
Research Site
Madrid

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About this study

Official title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

Conditions: Type 2 Diabetes Mellitus
Being tested: exenatide, glimepiride
Keywords: exenatide, diabetes, Amylin, Lilly, glimepiride
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

exenatideDrug
Also called Byetta
subcutaneous injection (5mcg or 10mcg), twice a day
glimepirideDrug
Also called Amaryl
oral tablet (titrated to maximally tolerated dose), once daily

Study groups in NCT00359762
Study group	Role	What they receive
Exenatide	Experimental	Not described Receives: Drug: exenatide
Glimepiride	Active comparator	Not described Receives: Drug: glimepiride

What is being measured

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

Number of Patients With Treatment Failure
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.
Measured: Baseline to end of Period II (up to 4.5 years)
Time to Treatment Failure
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.
Measured: Baseline to end of Period II (up to 4.5 years)

Secondary outcomes (25)

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3
HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).
Measured: Year 3 in Period II
Change in HOMA-B From Baseline to Endpoint
Change in HOMA-B from baseline to endpoint.
Measured: Baseline, end of Period II (up to 4.5 years)
Fasting Proinsulin/Insulin Ratio at Year 3
Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.
Measured: Year 3 in Period II
Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.
Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.
Measured: Baseline, end of Period II (up to 4.5 years)
Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3
DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).
Measured: Year 3 in Period II
Change in DI30/DG30 Ratio From Baseline to Endpoint
Change in DI30/DG30 ratio from baseline to endpoint.
Measured: Baseline, end of Period II (up to 4.5 years)
Disposition Index at Year 3
Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).
Measured: Year 3 in Period II
Change in Disposition Index From Baseline to Endpoint
Change in disposition index from baseline to endpoint.
Measured: Baseline, end of Period II (up to 4.5 years)
Change in HbA1c From Baseline to Year 3
Change in HbA1c from baseline to Year 3.
Measured: Baseline, Year 3 in Period II
Change in HbA1c From Baseline to Endpoint
Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).
Measured: Baseline, end of Period II (up to 4.5 years)
Fasting Plasma Glucose at Year 3
Fasting plasma glucose at Year 3.
Measured: Year 3 in Period II
Change in Fasting Plasma Glucose From Baseline to Endpoint
Change in fasting plasma glucose from baseline to endpoint.
Measured: Baseline, end of Period II (up to 4.5 years)
Postprandial (2 Hours) Plasma Glucose at Year 3
Postprandial (2 hours) plasma glucose at Year 3.
Measured: Year 3 in Period II
Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint
Change from baseline in postprandial (2 hours) plasma glucose to endpoint.
Measured: Baseline, end of Period II (up to 4.5 years)
Change in Body Weight From Baseline to Year 3
Change in Body weight from baseline to Year 3.
Measured: Baseline, Year 3 in Period II
Systolic Blood Pressure at Year 3
Systolic Blood pressure at Year 3.
Measured: Year 3 in Period II
Diastolic Blood Pressure at Year 3
Diastolic Blood pressure at Year 3.
Measured: Year 3 in Period II
Heart Rate at Year 3
Heart rate at Year 3.
Measured: Year 3 in Period II
Triglycerides at Year 3
Triglycerides at Year 3.
Measured: Year 3 in Period II
Total Cholesterol at Year 3
Total Cholesterol at Year 3.
Measured: Year 3 in Period II
High-density Lipoprotein (HDL) Cholesterol at Year 3
HDL Cholesterol at Year 3.
Measured: Year 3 in Period II
Hypoglycemia Rate Per Year
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Measured: Baseline to end of Period II (up to 4.5 years)
Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III
Change in HbA1c from baseline to Year 2.
Measured: Baseline in Period III, Year 2 in Period III
Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III
Change in HbA1c from baseline to Year 2.
Measured: Baseline in Period III, Year 2 in Period III
Hypoglycemia Rate Per Year in Period III
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Measured: Start of Period III to end of study

Timeline

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

Sep 2006Mar 2011

First posted2 Aug 2006 (estimated)
Study startSep 2006
Primary completionMar 2011
Study completionMar 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.
Publications (3)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,029 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00359762
Sponsor's protocol ID: H8O-EW-GWBE
Status last verified: Aug 2015
First submitted: 31 Jul 2006
Last updated: 15 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Simo R, Guerci B, Schernthaner G, Gallwitz B, Rosas-Guzman J, Dotta F, Festa A, Zhou M, Kiljanski J. Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z.
PubMed 26338040
Schernthaner G, Rosas-Guzman J, Dotta F, Guerci B, Simo R, Festa A, Kiljanski J, Zhou M, Gallwitz B. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471. Epub 2015 May 8.
PubMed 25846577
Gallwitz B, Guzman J, Dotta F, Guerci B, Simo R, Basson BR, Festa A, Kiljanski J, Sapin H, Trautmann M, Schernthaner G. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012 Jun 16;379(9833):2270-8. doi: 10.1016/S0140-6736(12)60479-6. Epub 2012 Jun 9.
PubMed 22683137

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 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)
ClinicalTrials.gov ID: NCT00359762
Acronym / sponsor ID: H8O-EW-GWBE
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide, diabetes, Amylin, Lilly, glimepiride
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,029 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Sep 2006
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 2 Aug 2006 (estimated)
Results: Posted 14 Mar 2013

Clinical summary

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

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Exenatide	Experimental	Drug: exenatide
Glimepiride	Active comparator	Drug: glimepiride

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with type 2 diabetes mellitus.
Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
HbA1c >=6.5% and <=9.0%.
Body Mass Index (BMI) >=25 kg/m^2 and <40 kg/m^2.

Key exclusion criteria (6 listed)

Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
Characteristics contraindicating metformin or glimepiride use.
Receiving drugs that directly affect gastrointestinal motility.
Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
Have used any prescription drug to promote weight loss within 3 months prior to screening.

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
exenatideAlso: Byettasubcutaneous injection (5mcg or 10mcg), twice a day	Drug	Exenatide
glimepirideAlso: Amaryloral tablet (titrated to maximally tolerated dose), once daily	Drug	Glimepiride

Primary outcome

Number of Patients With Treatment Failure
Time frame: Baseline to end of Period II (up to 4.5 years)
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.
Time to Treatment Failure
Time frame: Baseline to end of Period II (up to 4.5 years)
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.

25 secondary outcomes

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3
Time frame: Year 3 in Period II
Change in HOMA-B From Baseline to Endpoint
Time frame: Baseline, end of Period II (up to 4.5 years)
Fasting Proinsulin/Insulin Ratio at Year 3
Time frame: Year 3 in Period II
Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.
Time frame: Baseline, end of Period II (up to 4.5 years)
Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3
Time frame: Year 3 in Period II
Change in DI30/DG30 Ratio From Baseline to Endpoint
Time frame: Baseline, end of Period II (up to 4.5 years)
Disposition Index at Year 3
Time frame: Year 3 in Period II
Change in Disposition Index From Baseline to Endpoint
Time frame: Baseline, end of Period II (up to 4.5 years)
Change in HbA1c From Baseline to Year 3
Time frame: Baseline, Year 3 in Period II
Change in HbA1c From Baseline to Endpoint
Time frame: Baseline, end of Period II (up to 4.5 years)
Fasting Plasma Glucose at Year 3
Time frame: Year 3 in Period II
Change in Fasting Plasma Glucose From Baseline to Endpoint
Time frame: Baseline, end of Period II (up to 4.5 years)
Postprandial (2 Hours) Plasma Glucose at Year 3
Time frame: Year 3 in Period II
Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint
Time frame: Baseline, end of Period II (up to 4.5 years)
Change in Body Weight From Baseline to Year 3
Time frame: Baseline, Year 3 in Period II
Systolic Blood Pressure at Year 3
Time frame: Year 3 in Period II
Diastolic Blood Pressure at Year 3
Time frame: Year 3 in Period II
Heart Rate at Year 3
Time frame: Year 3 in Period II
Triglycerides at Year 3
Time frame: Year 3 in Period II
Total Cholesterol at Year 3
Time frame: Year 3 in Period II
High-density Lipoprotein (HDL) Cholesterol at Year 3
Time frame: Year 3 in Period II
Hypoglycemia Rate Per Year
Time frame: Baseline to end of Period II (up to 4.5 years)
Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III
Time frame: Baseline in Period III, Year 2 in Period III
Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III
Time frame: Baseline in Period III, Year 2 in Period III
Hypoglycemia Rate Per Year in Period III
Time frame: Start of Period III to end of study

Results and safety

Results posted to the registry on 14 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period II, Glim + Met	514	386
Period III, Exen + Met + Glim - Randomized	0	0
Period III, Exen + Met + Pio or Rosi - Randomized	0	0
Period III, Glim + Met + Exen - Not Randomized	0	0
Period II, Exen + Met	515	341

Primary outcome: Number of Patients With Treatment Failure

Time frame: Baseline to end of Period II (up to 4.5 years). Number. Unit: number of patients

Measure	Exen + Met n = 490	Glim + Met n = 487
Number of patients with treatment failure	203	262
Number of patients censored	287	225

Exen + Met vs Glim + Met: Hazard Ratio: 0.748 (95% CI 0.623 to 0.899), p = 0.0020, Regression, Cox

Population analysed: ITT Efficacy Population: Enrolled patients with a baseline and at least one post-baseline measurement of HbA1c in Study Period II (including only Study Period II); patients analyzed according to treatment as randomized.

Primary outcome: Time to Treatment Failure

Time frame: Baseline to end of Period II (up to 4.5 years). Median (95% Confidence Interval). Unit: week

Measure	Exen + Met n = 490	Glim + Met n = 487
Value	180.0 (140.9 to NA)	142.1 (118.6 to 161.1)

Exen + Met vs Glim + Met: p = 0.0315, Log Rank

Population analysed: ITT Efficacy Population.

25 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
Period II, Glim + Met	68 of 508 (13.4%)	248 of 508 (48.8%)	Not reported
Period III, Exen + Met + Glim - Randomized	7 of 74 (9.5%)	39 of 74 (52.7%)	Not reported
Period III, Exen + Met + Pio or Rosi - Randomized	13 of 76 (17.1%)	39 of 76 (51.3%)	Not reported
Period III, Glim + Met + Exen - Not Randomized	19 of 166 (11.4%)	91 of 166 (54.8%)	Not reported
Period II, Exen + Met	73 of 511 (14.3%)	311 of 511 (60.9%)	Not reported

Limitations and caveats (from the sponsor): Only patients who reached primary endpoint 12 months or more before the projected end of the study could enter period III.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26338040Simo R, Guerci B, Schernthaner G, Gallwitz B, Rosas-Guzman J, Dotta F, Festa A, Zhou M, Kiljanski J. Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z.
Derived from this study: PubMed 25846577Schernthaner G, Rosas-Guzman J, Dotta F, Guerci B, Simo R, Festa A, Kiljanski J, Zhou M, Gallwitz B. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471. Epub 2015 May 8.
Derived from this study: PubMed 22683137Gallwitz B, Guzman J, Dotta F, Guerci B, Simo R, Basson BR, Festa A, Kiljanski J, Sapin H, Trautmann M, Schernthaner G. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012 Jun 16;379(9833):2270-8. doi: 10.1016/S0140-6736(12)60479-6. Epub 2012 Jun 9.

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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.

James Malone, MD study director

Eli Lilly and Company

114 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide and glimepiride in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 114 sites in 14 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 4 inclusion and 6 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 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Italy, Germany, France, United Kingdom, Czechia and 9 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 14 Mar 2013). 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?

Number of Patients With Treatment Failure (time frame: Baseline to end of Period II (up to 4.5 years)). 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 NCT00359762, 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 15 Sep 2015.