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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

NCTNCT00359762 (opens ClinicalTrials.gov in a new tab)Other idH8O-EW-GWBE
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,029 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
14 countries

Austria, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Mexico, Poland, Spain, Switzerland, United Kingdom

Start
Sept 2006
Primary completion
Mar 2011
Completion
Mar 2011
First posted
2 Aug 2006 (estimated)
Last update posted
15 Sept 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009201020112012
  1. Ph 3

    Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

    NCT00359762

    Sept 2006 to Mar 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatideDrug
  • glimepirideDrug

Arms2

  • Experimental

    Exenatide

  • Active comparator

    Glimepiride

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Patients With Treatment Failure

    Time frame · Baseline to end of Period II (up to 4.5 years)

    Registry description

    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.

  2. Time to Treatment Failure

    Time frame · Baseline to end of Period II (up to 4.5 years)

    Registry description

    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.

Secondary outcomes(20)

  1. Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3

    Time frame · Year 3 in Period II

    Registry description

    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).

  2. Change in HOMA-B From Baseline to Endpoint

    Time frame · Baseline, end of Period II (up to 4.5 years)

    Registry description

    Change in HOMA-B from baseline to endpoint.

  3. Fasting Proinsulin/Insulin Ratio at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.

  4. Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.

    Time frame · Baseline, end of Period II (up to 4.5 years)

    Registry description

    Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.

  5. 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

    Registry description

    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).

  6. Change in DI30/DG30 Ratio From Baseline to Endpoint

    Time frame · Baseline, end of Period II (up to 4.5 years)

    Registry description

    Change in DI30/DG30 ratio from baseline to endpoint.

  7. Disposition Index at Year 3

    Time frame · Year 3 in Period II

    Registry description

    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).

  8. Change in Disposition Index From Baseline to Endpoint

    Time frame · Baseline, end of Period II (up to 4.5 years)

    Registry description

    Change in disposition index from baseline to endpoint.

  9. Change in HbA1c From Baseline to Year 3

    Time frame · Baseline, Year 3 in Period II

    Registry description

    Change in HbA1c from baseline to Year 3.

  10. Change in HbA1c From Baseline to Endpoint

    Time frame · Baseline, end of Period II (up to 4.5 years)

    Registry description

    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).

  11. Fasting Plasma Glucose at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Fasting plasma glucose at Year 3.

  12. Change in Fasting Plasma Glucose From Baseline to Endpoint

    Time frame · Baseline, end of Period II (up to 4.5 years)

    Registry description

    Change in fasting plasma glucose from baseline to endpoint.

  13. Postprandial (2 Hours) Plasma Glucose at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Postprandial (2 hours) plasma glucose at Year 3.

  14. Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint

    Time frame · Baseline, end of Period II (up to 4.5 years)

    Registry description

    Change from baseline in postprandial (2 hours) plasma glucose to endpoint.

  15. Change in Body Weight From Baseline to Year 3

    Time frame · Baseline, Year 3 in Period II

    Registry description

    Change in Body weight from baseline to Year 3.

  16. Systolic Blood Pressure at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Systolic Blood pressure at Year 3.

  17. Diastolic Blood Pressure at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Diastolic Blood pressure at Year 3.

  18. Heart Rate at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Heart rate at Year 3.

  19. Triglycerides at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Triglycerides at Year 3.

  20. Total Cholesterol at Year 3

    Time frame · Year 3 in Period II

    Registry description

    Total Cholesterol at Year 3.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline to end of Period II (up to 4.5 years)

Number of Patients With Treatment Failure

GroupValue (number of patients)
Exen + Met203
Glim + Met262
Primary outcomeMedian· Baseline to end of Period II (up to 4.5 years)

Time to Treatment Failure

GroupValue (week)
Exen + Met180.0
Glim + Met142.1
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Year 3 in Period II

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3

GroupValue (ratio)Spread
Exen + Met66.864.045
Glim + Met68.523.813
Secondary outcomeLeast squares mean· Baseline, end of Period II (up to 4.5 years)

Change in HOMA-B From Baseline to Endpoint

GroupValue (ratio)Spread
Exen + Met5.566.147
Glim + Met19.926.340
Secondary outcomeLeast squares mean· Year 3 in Period II

Fasting Proinsulin/Insulin Ratio at Year 3

GroupValue (ratio)Spread
Exen + Met0.220.023
Glim + Met0.230.022
Secondary outcomeLeast squares mean· Baseline, end of Period II (up to 4.5 years)

Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.

GroupValue (ratio)Spread
Exen + Met0.030.014
Glim + Met0.050.015
Secondary outcomeLeast squares mean· Year 3 in Period II

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

GroupValue (ratio)Spread
Exen + Met25.813.323
Glim + Met26.383.032
Secondary outcomeLeast squares mean· Baseline, end of Period II (up to 4.5 years)

Change in DI30/DG30 Ratio From Baseline to Endpoint

GroupValue (ratio)Spread
Exen + Met12.104.115
Glim + Met0.914.299

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Period II, Glim + MetGlimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin–68 / 508248 / 508
Period III, Exen + Met + Glim - RandomizedGlimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III–7 / 7439 / 74
Period III, Exen + Met + Pio or Rosi - RandomizedOral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III–13 / 7639 / 76
Period III, Glim + Met + Exen - Not RandomizedExenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III–19 / 16691 / 166
Period II, Exen + MetExenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin–73 / 511311 / 511

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2015

3 results

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.

Schernthaner et al. 2015Diabetes, obesity & metabolismcited by 4

PMID 25846577DOI 10.1111/dom.12471PUB-25846577

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2015

12 results

Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study.

Simó et al. 2015Cardiovascular diabetologycited by 44

PMID 26338040PMC4558893DOI 10.1186/s12933-015-0279-zPUB-26338040

CC BY12 results
Download PDFSee results (12)

Indexing hint: Randomized controlled trial · 2012

10 results

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.

Gallwitz et al. 2012Lancet (London, England)cited by 130

PMID 22683137DOI 10.1016/s0140-6736(12)60479-6PUB-22683137

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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

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