Phase 3 · Exenatide

NCT00359762 trial results

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

Time to Treatment Failure (week), Baseline to end of Period II (up to 4.5 years). Exen + Met: 180.0; Glim + Met: 142.1.

Participants: 1,029
Status: completed
Completed: 2011-03
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT00359762), updated at source Sep 15, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00359762 measured first

Number of Patients With Treatment Failurenumber of patients · Baseline to end of Period II (up to 4.5 years) · number

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

Time to Treatment Failureweek · Baseline to end of Period II (up to 4.5 years) · median

Exen + Metn=490	Glim + Metn=487
180.0(140.9 to NA)	142.1(118.6 to 161.1)

Side effects by arm

Side effects in NCT00359762

Percent of participants affected. The most common events the registry lists.

Event	Period II, Glim + Met	Period III, Exen + Met + Glim - Randomized	Period III, Exen + Met + Pio or Rosi - Randomized	Period III, Glim + Met + Exen - Not Randomized	Period II, Exen + Met
Any serious event	13.4%	9.5%	17.1%	11.4%	14.3%
Nausea	2.2%	13.5%	11.8%	22.9%	28.8%
Nasopharyngitis	18.3%	27%	19.7%	16.3%	18.8%
Headache	9.4%	14.9%	9.2%	6%	11%
Diarrhoea	6.5%	9.5%	9.2%	7.8%	12.1%
Back pain	10.6%	6.8%	11.8%	5.4%	10.2%
Influenza	6.9%	9.5%	7.9%	4.8%	10.6%
Bronchitis	6.1%	2.7%	9.2%	3%	6.7%
Vomiting	2.4%	5.4%	1.3%	7.8%	8.6%
Dyspepsia	2.8%	5.4%	0%	8.4%	5.1%
Abdominal pain upper	2.6%	8.1%	2.6%	3.6%	4.1%
Arthralgia	8.1%	2.7%	2.6%	3.6%	4.1%
Hypertension	4.7%	8.1%	3.9%	5.4%	2.9%
Cystitis	3.7%	6.8%	3.9%	2.4%	2.7%
Oedema peripheral	2.2%	0%	6.6%	1.2%	1.2%
Cough	4.9%	5.4%	5.3%	6%	3.5%
Pain in extremity	4.3%	4.1%	2.6%	6%	3.1%
Gastroenteritis	2.6%	5.4%	3.9%	5.4%	3.5%
Abdominal pain	2%	5.4%	1.3%	2.4%	2.2%
Pharyngitis	4.1%	2.7%	2.6%	3%	5.1%

Secondary outcomes

What else it measured

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3ratio · Year 3 in Period II · least squares mean

Exen + Metn=148	Glim + Metn=166
66.86(4.045)	68.52(3.813)

Change in HOMA-B From Baseline to Endpointratio · Baseline, end of Period II (up to 4.5 years) · least squares mean

Exen + Metn=326	Glim + Metn=329
5.56(6.147)	19.92(6.340)

Fasting Proinsulin/Insulin Ratio at Year 3ratio · Year 3 in Period II · least squares mean

Exen + Metn=152	Glim + Metn=170
0.22(0.023)	0.23(0.022)

Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.ratio · Baseline, end of Period II (up to 4.5 years) · least squares mean

Exen + Metn=326	Glim + Metn=331
0.03(0.014)	0.05(0.015)

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 3ratio · Year 3 in Period II · least squares mean

Exen + Metn=130	Glim + Metn=156
25.81(3.323)	26.38(3.032)

Change in DI30/DG30 Ratio From Baseline to Endpointratio · Baseline, end of Period II (up to 4.5 years) · least squares mean

Exen + Metn=302	Glim + Metn=311
12.10(4.115)	0.91(4.299)

Disposition Index at Year 3ratio · Year 3 in Period II · least squares mean

Exen + Metn=130	Glim + Metn=156
12.56(1.179)	7.89(1.078)

Change in Disposition Index From Baseline to Endpointratio · Baseline, end of Period II (up to 4.5 years) · least squares mean

Exen + Metn=302	Glim + Metn=311
9.15(1.764)	1.82(1.849)

Change in HbA1c From Baseline to Year 3percentage of total hemoglobin · Baseline, Year 3 in Period II · least squares mean

Exen + Metn=182	Glim + Metn=197
-0.30(0.051)	-0.12(0.049)

Change in HbA1c From Baseline to Endpointpercentage of total hemoglobin · Baseline, end of Period II (up to 4.5 years) · least squares mean

Exen + Metn=488	Glim + Metn=485
-0.36(0.035)	-0.21(0.035)

Fasting Plasma Glucose at Year 3mmol/L · Year 3 in Period II · least squares mean

Exen + Metn=149	Glim + Metn=166
7.27(0.127)	7.96(0.120)

Change in Fasting Plasma Glucose From Baseline to Endpointmmol/L · Baseline, end of Period II (up to 4.5 years) · least squares mean

Exen + Metn=327	Glim + Metn=329
-0.87(0.155)	-0.41(0.161)

The trial

How NCT00359762 was run

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.

Exenatide
Glimepiride

Who could join the trial

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

Published papers

Papers from NCT00359762

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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