Phase 3 · Exenatide

NCT00676338 trial results

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

Change in HbA1c From Baseline to Week 26 (percentage of total hemoglobin), Baseline, Week 26. Exenatide Once Weekly: -1.53; Metformin: -1.48; Pioglitazone: -1.63; Sitagliptin: -1.15.

Participants
820
Status
completed
Completed
2011-01
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00676338), updated at source Apr 9, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00676338 measured first

Change in HbA1c From Baseline to Week 26percentage of total hemoglobin · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=218Metforminn=218Pioglitazonen=137Sitagliptinn=142
-1.53(0.07)-1.48(0.07)-1.63(0.08)-1.15(0.08)
Percentage of Patients Achieving HbA1c <=7% at Week 26percentage of patients · Baseline, Week 26 · number
Exenatide Once Weeklyn=226Metforminn=232Pioglitazonen=150Sitagliptinn=143
64.257.363.345.5
Side effects by arm

Side effects in NCT00676338

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

EventExenatide Once WeeklyMetforminPioglitazoneSitagliptin
Any serious event1.6%4.9%5.5%1.8%
Diarrhoea10.9%12.6%3.7%5.5%
Headache8.1%12.2%8%9.2%
Nausea11.3%6.9%3.7%3.7%
Injection site nodule10.5%10.2%3.7%6.7%
Nasopharyngitis7.7%4.5%8.6%9.8%
Constipation8.5%3.3%1.8%2.5%
Hypertension1.2%1.2%7.4%1.8%
Oedema peripheral0%0.4%7.4%0.6%
Dyspepsia7.3%3.3%4.9%1.8%
Back pain2.4%5.7%4.3%3.1%
Arthralgia5.2%1.2%3.1%1.8%
Secondary outcomes

What else it measured

Change in Fasting Serum Glucose (FSG) From Baseline to Week 26mmol/L · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=198Metforminn=203Pioglitazonen=127Sitagliptinn=120
-2.25(0.14)-1.98(0.14)-2.57(0.18)-1.13(0.18)
Change in Body Weight From Baseline to Week 26kg · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=215Metforminn=217Pioglitazonen=134Sitagliptinn=141
-2.04(0.21)-2.00(0.21)1.52(0.26)-0.76(0.26)
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26mmol/L · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=199Metforminn=203Pioglitazonen=127Sitagliptinn=120
-0.24(0.06)-0.22(0.06)0.09(0.08)-0.01(0.08)
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26mmol/L · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=199Metforminn=203Pioglitazonen=127Sitagliptinn=120
0.01(0.01)0.07(0.01)0.17(0.02)0.04(0.02)
Ratio of Fasting Triglycerides at Week 26 to Baselineratio · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=200Metforminn=204Pioglitazonen=127Sitagliptinn=121
0.98(0.03)0.96(0.03)0.85(0.03)0.94(0.04)
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Eventsevents per subject-year · Baseline to Week 26 · mean
Exenatide Once Weeklyn=248Metforminn=246Pioglitazonen=163Sitagliptinn=163
0.00(0.000)0.00(0.000)0.00(0.000)0.00(0.000)
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Eventsevents per subject-year · Baseline to Week 26 · mean
Exenatide Once Weeklyn=248Metforminn=246Pioglitazonen=163Sitagliptinn=163
0.05(0.021)0.00(0.000)0.00(0.000)0.00(0.000)
Change in Systolic Blood Pressure From Baseline to Week 26.mmHg · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=215Metforminn=217Pioglitazonen=134Sitagliptinn=141
-1.25(0.79)0.14(0.78)-1.74(0.98)-1.81(0.96)
Change in Diastolic Blood Pressure From Baseline to Week 26.mmHg · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=215Metforminn=217Pioglitazonen=134Sitagliptinn=141
-0.50(0.51)-0.86(0.50)-2.50(0.63)-0.45(0.62)
The trial

How NCT00676338 was run

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

  • Exenatide Once Weekly
  • Metformin
  • Sitagliptin
  • Pioglitazone
Who could join the trial

Inclusion Criteria: * have type 2 diabetes and are treated with diet and exercise alone. * at least 18 years of age. * HbA1c between 7.1% and 11.0%, inclusive. * Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive. * Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening). Exclusion Criteria: * Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty * Have a history of renal transplantation or are currently receiving renal dialysis * Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years. * Have history of severe GI disorder (e.g., gastroparesis) * Have a history of acute or chronic pancreatitis. * Have active proliferative retinopathy. * Have been treated with drugs that promote weight loss (e.g., Xenical®\[orlistat\], Meridia® \[sibutramine\], Acomplia® \[rimonabant\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of screening. * Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening. * Have had an organ transplant. * Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly. * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * Are currently enrolled in any other clinical study.

Published papers

Papers from NCT00676338

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

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