Phase 3 · Exenatide

NCT00753896 trial results

Safety of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Treated With Thiazolidinedione Alone or Thiazolidinedione in Combination With Metformin

Participants
134
Status
completed
Completed
2009-11
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00753896), updated at source Apr 21, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00753896 measured first

Percentage of Patients Experiencing Adverse Eventspercentage of patients · Baseline to Week 52 · number
Exenatide Once Weeklyn=134
73.1
Assessment of Event Rate of Treatment-Emergent Hypoglycemic Eventsevents per subject-year · Baseline to Week 52 · mean
MeasureExenatide Once Weeklyn=134
Major Hypoglycemia0.00(0.000)
Minor Hypoglycemia0.02(0.014)
Side effects by arm

Side effects in NCT00753896

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

EventExenatide Once Weekly
Any serious event6.7%
Nausea16.4%
Injection site nodule11.2%
Nasopharyngitis9.7%
Decreased appetite9%
Headache9%
Upper respiratory tract infection7.5%
Vomiting7.5%
Constipation6%
Dyspepsia6%
Arthralgia5.2%
Diarrhoea5.2%
Influenza5.2%
Secondary outcomes

What else it measured

Change in HbA1c From Baseline to Week 52percentage of total hemoglobin · Baseline, Week 52 · mean
Exenatide Once Weeklyn=132
-0.78(0.07)
Percentage of Patients Achieving HbA1c <=7% at Week 52percentage of patients · Baseline, Week 52 · number
Exenatide Once Weeklyn=64
68.8
Percentage of Patients Achieving HbA1c <=6.5% at Week 52percentage of patients · Baseline, Week 52 · number
Exenatide Once Weeklyn=96
54.2
Change in Fasting Serum Glucose From Baseline to Week 52mmol/L · Baseline, Week 52 · mean
Exenatide Once Weeklyn=126
-1.59(0.21)
Change in Body Weight From Baseline to Week 52kg · Baseline, Week 52 · mean
Exenatide Once Weeklyn=134
-1.50(0.45)
Change in Total Cholesterol From Baseline to Week 52mmol/L · Baseline, Week 52 · mean
Exenatide Once Weeklyn=126
-0.18(0.08)
Change in High-density Lipoprotein (HDL) From Baseline to Week 52mmol/L · Baseline, Week 52 · mean
Exenatide Once Weeklyn=126
0.04(0.02)
Change in Triglycerides From Baseline to Week 52mmol/L · Baseline, Week 52 · mean
Exenatide Once Weeklyn=126
-0.19(0.07)
Change in Blood Pressure From Baseline to Week 52mmHg · Baseline, Week 52 · mean
MeasureExenatide Once Weeklyn=134
Systolic Blood Pressure-1.69(1.12)
Diastolic Blood Pressure-0.19(0.70)
The trial

How NCT00753896 was run

This study will examine the safety of exenatide once weekly (2.0 mg) in approximately 134 patients receiving treatment with thiazolidinedione alone or thiazolidinedione in combination with metformin. Patients are expected to be treated with exenatide once weekly for at least 52 weeks.

  • 1
Who could join the trial

Inclusion Criteria: * Have type 2 diabetes * At least 18 years of age at screening. * Have HbA1c of 7.1% to 10.0%, inclusive, at screening. * Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. * Have been treated with a stable dose of TZD (≥4 mg/day rosiglitazone or ≥30 mg/day pioglitazone) for at least 120 days prior to Visit 1 OR Have been treated with a stable dose of TZD (≥4 mg/day rosiglitazone or ≥30 mg/day pioglitazone) for at least 120 days PLUS a stable dose of metformin for at least 90 days prior to Visit 1. * Have a history of stable body weight (not varying by \>10% for at least 3 months prior to screening). * If female of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only. * Are not breastfeeding. * Test negative for pregnancy at the time of screening based on a serum pregnancy test. * Intend not to become pregnant during the study. * Have practiced a reliable method of birth control (e.g., use of oral contraceptives or approved hormonal implant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for at least 6 weeks prior to screening. * Agree to continue to use a reliable method of birth control (see above) during the study. Exclusion Criteria: * Have had a clinically significant 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, coronary artery bypass surgery, angioplasty. * Is expected to require coronary artery bypass surgery or angioplasty during the course of the study. * Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis * Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine ≥135 μmol/L for males and ≥110 μmol/L for females. * 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 known hemoglobinopathy or chronic anemia (hemoglobin concentration \<11.5 g/dL \[115 g/L\] for males, \<10.5 g/dL \[105 g/L\] for females). * Have clinically significant history or presence of severe gastrointestinal disease, particularly those which may impact gastric emptying, such as gastroparesis, pyloric stenosis, or gastric bypass surgery. * Have a history of pancreatitis. * Have had greater than three episodes of major hypoglycemia within 6 months prior to screening. * Have any contraindication for the OAD(s) which they use, according to local label requirements. * Are known to have active proliferative retinopathy. * Are receiving chronic (\>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations)...

Published papers

Papers from NCT00753896

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

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