Phase 3 · Exenatide

NCT00360334 trial results

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) (percentage of participants), 26 weeks. Exenatide: 53.4; Insulin Glargine: 19.8.

Participants
235
Status
completed
Completed
2008-04
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00360334), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00360334 measured first

Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)percentage of participants · 26 weeks · number
Exenatiden=118Insulin Glarginen=116
53.419.8
Side effects by arm

Side effects in NCT00360334

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

EventExenatideInsulin Glargine
Nausea48.3%2.6%
Vomiting21.2%5.2%
Nasopharyngitis20.3%19.8%
Diarrhoea18.6%12.1%
Dyspepsia16.9%0%
Early satiety16.9%0%
Abdominal distension16.1%0.9%
Headache14.4%15.5%
Flatulence15.3%0.9%
Pain in extremity2.5%12.9%
Gastrooesophageal reflux disease11.9%0%
Cough3.4%11.2%
Eructation11%0%
Lower respiratory tract infection8.5%10.3%
Arthralgia4.2%10.3%
Abdominal Pain10.2%0%
Influenza6.8%9.5%
Anorexia9.3%0.9%
Pharyngolaryngeal pain4.2%8.6%
Dysgeusia8.5%0%
Back pain4.2%7.8%
Oedema peripheral0.8%6.9%
Bowel sounds abnormal5.9%0%
Pain1.7%5.2%
Rash5.1%3.4%
Secondary outcomes

What else it measured

Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kgPercentage of participants · 26 weeks · number
Exenatiden=118Insulin Glarginen=116
52.516.4
Change in Fasting Serum Glucosemmol/L · 26 weeks · least squares mean
Exenatiden=103Insulin Glarginen=101
-2.12(0.25)-3.61(0.25)
Percent of Patients Achieving HbA1c ≤ 7.4%Percentage of participants · 26 weeks · number
Exenatiden=118Insulin Glarginen=116
54.261.2
Percent of Patients Achieving HbA1c < 7%Percentage of participants · 26 weeks · number
Exenatiden=118Insulin Glarginen=116
34.743.1
Percent of Patients Achieving HbA1c < 6.5%Percentage of participants · 26 weeks · number
Exenatiden=118Insulin Glarginen=116
15.311.2
Change in 7 Point Self Monitored Blood Glucose Profilemmol/L · 26 weeks · mean
MeasureExenatiden=118Insulin Glarginen=116
Pre-breakfast: Baseline (Week 0)9.98(2.11)9.88(2.07)
Pre-breakfast: Change at endpoint (Week 26)-2.01(2.14)-3.99(2.39)
2 hrs after breakfast: Baseline (Week 0)13.53(3.07)13.33(2.87)
2 hrs after breakfast: Change at endpt (Week 26)-5.09(3.52)-3.95(3.89)
Pre-lunch: Baseline (Week 0)9.95(3.24)9.54(2.71)
Pre-lunch: Change at endpoint (Week 26)-2.21(3.11)-2.59(3.27)
2 hrs after lunch: Baseline (Week 0)12.07(3.27)11.15(2.59)
2 hrs after lunch: Change at endpoint (Week 26)-3.20(3.30)-2.48(3.17)
Pre-dinner: Baseline (Week 0)9.95(2.97)9.37(2.73)
Pre-dinner: Change at endpoint (Week 26)-2.13(2.89)-1.46(4.76)
2 hrs after dinner: Baseline (Week 0)12.59(3.28)11.80(2.62)
2 hrs after dinner: Change at endpoint (Week 26)-4.59(3.30)-2.06(3.22)
Change in Body Mass Index (BMI)kg/m^2 · 26 weeks · least squares mean
MeasureExenatiden=117Insulin Glarginen=114
Baseline (Week 0)34.49(0.49)33.71(0.49)
Change at endpoint (Week 26)-0.95(0.11)1.01(0.11)
Change in Waist Circumferencecm · 26 Weeks · least squares mean
MeasureExenatiden=117Insulin Glarginen=113
Baseline (Week 0)112.07(1.30)110.64(1.32)
Change at endpoint (Week 26)-2.19(0.54)1.97(0.54)
Change in Waist-to-hip RatioRatio · 26 weeks · least squares mean
MeasureExenatiden=117Insulin Glarginen=112
Baseline (Week 0)0.99(0.01)0.98(0.01)
Change at endpoint (Week 26)-0.02(0.00)0.01(0.00)
Change in Body Weightkg · 26 weeks · least squares mean
MeasureExenatiden=117Insulin Glarginen=113
Baseline (Week 0)101.19(1.68)97.93(1.70)
Change at endpoint (Week 26)-2.73(0.31)2.98(0.31)
Percent Change in Body WeightPercentage · 26 Weeks · least squares mean
Exenatiden=117Insulin Glarginen=113
-2.8(0.3)3.1(0.3)
Percent of Patients Achieving 5% Weight LossPercentage of participants · 26 weeks · number
Exenatiden=118Insulin Glarginen=116
19.50.9
The trial

How NCT00360334 was run

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

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Who could join the trial

Inclusion Criteria: * Diagnosed with type 2 diabetes * Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months. * HbA1c between 7.5% and 10.0%. * BMI \>27. Exclusion Criteria: * Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study. * Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study. * Treatment with the following medications: \*Insulin as outpatient therapy within last 3 months; \*Meglitinides, or acarbose within the last 3 months; \*Regular use of any drugs that directly affect gastrointestinal motility; \*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \*Anti-obesity agent use within the last 3 months. * 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.

Published papers

Papers from NCT00360334

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

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.