Phase 3 · Exenatide

NCT00877890 trial results

A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

Change in HbA1c From Baseline to Week 24 (percentage of total hemoglobin), Day 1, Week 24. Exenatide Once Weekly: -1.57; Exenatide Twice Daily: -0.90.

Participants: 254
Status: completed
Completed: 2010-01
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT00877890), 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 NCT00877890 measured first

Change in HbA1c From Baseline to Week 24percentage of total hemoglobin · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=126	Exenatide Twice Dailyn=116
-1.57(0.104)	-0.90(0.110)

Side effects by arm

Side effects in NCT00877890

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

Event	Exenatide Once Weekly	Exenatide Twice Daily
Any serious event	2.3%	4.1%
Nausea	14%	35%
Diarrhoea	9.3%	4.1%
Vomiting	4.7%	8.9%
Headache	4.7%	8.1%
Upper respiratory tract infection	7%	4.1%
Dizziness	2.3%	6.5%
Injection site erythema	5.4%	2.4%

Secondary outcomes

What else it measured

Percentage of Subjects Achieving HbA1c Target of <7%percentage of subjects · Week 24 · number

Exenatide Once Weeklyn=129	Exenatide Twice Dailyn=123
58.1	30.1

Percentage of Subjects Achieving HbA1c Target of <=6.5%percentage of subjects · Week 24 · number

Exenatide Once Weeklyn=129	Exenatide Twice Dailyn=123
41.1	16.3

Change in Fasting Plasma Glucose From Baseline to Week 24mg/dL · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=127	Exenatide Twice Dailyn=117
-25.1(4.32)	-4.6(4.50)

Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dLpercentage of subjects · Week 24 · number

Exenatide Once Weeklyn=129	Exenatide Twice Dailyn=123
50.4	30.9

Change in Body Weight From Baseline to Week 24kg · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=128	Exenatide Twice Dailyn=120
-2.33(0.369)	-1.37(0.386)

Change in Sitting Systolic Blood Pressure From Baseline to Week 24mmHg · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=128	Exenatide Twice Dailyn=120
-2.9(1.13)	-1.2(1.19)

Change in Sitting Diastolic Blood Pressure From Baseline to Week 24mmHg · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=128	Exenatide Twice Dailyn=120
0.2(0.74)	-0.1(0.78)

Change in Total Cholesterol From Baseline to Week 24mg/dL · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=119	Exenatide Twice Dailyn=104
-15.4(2.61)	0.6(2.79)

Change in High-density Lipoprotein (HDL) From Baseline to Week 24mg/dL · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=119	Exenatide Twice Dailyn=104
0.0(0.60)	1.3(0.64)

Ratio of Triglycerides at Week 24 to Baselineratio · Day 1, Week 24 · least squares mean

Exenatide Once Weeklyn=119	Exenatide Twice Dailyn=104
0.94(0.032)	0.99(0.036)

Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Eventsrate per subject-year · Day 1 to Week 24 · mean

Exenatide Once Weekly With SUn=40	Exenatide Twice Daily With SUn=34	Exenatide Once Weekly No SUn=89	Exenatide Twice Daily No SUn=89
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 Eventsrate per subject-year · Day 1 to Week 24 · mean

Exenatide Once Weekly With SUn=40	Exenatide Twice Daily With SUn=34	Exenatide Once Weekly No SUn=89	Exenatide Twice Daily No SUn=89
0.75(0.217)	0.31(0.153)	0.00(0.000)	0.00(0.000)

The trial

How NCT00877890 was run

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Who could join the trial

Inclusion Criteria: * Has been diagnosed with type 2 diabetes mellitus * Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening * Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening * Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening * Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening: * Hormone replacement therapy (female subjects) * Oral contraceptives (female subjects) * Antihypertensive agents * Lipid-lowering agents * Thyroid replacement therapy * Antidepressant agents * Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over the counter antiobesity agents Exclusion Criteria: * Has ever been exposed to exenatide (exenatide once weekly \[exenatide LAR\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog * Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening * Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications: * Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening * Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening * Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening * Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

Published papers

Papers from NCT00877890

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

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