Phase 3 · Exenatide

NCT00637273 trial results

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Change in HbA1c From Baseline to Week 26 (percentage of total hemoglobin), Day 1, Week 26. Exenatide Once Weekly: -1.55; Sitagliptin: -0.92; Pioglitazone: -1.23.

Participants: 514
Status: completed
Completed: 2009-07
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT00637273), 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 NCT00637273 measured first

Change in HbA1c From Baseline to Week 26percentage of total hemoglobin · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=159	Sitagliptinn=162	Pioglitazonen=160
-1.55(0.100)	-0.92(0.099)	-1.23(0.099)

Side effects by arm

Side effects in NCT00637273

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

Event	Exenatide Once Weekly	Sitagliptin	Pioglitazone
Any serious event	2.5%	3%	6.1%
Nausea	23.8%	9.6%	4.8%
Diarrhoea	18.1%	9.6%	7.3%
Vomiting	11.3%	2.4%	3%
Upper respiratory tract infection	3.8%	9%	10.3%
Headache	9.4%	9%	4.2%
Oedema peripheral	1.3%	3%	7.9%
Sinusitis	3.1%	1.2%	6.7%
Urinary tract infection	6.3%	5.4%	3.6%
Constipation	5.6%	1.8%	1.2%
Fatigue	5.6%	0%	3%
Injection site pruritus	5%	4.8%	1.2%

Secondary outcomes

What else it measured

Percentage of Subjects Achieving HbA1c Target of <7% at Week 26percentage of subjects · Week 26 · number

Exenatide Once Weeklyn=160	Sitagliptinn=166	Pioglitazonen=165
58.8	30.7	43.6

Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26percentage of subjects · Week 26 · number

Exenatide Once Weeklyn=160	Sitagliptinn=166	Pioglitazonen=165
38.8	15.7	26.7

Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26percentage of subjects · Week 26 · number

Exenatide Once Weeklyn=160	Sitagliptinn=166	Pioglitazonen=165
13.8	9.0	4.8

Change in Body Weight From Baseline to Week 26kg · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=160	Sitagliptinn=163	Pioglitazonen=165
-2.31(0.323)	-0.77(0.322)	2.79(0.320)

Change in Fasting Plasma Glucose From Baseline to Week 26mg/dL · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=155	Sitagliptinn=161	Pioglitazonen=158
-31.8(3.79)	-16.3(3.72)	-27.3(3.75)

Change in Systolic Blood Pressure From Baseline to Week 26mmHg · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=160	Sitagliptinn=163	Pioglitazonen=165
-3.6(0.97)	0.2(0.95)	-1.6(0.95)

Change in Diastolic Blood Pressure From Baseline to Week 26mmHg · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=160	Sitagliptinn=163	Pioglitazonen=165
-1.4(0.57)	-0.4(0.57)	-2.5(0.56)

Change in Fasting Total Cholesterol From Baseline to Week 26mg/dL · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=146	Sitagliptinn=147	Pioglitazonen=154
-0.6(2.51)	3.1(2.49)	6.2(2.46)

Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26mg/dL · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=146	Sitagliptinn=147	Pioglitazonen=154
2.0(0.61)	2.0(0.60)	6.2(0.59)

Ratio of Fasting Triglycerides at Week 26 to Baselineratio · Day 1, Week 26 · least squares mean

Exenatide Once Weeklyn=159	Sitagliptinn=161	Pioglitazonen=159
0.95(0.029)	0.95(0.028)	0.84(0.025)

Assessment on Event Rate of Treatment-emergent Hypoglycemic Eventsrate per subject-year · Day 1 to Week 26 · mean

Measure	Exenatide Once Weeklyn=160	Sitagliptinn=166	Pioglitazonen=165
Treatment-Emergent Major Hypoglycemia	0.00(0.000)	0.00(0.000)	0.00(0.00)
Treatment-Emergent Minor Hypoglycemia	0.03(0.021)	0.12(0.039)	0.01(0.014)

The trial

How NCT00637273 was run

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

Who could join the trial

Inclusion Criteria: * Has been diagnosed with type 2 diabetes mellitus * Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start * Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start * Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start * 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 study start: 1. Hormone replacement therapy (female subjects) 2. Oral contraceptives (female subjects) 3. Antihypertensive agents 4. Lipid-lowering agents 5. Thyroid replacement therapy 6. Antidepressant agents 7. 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 been previously exposed to exenatide once weekly * Has donated blood within 60 days of study start or is planning to donate blood during the study * Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications: 1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start 2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start 3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start 4. 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 5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin * Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start * Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use

Published papers

Papers from NCT00637273

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

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