Phase 3 · Exenatide

NCT00577824 trial results

Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 (Percentage of hemoglobin), baseline, 24 weeks. 5mcg Exenatide BID: -1.34; 10mcg Exenatide BID: -1.62; Placebo BID: -0.28.

Participants: 181
Status: completed
Completed: 2008-11
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT00577824), 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 NCT00577824 measured first

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24Percentage of hemoglobin · baseline, 24 weeks · least squares mean

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
-1.34(0.11)	-1.62(0.11)	-0.28(0.15)

Side effects by arm

Side effects in NCT00577824

Percent of participants affected, Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).. The most common events the registry lists.

Event	5mcg Exenatide BID	10mcg Exenatide BID	Placebo BID
Any serious event	2.8%	0%	11.4%
Hypoglycemia	51.4%	58.3%	22.9%
Nausea	25%	36.1%	8.6%
Blood glucose decreased	13.9%	25%	11.4%
Nasopharyngitis	11.1%	12.5%	22.9%
Vomiting	4.2%	16.7%	2.9%
Constipation	13.9%	15.3%	2.9%
Stomach discomfort	9.7%	12.5%	2.9%
Decreased appetite	9.7%	12.5%	2.9%
Anorexia	2.8%	11.1%	2.9%
Diarrhoea	11.1%	5.6%	5.7%
Dyspepsia	4.2%	6.9%	0%
Malaise	2.8%	5.6%	5.7%
Blood creatinine phosphokinase increased	0%	4.2%	5.7%
Abdominal pain upper	4.2%	2.8%	5.7%
Bronchitis	1.4%	2.8%	5.7%
Feeling abnormal	0%	5.6%	0%
Eczema	5.6%	2.8%	0%
Headache	5.6%	2.8%	2.9%

Secondary outcomes

What else it measured

Percentage of Patients Achieving HbA1c < 7.0%percentage of participants · 24 weeks · number

5mcg Exenatide BIDn=70	10mcg Exenatide BIDn=69	Placebo BIDn=33
67.1	71.0	15.2

Percentage of Patients Achieving HbA1c < 6.5%percentage of participants · 24 weeks · number

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
36.6	47.2	8.6

Change in Fasting Blood Glucosemg/dL · baseline, week 24 · least squares mean

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
-25.1(3.83)	-29.0(3.81)	-7.6(5.46)

Change in Body Weightkg · baseline, week 24 · least squares mean

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
-0.39(0.28)	-1.54(0.27)	-0.47(0.39)

Change in Total Cholesterolmg/dL · baseline, week 24 · mean

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
-14.45(3.36)	-7.01(3.13)	-4.80(3.76)

Change in Low Density Lipoprotein Cholesterol (LDL-C)mg/dL · baseline, week 24 · mean

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
-8.89(3.01)	-5.03(2.45)	-2.66(3.50)

Change in High Density Lipoprotein Cholesterol (HDL-C)mg/dL · baseline, week 24 · mean

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
-4.63(0.91)	-4.22(0.70)	-0.97(1.20)

Change in Triglyceridesmg/dL · baseline, week 24 · mean

5mcg Exenatide BIDn=71	10mcg Exenatide BIDn=72	Placebo BIDn=35
4.00(15.59)	4.13(8.03)	-4.60(7.25)

Change in Waist Sizecm · baseline, week 24 · mean

5mcg Exenatide BIDn=70	10mcg Exenatide BIDn=71	Placebo BIDn=35
-0.17(0.36)	-1.81(0.46)	0.41(0.45)

Change in Waist-to-hip Ratioratio (cm/cm) · baseline, week 24 · mean

5mcg Exenatide BIDn=70	10mcg Exenatide BIDn=71	Placebo BIDn=35
0.0016(0.0047)	-0.0108(0.0047)	-0.0007(0.0061)

7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24mg/dL · baseline, week 24 · mean

Measure	5mcg Exenatide BIDn=72	10mcg Exenatide BIDn=71	Placebo BIDn=35
30 minutes prior to breakfast SMBG at week 0	169(36.3)	175(40.9)	170(38.6)
30 minutes prior to breakfast SMBG at week 24	150(36.4)	140(32.2)	167(37.9)
2hr post-breakfast SMBG at week 0	261(50.5)	263(55.1)	254(65.1)
2hr post-breakfast SMBG at week 24	178(61.1)	149(54.4)	257(74.5)
30 minutes prior to lunch SMBG at week 0	179(48.4)	189(68.4)	179(49.2)
30 minutes prior to lunch SMBG at week 24	155(43.9)	152(41.3)	182(57.0)
2hr post-lunch SMBG at week 0	263(62.7)	268(62.4)	264(51.7)
2hr post-lunch SMBG at week 24	213(63.2)	195(60.7)	254(73.5)
30 minutes prior to dinner SMBG at week 0	166(53.7)	176(51.4)	173(42.5)
30 minutes prior to dinner SMBG at week 24	149(45.1)	140(35.5)	181(57.0)
2hr post-dinner SMBG at week 0	246(53.4)	247(63.6)	239(49.1)
2hr post-dinner SMBG at week 24	160(62.8)	141(57.7)	247(78.6)

Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)ratio · baseline, week 24 · mean

5mcg Exenatide BIDn=70	10mcg Exenatide BIDn=72	Placebo BIDn=35
2.475(10.566)	6.836(13.858)	-0.707(3.436)

The trial

How NCT00577824 was run

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Who could join the trial

Inclusion Criteria: * Diagnosed with type 2 diabetes. * Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start. * Have HbA1c 7.0% to 10% at study start. * Have a body weight \>=50 kg. Exclusion Criteria: * 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. * Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days. * Have been treated with any exogenous insulin within 90 days before study start. * Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start. * The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Published papers

Papers from NCT00577824

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

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