Phase 3 N=181 Randomized Double-blind Treatment

Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00577824 ↗

Enrolled (actual)

181

Serious AEs

3.4%

Results posted

Dec 2009

Primary outcome: Primary: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 — -1.34; -1.62; -0.28 Percentage of hemoglobin — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: exenatide (Drug); placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24	-1.34; -1.62; -0.28	<0.001 sig
SECONDARY Percentage of Patients Achieving HbA1c < 7.0%	67.1; 71.0; 15.2	<0.001 sig
SECONDARY Percentage of Patients Achieving HbA1c < 6.5%	36.6; 47.2; 8.6	<0.001 sig
SECONDARY Change in Fasting Blood Glucose	-25.1; -29.0; -7.6	<0.002 sig
SECONDARY Change in Body Weight	-0.39; -1.54; -0.47	0.026 sig
SECONDARY Change in Total Cholesterol	-14.45; -7.01; -4.80	0.672
SECONDARY Change in Low Density Lipoprotein Cholesterol (LDL-C)	-8.89; -5.03; -2.66	0.580
SECONDARY Change in High Density Lipoprotein Cholesterol (HDL-C)	-4.63; -4.22; -0.97	0.014 sig
SECONDARY Change in Triglycerides	4.00; 4.13; -4.60	0.490
SECONDARY Change in Waist Size	-0.17; -1.81; 0.41	0.003 sig
SECONDARY Change in Waist-to-hip Ratio	0.0016; -0.0108; -0.0007	0.208
SECONDARY 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24	169; 175; 170; 150; 140; 167	—
SECONDARY Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)	2.475; 6.836; -0.707	0.708
SECONDARY Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)	-0.541; -0.366; -0.375	0.974
SECONDARY Change in Serum Insulin	-0.2; 0.2; -0.7	—
SECONDARY Change in C-peptide	0.05; 0.07; -0.08	0.200
SECONDARY Change in 1,5-anhydroglucitol	5.29; 4.52; 0.66	<0.001 sig

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00577824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.