Clinical trial NCT00577824: Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)
Official title: Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: diabetes
exenatide
LY2148568
Byetta
Lilly
Amylin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-12-20
Enrollment: 181
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: Percentage of Patients Achieving HbA1c < 7.0%
timeFrame: 24 weeks
measure: Percentage of Patients Achieving HbA1c < 6.5%
timeFrame: 24 weeks
measure: Change in Fasting Blood Glucose
timeFrame: baseline, week 24
measure: Change in Body Weight
timeFrame: baseline, week 24
measure: Change in Total Cholesterol
timeFrame: baseline, week 24
measure: Change in Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: baseline, week 24
measure: Change in High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: baseline, week 24
measure: Change in Triglycerides
timeFrame: baseline, week 24
measure: Change in Waist Size
timeFrame: baseline, week 24
measure: Change in Waist-to-hip Ratio
timeFrame: baseline, week 24
measure: 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24
timeFrame: baseline, week 24
measure: Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)
timeFrame: baseline, week 24
measure: Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)
timeFrame: baseline, week 24
measure: Change in Serum Insulin
timeFrame: baseline, week 24
measure: Change in C-peptide
timeFrame: baseline, week 24
measure: Change in 1,5-anhydroglucitol
timeFrame: baseline, week 24
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaragi
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Namba M, Imaoka T, Yamamura A, Goto W, Boardman MK, Sowa H. Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks. J Diabetes Investig. 2011 Jun 5;2(3):210-7. doi: 10.1111/j.2040-1124.2010.00084.x.
citation: Inagaki N, Ueki K, Yamamura A, Saito H, Imaoka T. Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes. J Diabetes Investig. 2011 Nov 30;2(6):448-56. doi: 10.1111/j.2040-1124.2011.00137.x.
citation: Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.