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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577824
• Other study ID #: H8O-JE-GWBB
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: March 20, 2015
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg, twice a day
• exenatide
subcutaneous injection, 10mcg, twice a day
• placebo
subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Locations

Country	Name	City	State
Japan	Research Site	Chiba
Japan	Research Site	Fukuoka
Japan	Research Site	Fukushima
Japan	Research Site	Hyogo
Japan	Research Site	Ibaragi
Japan	Research Site	Kanagawa
Japan	Research Site	Kumamoto
Japan	Research Site	Kyoto
Japan	Research Site	Nagano
Japan	Research Site	Oita
Japan	Research Site	Osaka
Japan	Research Site	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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 — View 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 we — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24	Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)	baseline, 24 weeks	No
Secondary	Percentage of Patients Achieving HbA1c < 7.0%	Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)	24 weeks	No
Secondary	Percentage of Patients Achieving HbA1c < 6.5%	Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)	24 weeks	No
Secondary	Change in Fasting Blood Glucose	Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)	baseline, week 24	No
Secondary	Change in Body Weight	Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)	baseline, week 24	No
Secondary	Change in Total Cholesterol	Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)	baseline, week 24	No
Secondary	Change in Low Density Lipoprotein Cholesterol (LDL-C)	Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)	baseline, week 24	No
Secondary	Change in High Density Lipoprotein Cholesterol (HDL-C)	Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)	baseline, week 24	No
Secondary	Change in Triglycerides	Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)	baseline, week 24	No
Secondary	Change in Waist Size	Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)	baseline, week 24	No
Secondary	Change in Waist-to-hip Ratio	Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.	baseline, week 24	No
Secondary	7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24	Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).	baseline, week 24	No
Secondary	Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)	Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.	baseline, week 24	No
Secondary	Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)	Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.	baseline, week 24	No
Secondary	Change in Serum Insulin	Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)	baseline, week 24	No
Secondary	Change in C-peptide	Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)	baseline, week 24	No
Secondary	Change in 1,5-anhydroglucitol	Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)	baseline, week 24	No

External Links

•   Lilly Clinical Trial Registry