A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Multiple-Dose Study to Examine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2148568 Long-Acting Release in Japanese Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612794
• Other study ID #: H8O-JE-GWBW
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2008
• Last updated: February 23, 2015
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. This study is designed to evaluate safety and tolerability of exenatide once weekly in Japanese patients and determine whether the dose selected for US and European development is appropriate for Japanese patients with Type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Body weight =50 kg.

• Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: *6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; *6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.

• Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® [acarbose], Basen® [voglibose], or Seibule® [miglitol]) or meglitinide derivatives (Glufast® [mitiglinide] or Fastic®/Starsis® [nateglinide]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.

Exclusion Criteria:

• Subjects who have donated more than 200 mL of blood and component blood donation within one month of study start, or those who have donated more than 400 mL of blood within three months of study start.

• 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 and received at least one dose of exenatide or other GLP-1 analogs in this study previously, or any other study using exenatide or other GLP-1 analogs.

• Are treated with any exogenous insulin within 3 months of screening.

• Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *Drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).

• Females who are breastfeeding.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics 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 once weekly
subcutaneous injection, once weekly
• placebo
subcutaneous injection, once weekly

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka
Japan	Research Site	Kanagawa
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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of exenatide administered once weekly by subcutaneous (SC) injection in subjects with type 2 diabetes mellitus.		10 weeks	Yes
Secondary	To assess the pharmacokinetics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus.		10 weeks	No
Secondary	To explore the pharmacodynamics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus regarding the following: *fasting and postprandial glucose concentrations; *HbA1c; *Body weight.		10 weeks	No