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

NCT00612794 | Completed Phase 1

• 1 other identifier: H8O-JE-GWBW
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Type 2 Diabetes

Keywords

exenatide; Byetta; diabetes; Amylin; Lilly

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of exenatide administered once weekly by subcutaneous (SC) injection in subjects with type 2 diabetes mellitus.

  10 weeks

Secondary Outcomes (2)

• To assess the pharmacokinetics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus.

  10 weeks

• 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

Study Arms (4)

1

EXPERIMENTAL

exenatide once weekly, 0.8mg

Drug: exenatide once weekly

2

EXPERIMENTAL

exenatide once weekly, 2.0mg

Drug: exenatide once weekly

3

PLACEBO COMPARATOR

volume equivalent to 0.8mg of exenatide once weekly

Drug: placebo

4

PLACEBO COMPARATOR

volume equivalent to 2.0mg of exenatide once weekly

Drug: placebo

Interventions

exenatide once weekly DRUG

subcutaneous injection, once weekly

1; 2

placebo DRUG

subcutaneous injection, once weekly

3; 4

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (4)

Research Site

Fukuoka, Japan

Location

Research Site

Kanagawa, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (1)

• Iwamoto K, Nasu R, Yamamura A, Kothare PA, Mace K, Wolka AM, Linnebjerg H. Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. Endocr J. 2009;56(8):951-62. doi: 10.1507/endocrj.k09e-147. Epub 2009 Aug 25.

  PMID: 19706990 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chief Medical Officer, MD

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 12, 2008
• Study Start: September 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 24, 2015

Record last verified: 2015-01

Locations

JP (4)