A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of exenatide once weekly in Japanese Patients with Type 2 Diabetes

Study identifier:H8O-JE-GWBW

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Type 2 Diabetes

Phase

Phase 1

Healthy volunteers

Study drug

exenatide once weekly, placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 75 Years

Date

Study Start Date: 01 Sept 2007

Primary Completion Date: 01 May 2008

Study Completion Date: 01 May 2008

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Experimental: 1 exenatide once weekly, 0.8mg	Drug: exenatide once weekly subcutaneous injection, once weekly
Experimental: 2 exenatide once weekly, 2.0mg	Drug: exenatide once weekly subcutaneous injection, once weekly
Placebo Comparator: 3 volume equivalent to 0.8mg of exenatide once weekly	Drug: placebo subcutaneous injection, once weekly
Placebo Comparator: 4 volume equivalent to 2.0mg of exenatide once weekly	Drug: placebo subcutaneous injection, once weekly

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center Support Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Chief Medical Officer