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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT00612794 (opens ClinicalTrials.gov in a new tab)Other idH8O-JE-GWBW
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
30 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
Sept 2007
Primary completion
May 2008
Completion
May 2008
First posted
12 Feb 2008 (estimated)
Last update posted
24 Feb 2015 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 1

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

    NCT00612794

    Sept 2007 to May 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatide once weeklyDrug
  • placeboDrug

Arms4

  • Experimental

    1

    exenatide once weekly, 0.8mg

  • Experimental

    2

    exenatide once weekly, 2.0mg

  • Placebo comparator

    3

    volume equivalent to 0.8mg of exenatide once weekly

  • Placebo comparator

    4

    volume equivalent to 2.0mg of exenatide once weekly

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 10 weeks

Secondary outcomes(2)

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

    Time frame · 10 weeks

  2. 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.

    Time frame · 10 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2009

13 results

Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes.

Iwamoto et al. 2009Endocrine journalcited by 36

PMID 19706990DOI 10.1507/endocrj.k09e-147PUB-19706990

Full text at the publisher13 results
Publisher pageSee results (13)

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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