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Trial · Interventional

CompletedPhase 2Registry data

A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

NCTNCT00382239 (opens ClinicalTrials.gov in a new tab)Other idH8O-JE-GWAV
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
153 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
Sept 2006
Primary completion
May 2007
Completion
May 2007
First posted
28 Sept 2006 (estimated)
Last update posted
23 Feb 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 2

    A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

    NCT00382239

    Sept 2006 to May 2007

Registry summary

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

This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.

Interventions

  • exenatide (LY2148568)Drug
  • exenatide (LY2148568)Drug
  • exenatide (LY2148568)Drug
  • PlaceboDrug

Arms4

  • Experimental

    Exenatide 5 mcg/exenatide 10 mcg

  • Experimental

    Exenatide 5 mcg/exenatide 5 mcg

  • Experimental

    Exenatide 2.5 mcg/exenatide 2.5 mcg

  • Placebo comparator

    Placebo/placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12

    Time frame · Baseline, Week 12

    Registry description

    Assess dose response effect on glucose control as measured by HbA1c among four doses (2.5 μg, 5 μg, 10 μg, and placebo) of subcutaneous injection of exenatide, twice daily before meals in the morning and evening, for 12 weeks

Secondary outcomes(4)

  1. Proportion of subjects achieving HbA1c <7% at Week 12

    Time frame · 12 weeks

    Registry description

    Total number of subjects achieving HbA1c \<7% at Week 12

  2. Changes in fasting blood glucose from Visits 3 to 7

    Time frame · Baseline, Week 12

    Registry description

    Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)

  3. Change in Serum lipids from Baseline to Week 12

    Time frame · Baseline, Week 12

    Registry description

    Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7)

  4. Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12

    Time frame · Baseline, Week 12

    Registry description

    Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7)

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2012

15 results

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.

Fineman et al. 2012Diabetes, obesity & metabolismcited by 117

PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356

Full text at the publisher15 results
Publisher pageSee results (15)

Indexing hint: Randomized controlled trial · 2009

15 results

Exenatide exhibits dose-dependent effects on glycemic control over 12 weeks in Japanese patients with suboptimally controlled type 2 diabetes.

Kadowaki et al. 2009Endocrine journalcited by 41

PMID 19194050DOI 10.1507/endocrj.k08e-296PUB-19194050

Rights unknown15 results
Source linkSee results (15)

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: * Diagnosed with type 2 diabetes. * Have a body weight of \>=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 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). * Have characteristics contraindicating for concomitant medication, according to product-specific label. * Have severe allergy or hypersensitivity to any drug.

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