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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

NCTNCT00577824 (opens ClinicalTrials.gov in a new tab)Other idH8O-JE-GWBB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
181 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
Jan 2008
Primary completion
Nov 2008
Completion
Nov 2008
First posted
20 Dec 2007 (estimated)
Last update posted
9 Apr 2015 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph 3

    Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

    NCT00577824

    Jan 2008 to Nov 2008

Registry summary

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

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Interventions

  • exenatideDrug
  • exenatideDrug
  • placeboDrug

Arms3

  • Experimental

    1

  • Experimental

    2

  • Placebo comparator

    3

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

    Time frame · baseline, 24 weeks

    Registry description

    Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

Secondary outcomes(16)

  1. Percentage of Patients Achieving HbA1c < 7.0%

    Time frame · 24 weeks

    Registry description

    Percentage of subjects whose HbA1c was \>=7.0% at baseline who achieved an HbA1c \< 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 7.0% divided by total number of eligible subjects times 100)

  2. Percentage of Patients Achieving HbA1c < 6.5%

    Time frame · 24 weeks

    Registry description

    Percentage of subjects whose HbA1c was \>=6.5% at baseline who achieved an HbA1c \< 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 6.5% divided by total number of eligible subjects times 100)

  3. Change in Fasting Blood Glucose

    Time frame · baseline, week 24

    Registry description

    Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)

  4. Change in Body Weight

    Time frame · baseline, week 24

    Registry description

    Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)

  5. Change in Total Cholesterol

    Time frame · baseline, week 24

    Registry description

    Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

  6. Change in Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame · baseline, week 24

    Registry description

    Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)

  7. Change in High Density Lipoprotein Cholesterol (HDL-C)

    Time frame · baseline, week 24

    Registry description

    Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)

  8. Change in Triglycerides

    Time frame · baseline, week 24

    Registry description

    Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)

  9. Change in Waist Size

    Time frame · baseline, week 24

    Registry description

    Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)

  10. Change in Waist-to-hip Ratio

    Time frame · baseline, week 24

    Registry description

    Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.

  11. 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24

    Time frame · baseline, week 24

    Registry description

    Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).

  12. Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)

    Time frame · baseline, week 24

    Registry description

    Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.

  13. Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)

    Time frame · baseline, week 24

    Registry description

    Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.

  14. Change in Serum Insulin

    Time frame · baseline, week 24

    Registry description

    Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)

  15. Change in C-peptide

    Time frame · baseline, week 24

    Registry description

    Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)

  16. Change in 1,5-anhydroglucitol

    Time frame · baseline, week 24

    Registry description

    Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)

Posted results

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

Primary outcome results

Primary outcomeLeast squares mean· baseline, 24 weeks

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

GroupValue (Percentage of hemoglobin)Spread
5mcg Exenatide BID-1.340.11
10mcg Exenatide BID-1.620.11
Placebo BID-0.280.15
Secondary and other outcome results(7)
Secondary outcomeNumber· 24 weeks

Percentage of Patients Achieving HbA1c < 7.0%

GroupValue (percentage of participants)
5mcg Exenatide BID67.1
10mcg Exenatide BID71.0
Placebo BID15.2
Secondary outcomeNumber· 24 weeks

Percentage of Patients Achieving HbA1c < 6.5%

GroupValue (percentage of participants)
5mcg Exenatide BID36.6
10mcg Exenatide BID47.2
Placebo BID8.6
Secondary outcomeLeast squares mean· baseline, week 24

Change in Fasting Blood Glucose

GroupValue (mg/dL)Spread
5mcg Exenatide BID-25.13.83
10mcg Exenatide BID-29.03.81
Placebo BID-7.65.46
Secondary outcomeLeast squares mean· baseline, week 24

Change in Body Weight

GroupValue (kg)Spread
5mcg Exenatide BID-0.390.28
10mcg Exenatide BID-1.540.27
Placebo BID-0.470.39
Secondary outcomeMean· baseline, week 24

Change in Total Cholesterol

GroupValue (mg/dL)Spread
5mcg Exenatide BID-14.453.36
10mcg Exenatide BID-7.013.13
Placebo BID-4.803.76
Secondary outcomeMean· baseline, week 24

Change in Low Density Lipoprotein Cholesterol (LDL-C)

GroupValue (mg/dL)Spread
5mcg Exenatide BID-8.893.01
10mcg Exenatide BID-5.032.45
Placebo BID-2.663.50
Secondary outcomeMean· baseline, week 24

Change in High Density Lipoprotein Cholesterol (HDL-C)

GroupValue (mg/dL)Spread
5mcg Exenatide BID-4.630.91
10mcg Exenatide BID-4.220.70
Placebo BID-0.971.20

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
5mcg Exenatide BIDexenatide SC 5mcg, twice daily–2 / 7263 / 72
10mcg Exenatide BIDexenatide SC 10mcg, twice daily–0 / 7263 / 72
Placebo BIDplacebo SC, twice daily–4 / 3522 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2012

11 results

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.

Pencek et al. 2012Postgraduate medicinecited by 45

PMID 22913891DOI 10.3810/pgm.2012.07.2567PUB-22913891

Full text at the publisher11 results
Publisher pageSee results (11)

More studies

2 studies on this page

PubMed tag: none · 2011

Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks.

Kadowaki et al. 2011Journal of diabetes investigationcited by 45

PMID 24843486PMC4014921DOI 10.1111/j.2040-1124.2010.00084.xPUB-24843486

Rights unknown
Source link

PubMed tag: none · 2011

Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes.

Inagaki et al. 2011Journal of diabetes investigationcited by 13

PMID 24843529PMC4014904DOI 10.1111/j.2040-1124.2011.00137.xPUB-24843529

Rights unknown
Source link

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. * Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start. * Have HbA1c 7.0% to 10% at study start. * Have a body weight \>=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 glucagon-like peptide-1 (GLP-1) analogs within the last 90 days. * Have been treated with any exogenous insulin within 90 days before study start. * Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start. * The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

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