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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

NCTNCT00917267 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWCK
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
691 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
5 countries

China, India, Japan, South Korea, Taiwan

Start
Jul 2009
Primary completion
Sept 2010
Completion
Apr 2011
First posted
10 Jun 2009 (estimated)
Last update posted
9 Apr 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 3

    A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

    NCT00917267

    Jul 2009 to Apr 2011

Registry summary

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

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

Interventions

  • exenatide once weeklyDrug
  • exenatide twice dailyDrug

Arms2

  • Experimental

    1

  • Active comparator

    2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c From Baseline to Week 26.

    Time frame · Baseline, Week 26

    Registry description

    Change in HbA1c from baseline to Week 26.

Secondary outcomes(9)

  1. Percentage of Patients Achieving HbA1c Targets <=7% at Week 26

    Time frame · Baseline, Week 26

    Registry description

    Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with HbA1c \>7% at baseline).

  2. Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26

    Time frame · Baseline, Week 26

    Registry description

    Percentage of patients achieving HbA1c \<=6.5% at Week 26 (for patients with HbA1c \>6.5% at baseline).

  3. Change in Fasting Serum Glucose (FSG) From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

    Change in FSG from baseline to Week 26.

  4. Change in Body Weight (BW) From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

    Change in BW from baseline to Week 26.

  5. Change in Total Cholesterol (TC) From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

    Change in TC from baseline to Week 26.

  6. Change in High-Density Lipoprotein (HDL) From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

    Change in HDL from baseline to Week 26.

  7. Ratio of Triglycerides (TG) at Week 26 to Baseline

    Time frame · Baseline, Week 26

    Registry description

    Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.

  8. Change in Blood Pressure From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

    Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.

  9. Assessment of Event Rate of Treatment-emergent Hypoglycemic Events

    Time frame · Baseline to Week 26

    Registry description

    Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.

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, Week 26

Change in HbA1c From Baseline to Week 26.

GroupValue (percentage of total hemoglobin)Spread
Exenatide Once Weekly-1.430.07
Exenatide Twice Daily-1.120.07
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline, Week 26

Percentage of Patients Achieving HbA1c Targets <=7% at Week 26

GroupValue (percentage of patients)
Exenatide Once Weekly46.7
Exenatide Twice Daily35.7
Secondary outcomeNumber· Baseline, Week 26

Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26

GroupValue (percentage of patients)
Exenatide Once Weekly26.0
Exenatide Twice Daily15.5
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in Fasting Serum Glucose (FSG) From Baseline to Week 26

GroupValue (mg/dL)Spread
Exenatide Once Weekly-40.572.36
Exenatide Twice Daily-23.902.45
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in Body Weight (BW) From Baseline to Week 26

GroupValue (kg)Spread
Exenatide Once Weekly-1.630.16
Exenatide Twice Daily-2.450.16
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in Total Cholesterol (TC) From Baseline to Week 26

GroupValue (mg/dL)Spread
Exenatide Once Weekly-9.411.96
Exenatide Twice Daily-8.102.04
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in High-Density Lipoprotein (HDL) From Baseline to Week 26

GroupValue (mg/dL)Spread
Exenatide Once Weekly-0.110.41
Exenatide Twice Daily-0.480.43
Secondary outcomeLeast squares mean· Baseline, Week 26

Ratio of Triglycerides (TG) at Week 26 to Baseline

GroupValue (ratio)Spread
Exenatide Once Weekly0.970.02
Exenatide Twice Daily0.970.03

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Once WeeklySubcutaneous injection of 2 mg exenatide, once a week–13 / 340131 / 340
Exenatide Twice DailySubcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)–8 / 338150 / 338

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2013

14 results

Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus.

Ji et al. 2013Journal of diabetes investigationcited by 63

PMID 24843631PMC4019288DOI 10.1111/j.2040-1124.2012.00238.xPUB-24843631

Rights unknown14 results
Source linkSee results (14)

More studies

1 study on this page

PubMed tag: none · 2013

Safety of exenatide once weekly for 52 weeks in Japanese patients with type 2 diabetes mellitus.

Onishi et al. 2013Journal of diabetes investigationcited by 11

PMID 24843650PMC4019273DOI 10.1111/jdi.12000PUB-24843650

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have been diagnosed with type 2 diabetes. * Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive. * Have a body mass index (BMI) of \>21 kg/m2 and \<35 kg/m2, inclusive. * Have a history of stable body weight (not varying by \>5% for at least 90 days prior to study start). * Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start. Exclusion Criteria: * Have any contraindication for the OAD(s) that they use. * Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents. * Have received chronic \>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption. * Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start. * Have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start: * Insulin * Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin) * Pramlintide acetate * Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics. * Have had prior exposure to exenatide * Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW. * 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. * Are currently enrolled in any other clinical study.

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