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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

NCTNCT00935532 (opens ClinicalTrials.gov in a new tab)Other idH8O-JE-GWBX
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
427 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
Jul 2009
Primary completion
Sept 2010
Completion
Jul 2011
First posted
9 Jul 2009 (estimated)
Last update posted
15 Jun 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

    Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

    NCT00935532

    Jul 2009 to Jul 2011

Registry summary

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

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

Interventions

  • exenatide once weeklyDrug
  • insulin glargineDrug

Arms2

  • Experimental

    exenatide once weekly

  • Active comparator

    insulin glargine

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c From Baseline to Endpoint (Week 26)

    Time frame · Baseline, Week 26

    Registry description

    Change in HbA1c from baseline to endpoint (Week 26).

Secondary outcomes(10)

  1. Percentage of Subjects Achieving HbA1c<=7%

    Time frame · Baseline, Week 26

    Registry description

    Percentage of subjects achieving HbA1c \<=7.0% (for subjects with HbA1c \>7% at baseline)

  2. Percentage of Subjects Achieving HbA1c<=6.5%

    Time frame · Baseline, Week 26

    Registry description

    Percentage of subjects achieving HbA1c \<=6.5% (for subjects with HbA1c \>6.5% at baseline)

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

    Time frame · Baseline, Week 26

    Registry description

    Change in FSG (centralized measurement) from baseline to endpoint (Week 26)

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

    Time frame · Baseline, Week 26

    Registry description

    Change in Body Weight from baseline to endpoint (Week 26)

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

    Time frame · Baseline, Week 26

    Registry description

    Change in Total Cholesterol from baseline to endpoint (Week 26)

  6. Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)

    Time frame · Baseline, Week 26

    Registry description

    Change in HDL-C from baseline to endpoint (Week 26)

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

    Time frame · Baseline, Week 26

    Registry description

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

  8. Change in Blood Pressure From Baseline to Endpoint (Week 26)

    Time frame · Baseline, Week 26

    Registry description

    Change in Blood Pressure from baseline to endpoint (Week 26)

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

    Time frame · Baseline to Week 26

    Registry description

    Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

  10. Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events

    Time frame · Baseline to Week 26

    Registry description

    Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

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 Endpoint (Week 26)

GroupValue (percentage of total hemoglobin)Spread
Exenatide Once Weekly-1.110.06
Insulin Glargine-0.680.06
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline, Week 26

Percentage of Subjects Achieving HbA1c<=7%

GroupValue (percentage of subjects)
Exenatide Once Weekly42.2
Insulin Glargine21.0
Secondary outcomeNumber· Baseline, Week 26

Percentage of Subjects Achieving HbA1c<=6.5%

GroupValue (percentage of subjects)
Exenatide Once Weekly20.6
Insulin Glargine4.2
Secondary outcomeLeast squares mean· Baseline, Week 26

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

GroupValue (mg/dL)Spread
Exenatide Once Weekly-46.092.40
Insulin Glargine-40.822.39
Secondary outcomeLeast squares mean· Baseline, Week 26

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

GroupValue (kg)Spread
Exenatide Once Weekly-1.670.17
Insulin Glargine0.340.17
Secondary outcomeLeast squares mean· Baseline, Week 26

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

GroupValue (mg/dL)Spread
Exenatide Once Weekly-14.211.67
Insulin Glargine-6.321.67
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)

GroupValue (mg/dL)Spread
Exenatide Once Weekly-0.990.52
Insulin Glargine-0.710.51
Secondary outcomeLeast squares mean· Baseline, Week 26

Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline

GroupValue (ratio)Spread
Exenatide Once Weekly1.001.02
Insulin Glargine1.001.02

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Once WeeklySubcutaneous injection, 2.0mg, once a week.–6 / 215145 / 215
Insulin GlargineSubcutaneous injection, titrated to achieve fasting serum glucose target, once a day–5 / 21265 / 212

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

Indexing hint: Randomized controlled trial · 2012

6 results

Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study.

Inagaki et al. 2012Clinical therapeuticscited by 72

PMID 22884767DOI 10.1016/j.clinthera.2012.07.007PUB-22884767

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

PubMed tag: none · 2020

Corrected

Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.

Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6

PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296

Free to read · publisher termsCC BY-NC
Read at sourceRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * present with type 2 diabetes mellitus * HbA1c between 7.1% and 11.0% inclusive * body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive * treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start Exclusion Criteria: * Have received chronic (\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start. * Have been treated with drugs that promote weight loss within 90 days prior to study start. * Have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start. * Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered). * Have been treated for \>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs * Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication. * Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start. * Have donated blood within 30 days prior to study start.

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