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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

Overview

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

Croatia, Germany, Greece, Italy, Netherlands, Portugal, Romania, Russia, Slovenia, Spain, Taiwan, United Kingdom

Start
Nov 2003
Primary completion
Jul 2008
Completion
Jul 2008
First posted
10 May 2004 (estimated)
Last update posted
7 Apr 2015 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2003200420052006200720082009
  1. Ph 3

    Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

    NCT00082407

    Nov 2003 to Jul 2008

Registry summary

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

This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).

Interventions

  • exenatideDrug
  • biphasic insulin aspartDrug

Arms2

  • Experimental

    Exenatide Arm

    subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks

  • Active comparator

    Biphasic Insulin Aspart Arm

    subcutaneous injection, twice daily; titration to target blood glucose level

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glcosylated Hemoglobin (HbA1c)

    Time frame · baseline, week 52

    Registry description

    Change in HbA1c from baseline to week 52

Secondary outcomes(6)
  1. Percentage of Patients Achieving HbA1c <=7%

    Time frame · 52 weeks

    Registry description

    Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 52 (percentage = \[number of subjects with HbA1c \<=7% at week 52 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).

  2. Change in Body Weight

    Time frame · baseline, week 52

    Registry description

    Change in body weight from baseline to week 52.

  3. Change in Fasting Serum Glucose

    Time frame · baseline, week 52

    Registry description

    Change in fasting serum glucose from baseline to week 52

  4. Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

    Time frame · baseline, week 52

    Registry description

    Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52

  5. Percentage of Patients With Hypoglycemic Events

    Time frame · 52 weeks

    Registry description

    Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study

  6. Change in Rate of Hypoglycemic Events

    Time frame · baseline, week 52

    Registry description

    Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52

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 52

Change in Glcosylated Hemoglobin (HbA1c)

GroupValue (percentage)Spread
Exenatide Arm8.590.07
Biphasic Insulin Aspart Arm8.650.07
Secondary and other outcome results(6)
Secondary outcomeNumber· 52 weeks

Percentage of Patients Achieving HbA1c <=7%

GroupValue (percentage of participants)
Exenatide Arm31.7
Biphasic Insulin Aspart Arm24.1
Secondary outcomeLeast squares mean· baseline, week 52

Change in Body Weight

GroupValue (kg)Spread
Exenatide Arm85.510.99
Biphasic Insulin Aspart Arm83.380.99
Secondary outcomeLeast squares mean· baseline, week 52

Change in Fasting Serum Glucose

GroupValue (mmol/L)Spread
Exenatide Arm11.000.18
Biphasic Insulin Aspart Arm11.300.18
Secondary outcomeMean· baseline, week 52

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

GroupValue (mmol/L)Spread
Exenatide Arm9.572.34
Biphasic Insulin Aspart Arm9.862.65
Secondary outcomeNumber· 52 weeks

Percentage of Patients With Hypoglycemic Events

GroupValue (percentage of participants)
Exenatide Arm53.0
Biphasic Insulin Aspart Arm51.6
Secondary outcomeLeast squares mean· baseline, week 52

Change in Rate of Hypoglycemic Events

GroupValue (events per 30 days per patient)Spread
Exenatide Arm0.220.07
Biphasic Insulin Aspart Arm0.180.07

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Armsubcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks–19 / ?179 / ?
Biphasic Insulin Aspart Armsubcutaneous injection, twice daily; titration to target blood glucose level–11 / ?128 / ?

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

3 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

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

Indexing hint: Randomized controlled trial · 2007

9 results

A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study.

Nauck et al. 2007Diabetologiacited by 312

PMID 17160407DOI 10.1007/s00125-006-0510-2PUB-17160407

Rights unknown9 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients have been treated with a stable dose of the following for at least 3 months prior to screening: 1. \>=1500 mg/day immediate-release metformin or extended-release metformin and at least an optimally effective dose for brand of sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components * HbA1c between 7.0% and 11.0%, inclusive. * Patients have a body mass index \>25kg/m2 and \<40 kg/m2. * Female patients are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control Exclusion Criteria: * Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. * Patients are employed by Lilly or Amylin. * Patients have previously, in this or any other study, received exenatide or glucagon-like peptide-1 analogs. * Patients have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. * Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening. * Patients have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer). * Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. * Patients have a known allergy or hypersensitivity to biphasic insulin aspart, exenatide, or excipients contained in these agents. * Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label. * Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine \>=1.5 mg/dL for males and \>=1.2 mg/dL for females. * Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase greater than three times the upper limit of the reference range. * Patients have known hemoglobinopathy or chronic anemia. * Patients have active proliferative retinopathy or macular edema. * Patients are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility, including but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics. * Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. * Patients have used any prescription drug to promote weight loss within 3 months prior to screening. * Patients have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides. * Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator. * Patients fail to satisfy the investigator of suitability to participate for any other reason.

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