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Diabetes Mellitus, Type 2Phase 3NCT00082407

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

A Phase 3 study testing exenatide and biphasic insulin aspart in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 69 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
exenatide and biphasic insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
505 participants
Where
69 sitesin 12 countries
Study dates
Nov 2003to Jul 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 19Show fewer
  • 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.

Trial locations and contacts

69 sites in 12 countries.

69 sites in 12 countries

Germany13 sites

  • Internistische Gemeinschaftspraxis

    Augsburg, 86150

  • Dr. Karlheinz Hehemann

    Beckum, 59269

  • Dr. Klaus Busch

    Dortmund, 44137

  • Medical Clinic and Policlinic 3

    Giessen, 35392

  • Diabetologische Schwerpunktpraxis

    Hamburg, 21073

  • IKFE GmbH

    Mainz, 55119

  • Institut for diabetic research

    Munich, 80804

  • Profil, Institut fur Stoffwechselstorungen

    Neuss, 41460

  • Dr. Thomas Behnke

    Neuwied, 56564

  • Dr. Bernd Donaubauer

    Oschatz, 04758

  • Marienhospital Osnabruck

    Osnabrück, 49074

  • Dr. Joerg Steindorf

    Schkeuditz, 04435

  • Dr. Jerzi Jasinski

    Wiesbaden, 65183

Other trials in Germany

United Kingdom12 sites

  • Diabetes Research, Ward 34, Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Diabetes Unit, Blackburn Royal Infirmary

    Blackburn, BB2 3LR

  • Colchester General Hospital

    Colchester, CO4 5JL

  • Royal Infirmary of Edinburgh

    Edinburgh, EH3 9YW

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF

  • The Michael White Center for Diabetes and Endocrinology

    Hull, HU3 2JZ

  • Clinical Sciences Centre

    Liverpool, L7 8XP

  • Education Centre, James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Wellcome Labs, Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Queens Medical Centre

    Nottingham, NG7 2UH

  • Diabetes Trial Unit OCDEM, Churchill Hospital

    Oxford, OX3 7LJ

  • Diabetes Unit, Gladsone Centre, Maelor Hospital

    Wrexham, LL13 7TD

Other trials in United Kingdom

Russia7 sites

  • National Endocrinology Research Center

    Moscow, 117036

  • Setchenov Moscow Medical Academy

    Moscow, 119881

  • Moscow State Medical Stomatological

    Moscow, 123448

  • Russian Medical Academy for Advanced Medical Studies, Ministry of Health

    Moscow, 125315

  • Hospital of St. Elizabeth's

    Saint Petersburg, 193257

  • City Clinical Hospital #2

    Saint Petersburg, 194354

  • Medical Military Academy

    Saint Petersburg, 198013

Other trials in Russia

Italy6 sites

  • Instituto di Endocrinologia

    Catania, 95124

  • Dipartimento di fisiopatologia clinica

    Florence, 50134

  • U.O. Medicina Generale

    Milan, 60-20132

  • Ospedale Civile di Padova

    Padova, 35128

  • Policlinico Univarsitario P. Giaccone

    Palermo, 90127

  • U.O. Universita di Malattie del Metabolismo e Diabetologia

    Torino

Other trials in Italy

Spain6 sites

  • Hospital Vega Baja

    Alicante, 03300

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Endocrinology Service (Planta Baja)

    Palma de Mallorca, 07198

  • Hospital Virgen de Valme

    Seville, 41014

  • Hospital General de Teruel

    Teruel, 44002

  • Hospital la Ribera Alzira

    Valencia, 46600 Alzira

Other trials in Spain

Greece5 sites

  • "Polyclinic" General Hospital of Athens

    Athens, 10552

  • Department of Endocrinology

    Athens, 10676

  • Diabetes Center

    Athens, 11527

  • University Hospital of Patras

    Pátrai, 26500

  • 1st Internal Medicine Department "Papagergiou"

    Thessaloniki, 56429

Other trials in Greece

Croatia4 sites

  • Clinical Hospital Osijek

    Osijek, 31000

  • Klinica bolnica Dubrava

    Zagreb, 10000

  • Klinicki bolnicki centar Zagreb-Rebro

    Zagreb, 10000

  • Opca bolnica "Sveti Duh"

    Zagreb, 10000

Other trials in Croatia

Portugal4 sites

  • Hospitais da Universidade de Coimbra

    Coimbra, 3000-076

  • Hospital de Santo Andre

    Leiria, 2410-197

  • Associacao Protectora dos Diabeticos de Portugal

    Lisbon, 1250-203

  • Hospital Pedro Hispano

    Matosinhos Municipality, 4454-509

Other trials in Portugal

Taiwan4 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Tzu Chi General Hospital

    Hualien City

  • Veteran General Hospital-Taichung

    Taichung, 407

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

Netherlands3 sites

  • Gelre Ziekenhuizen

    Apeldoorn, 7300 DS

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • Maxima Medisch Centrum Location Eindhoven

    Eindhoven, 5631 BM

Other trials in Netherlands

Romania3 sites

  • Spitalul Judetean Brasov

    Brasov, 500326

  • Institutul de Diabet

    Bucharest, 020475

  • Spitalul Clinic nr. 1 Judetean

    Judet Timis, 300723

Other trials in Romania

Slovenia2 sites

  • Univerzitetni klinicni center Ljubljana

    Ljubljana, 1000

  • Splosna bolnisnica Maribor

    Maribor, 2000

Other trials in Slovenia

About this study

Official title: Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

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).

Being tested
exenatide, biphasic insulin aspart
Keywords
diabetes, exendin, Amylin, Lilly, insulin aspart
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exenatideDrug

    Also called Byetta

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

  • biphasic insulin aspartDrug

    Also called NovoLog

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

Study groups in NCT00082407
Study groupRoleWhat they receive
Exenatide ArmExperimentalsubcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
Receives: Drug: exenatide
Biphasic Insulin Aspart ArmActive comparatorsubcutaneous injection, twice daily; titration to target blood glucose level
Receives: Drug: biphasic insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glcosylated Hemoglobin (HbA1c)

    Change in HbA1c from baseline to week 52

    Measured: baseline, week 52

Secondary outcomes (6)

  1. Percentage of Patients Achieving HbA1c <=7%

    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%).

    Measured: 52 weeks

  2. Change in Body Weight

    Change in body weight from baseline to week 52.

    Measured: baseline, week 52

  3. Change in Fasting Serum Glucose

    Change in fasting serum glucose from baseline to week 52

    Measured: baseline, week 52

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

    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

    Measured: baseline, week 52

  5. Percentage of Patients With Hypoglycemic Events

    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

    Measured: 52 weeks

  6. Change in Rate of Hypoglycemic Events

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

    Measured: baseline, week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2004 (estimated)
  2. Study startNov 2003
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082407
Sponsor's protocol ID
H8O-MC-GWAD
Status last verified
Mar 2015
First submitted
6 May 2004
Last updated
7 Apr 2015
Data monitoring committee
No

Publications

  • Nauck MA, Duran S, Kim D, Johns D, Northrup J, Festa A, Brodows R, Trautmann M. 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. Diabetologia. 2007 Feb;50(2):259-67. doi: 10.1007/s00125-006-0510-2. Epub 2006 Dec 8.

    PubMed 17160407

  • Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.

    PubMed 22913891

  • Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

    PubMed 22236356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide and biphasic insulin aspart in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 69 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Germany, United Kingdom, Russia, Italy, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glcosylated Hemoglobin (HbA1c) (time frame: baseline, week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00082407, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

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