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Type 2 Diabetes MellitusPhase 3NCT01003184

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

A Phase 3 study testing exenatide once weekly and insulin detemir in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 34 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
exenatide once weekly and insulin detemir
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
34 sitesin 2 countries
Study dates
Oct 2009to Dec 2011
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
  • Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
  • Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start

Who cannot join

  • Have any contraindication for the OAD that they have been using
  • Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
  • Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
  • Have been treated with drugs that promote weight loss, within 3 months of screening
  • Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
  • Have previously completed or withdrawn from this study or any other study investigating exenatide 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, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United Kingdom33 sites

  • Research Site

    Aberdeen, Scotland

  • Research Site

    Addlestone, England

  • Research Site

    Bath, England

  • Research Site

    Birmingham, England

  • Research Site

    Blackburn, England

  • Research Site

    Bournemouth, England

  • Research Site

    Carmathen, Wales

  • Research Site

    Chippenham, England

  • Research Site

    Derby, England

  • Research Site

    Dundee, Scotland

  • Research Site

    Exeter, England

  • Research Site

    High Wycombe, England

  • Research Site

    Hull, England

  • Research Site

    Leicester, England

  • Research Site

    Leytonstone

  • Research Site

    Liverpool, England

  • Research Site

    Livingston

  • Research Site

    London, England

  • Research Site

    Manchester, England

  • Research Site

    Merseyside, England

  • Research Site

    Middlesbrough, England

  • Research Site

    Newcastle, England

  • Research Site

    Northampton, England

  • Research Site

    Oldham, England

  • Research Site

    Plymouth, England

  • Research Site

    Portsmouth, England

  • Research Site

    Sheffield, England

  • Research Site

    Stevenage, England

  • Research Site

    Suffolk, England

  • Research Site

    Swansea, Wales

  • Research Site

    Wakefield, England

  • Research Site

    Wiltshire, England

  • Research Site

    Wrexham, Wales

Other trials in United Kingdom

Ireland1 site

  • Research Site

    Dublin

Other trials in Ireland

About this study

Official title: Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea

The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.

Being tested
exenatide once weekly, insulin detemir
Keywords
diabetes, exenatide once weekly, Byetta, insulin detemir, Levemir, Amylin, Lilly
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.

  • exenatide once weeklyDrug

    subcutaneous injection, 2mg, once a week

  • insulin detemirDrug

    Also called Levemir

    subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day

Study groups in NCT01003184
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: exenatide once weekly
2Active comparatorNot described
Receives: Drug: insulin detemir

What is being measured

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

  1. Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

    The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.

    Measured: Baseline, Week 26

Secondary outcomes (13)

  1. Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

    Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)

    Measured: Baseline, Week 26

  2. Change in HbA1c From Baseline to Week 26

    Change in HbA1c from baseline to week 26

    Measured: Baseline, Week 26

  3. Change in Body Weight From Baseline to Week 26

    Change in body weight from baseline to week 26

    Measured: Baseline, Week 26

  4. Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint

    Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint

    Measured: Week 26

  5. Percentage of Patients Achieving ≤7.0% at Endpoint

    Percentage of patients achieving ≤7.0% at endpoint.

    Measured: Week 26

  6. Percentage of Patients Achieving ≤6.5% at Endpoint

    Percentage of patients achieving HbA1c ≤6.5% at endpoint

    Measured: Week 26

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

    Change in fasting serum glucose from baseline to endpoint (Week 26).

    Measured: Baseline, Week 26

  8. Changes in Systolic Blood Pressure From Baseline to Week 26

    Change in systolic blood pressure from baseline to Week 26

    Measured: Baseline, Week 26

  9. Change in Diastolic Blood Pressure From Baseline to Week 26.

    Change in diastolic blood pressure from baseline to week 26.

    Measured: Baseline, Week 26

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

    Change in total cholesterol from baseline to endpoint (week 26).

    Measured: Baseline, Week 26

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

    Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).

    Measured: Baseline, Week 26

  12. Change in Triglycerides From Baseline to Endpoint (Week 26).

    Change in triglycerides from baseline to endpoint (week 26).

    Measured: Baseline, Week 26

  13. Hypoglycemia Rate Per Year

    All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.

    Measured: Baseline, Week 26

Timeline

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

  1. First posted28 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJul 2011
  4. Study completionDec 2011

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
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01003184
Sponsor's protocol ID
H8O-EW-GWDL
Status last verified
Mar 2015
First submitted
15 Oct 2009
Last updated
7 Apr 2015
Data monitoring committee
No

Publications

  • Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.

    PubMed 32306296

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide once weekly and insulin detemir in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 34 sites in 2 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 3 inclusion and 8 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 34 sites in United Kingdom, Ireland. 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 18 Dec 2012). 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?

Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26) (time frame: Baseline, Week 26). 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 NCT01003184, which also lists 1 linked publication.

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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