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Type 2 DiabetesPhase 3NCT00360334

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

A Phase 3 study testing exenatide and insulin glargine in people with Type 2 Diabetes, run by AstraZeneca at 31 sites in United Kingdom.

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

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
exenatide and insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
31 sitesUnited Kingdom
Study dates
Jun 2006to Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with type 2 diabetes
  • Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
  • HbA1c between 7.5% and 10.0%.
  • BMI >27.

Who cannot join

  • Receive 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 study.
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
  • Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United Kingdom31 sites

  • Research Site

    Aberdeen

  • Research Site

    Bath

  • Research Site

    Blackburn

  • Research Site

    Bolton

  • Research Site

    Bournemouth

  • Research Site

    Bristol

  • Research Site

    Chippenham

  • Research Site

    Edinburgh

  • Research Site

    Glasgow

  • Research Site

    Haywards Heath

  • Research Site

    High Wycombe

  • Research Site

    Hull

  • Research Site

    Ipswich

  • Research Site

    Kent

  • Research Site

    Leicester

  • Research Site

    Liverpool

  • Research Site

    Livingstone

  • Research Site

    London

  • Research Site

    Manchester

  • Research Site

    Metropolitan Borough of Wirral

  • Research Site

    Middlesbrough

  • Research Site

    Norwich

  • Research Site

    Nottingham

  • Research Site

    Oldham

  • Research Site

    Oxford

  • Research Site

    Plymouth

  • Research Site

    Rochdale

  • Research Site

    Salford

  • Research Site

    Swansea

  • Research Site

    Torquay

  • Research Site

    Wakefield

Other trials in United Kingdom

About this study

Official title: An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Conditions
Type 2 Diabetes
Being tested
exenatide, insulin glargine
Keywords
diabetes, exenatide, insulin glargine, Lilly, Amylin
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, 5mcg or 10mcg, twice a day

  • insulin glargineDrug

    Also called Lantus

    subcutaneous injection, titrated to target blood glucose level, once a day

Study groups in NCT00360334
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: exenatide
2Active comparatorNot described
Receives: Drug: insulin glargine

What is being measured

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

  1. Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)

    Composite endpoint evaluating effect of treatment on glycemic control and weight

    Measured: 26 weeks

Secondary outcomes (27)

  1. Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg

    Composite endpoint evaluating effect of treatment on glycemic control and weight

    Measured: 26 weeks

  2. Change in Fasting Serum Glucose

    Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)

    Measured: 26 weeks

  3. Percent of Patients Achieving HbA1c ≤ 7.4%

    Percent of patients achieving specified HbA1c target at endpoint

    Measured: 26 weeks

  4. Percent of Patients Achieving HbA1c < 7%

    Percent of patients achieving specified HbA1c target at endpoint

    Measured: 26 weeks

  5. Percent of Patients Achieving HbA1c < 6.5%

    Percent of patients achieving specified HbA1c target at endpoint

    Measured: 26 weeks

  6. Change in 7 Point Self Monitored Blood Glucose Profile

    Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day

    Measured: 26 weeks

  7. Change in Body Mass Index (BMI)

    Change in BMI from baseline to endpoint

    Measured: 26 weeks

  8. Change in Waist Circumference

    Change in waist circumference from baseline to endpoint

    Measured: 26 Weeks

  9. Change in Waist-to-hip Ratio

    Change in waist-to-hip ratio from baseline to endpoint

    Measured: 26 weeks

  10. Change in Body Weight

    Change in body weight from baseline to endpoint

    Measured: 26 weeks

  11. Percent Change in Body Weight

    Percent change in baseline body weight at endpoint

    Measured: 26 Weeks

  12. Percent of Patients Achieving 5% Weight Loss

    Percent of patients who lost at least 5% of baseline body weight at endpoint

    Measured: 26 weeks

  13. Percent of Patients Achieving 10% Weight Loss

    Percent of patients who lost at least 10% of baseline body weight at endpoint

    Measured: 26 weeks

  14. Change in Systolic Blood Pressure

    Change in systolic blood pressure from baseline to endpoint

    Measured: 26 weeks

  15. Change in Diastolic Blood Pressure

    Change in diastolic blood pressure from baseline to endpoint

    Measured: 26 weeks

  16. Change in Fasting Serum Total Cholesterol (TC)

    Change in TC from baseline to endpoint

    Measured: 26 weeks

  17. Change in High Density Lipoprotein (HDL) Cholesterol

    Change in HDL cholesterol from baseline to endpoint

    Measured: 26 weeks

  18. Change in TC to HDL Cholesterol Ratio

    Change in TC to HDL cholesterol ratio from baseline to endpoint

    Measured: 26 weeks

  19. Change in Fasting Serum Triglycerides

    Change in fasting serum triglycerides from baseline to endpoint

    Measured: 26 weeks

  20. Change in Low Density Lipoprotein (LDL) Cholesterol

    Change in LDL cholesterol from baseline to endpoint

    Measured: 26 weeks

  21. Change in Apolipoprotein-B

    Change in apolipoprotein-B from baseline to endpoint

    Measured: 26 weeks

  22. Incidence of Hypoglycemic Episodes

    Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study

    Measured: 26 weeks

  23. Incidence of Nocturnal Hypoglycemic Episodes

    Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study

    Measured: 26 weeks

  24. Incidence of Severe Hypoglycemic Episodes

    Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study

    Measured: 26 weeks

  25. Hypoglycemic Rate Per 30 Days

    Number of hypoglycemic episodes per patient adjusted per 30 days

    Measured: 26 weeks

  26. Nocturnal Hypoglycemic Rate Per 30 Days

    Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days

    Measured: 26 weeks

  27. Severe Hypoglycemic Rate Per 30 Days

    Number of severe hypoglycemic episodes per patient adjusted per 30 days

    Measured: 26 weeks

Timeline

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

  1. First posted4 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionApr 2008
  4. Study completionApr 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
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360334
Sponsor's protocol ID
H8O-BP-GWBG
Status last verified
Mar 2015
First submitted
2 Aug 2006
Last updated
7 Apr 2015
Data monitoring committee
No

Publications

  • Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.x.

    PubMed 19930005

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide and insulin glargine in people with Type 2 Diabetes, run by AstraZeneca at 31 sites in United Kingdom.

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 4 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 31 sites in United Kingdom. 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 5 Jun 2009). 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?

Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) (time frame: 26 weeks). 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 NCT00360334, which also lists 2 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; AzTrials last refreshed its copy on 29 Oct 2026.

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