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Type 2 Diabetes MellitusPhase 4NCT00870194

A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

A Phase 4 study testing exenatide and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 36 sites in 7 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 determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
exenatide and sitagliptin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
36 sitesin 7 countries
Study dates
Mar 2009to Apr 2010
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Present with type 2 diabetes
  • Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
  • 100 mg/day sitagliptin and
  • ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
  • Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
  • Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2

Who cannot join

  • Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have previously completed or withdrawn from this study or any other study investigating exenatide.
  • Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
  • Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
  • Are currently treated with any of the following excluded medications:
  • Thiazolidinediones (TZD) within 3 months of screening.
Show all 14Show fewer
  • Sulfonylurea (SU) within 3 months of screening.
  • Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.
  • Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
  • Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
  • Exogenous insulin within the 3 months prior to screening.
  • Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
  • Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
  • Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Trial locations and contacts

36 sites in 7 countries.

36 sites in 7 countries

Germany15 sites

  • Research Site

    Aschaffenburg

  • Research Site

    Aßlar

  • Research Site

    Beckum-Neubeckum

  • Research Site

    Berlin

  • Research Site

    Bosenheim

  • Research Site

    Essen

  • Research Site

    Falkensee

  • Research Site

    Furth im Wald

  • Research Site

    Grevenbroich

  • Research Site

    Hohenmölsen

  • Research Site

    Leipzig

  • Research Site

    Neuwied

  • Research Site

    Othmarschen

  • Research Site

    Pohlheim

  • Research Site

    Speyer

Other trials in Germany

India5 sites

  • Research Site

    Ahmedabad

  • Research Site

    Bangalore

  • Research Site

    Coimbatore

  • Research Site

    Indore

  • Research Site

    Jaipur

Other trials in India

Mexico5 sites

  • Research Site

    Coatzacoalcos

  • Research Site

    Guadalajara

  • Research Site

    Mérida

  • Research Site

    Monterrey

  • Research Site

    Tampico

Other trials in Mexico

South Korea4 sites

  • Research Site

    Daegu

  • Research Site

    Gwangju

  • Research Site

    Seoul

  • Research Site

    Ulsan

Other trials in South Korea

Australia3 sites

  • Research Site

    Adelaide

  • Research Site

    Geelong

  • Research Site

    Melbourne

Other trials in Australia

Argentina2 sites

  • Research Site

    Buenos Aires

  • Research Site

    Morón

Other trials in Argentina

Greece2 sites

  • Research Site

    Athens

  • Research Site

    Thessaloniki

Other trials in Greece

About this study

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

Being tested
exenatide and sitagliptin, exenatide and placebo
Keywords
diabetes, exenatide, Byetta, sitagliptin, Januvia, 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 and sitagliptinDrug

    Also called exenatide-Byetta; sitagliptin-Januvia

    exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day

  • exenatide and placeboDrug

    Also called exenatide-Byetta

    exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Study groups in NCT00870194
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: exenatide and sitagliptin
2Placebo comparatorNot described
Receives: Drug: exenatide and placebo

What is being measured

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

  1. Change in HbA1c (Percent)

    Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]

    Measured: Baseline to 20 Weeks

Secondary outcomes (16)

  1. Percentage of Patients Achieving HbA1c <=7.0%

    Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  2. Percentage of Patients Achieving HbA1c <7.0%

    Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  3. Percentage of Patients Achieving HbA1c <=6.5%

    Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  4. Change in FSG (mmol/L)

    Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  5. Change in Body Weight (kg)

    Change in body weight from baseline to endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  6. Change in Waist Circumference (cm)

    Change in waist circumference from baseline to endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  7. Waist-to-Hip Ratio

    Change in waist-to-hip ratio from baseline to endpoint (Week20)

    Measured: Baseline to 20 Weeks

  8. SMBG (mmol/L)

    7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)

    Measured: Baseline to 20 Weeks

  9. Change in Triglycerides (mmol/L)

    Change in triglycerides from baseline to endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  10. Change in HDL (mmol/L)

    Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  11. Change in LDL (mmol/L)

    Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  12. Change in Total Cholesterol (mmol/L)

    Change in total cholesterol from baseline to endpoint (Week 20)

    Measured: Baseline to 20 Weeks

  13. Incidence of Hypoglycemia (Overall)

    Incidence of hypoglycemic episodes experienced overall during the study

    Measured: Baseline to 20 Weeks

  14. Incidence of Severe Hypoglycemia(Overall)

    Incidence of severe hypoglycemia experienced overall during the study

    Measured: Baseline to 20 Weeks

  15. Incidence of Nocturnal Hypoglycemia (Overall)

    Incidence of nocturnal hypoglycemia experienced overall during the study

    Measured: Baseline to 20 Weeks

  16. Incidence of Confirmed Hypoglycemia(Overall)

    Incidence of confirmed hypoglycemia experienced overall during the study

    Measured: Baseline to 20 Weeks

Timeline

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

  1. First posted27 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionApr 2010
  4. Study completionApr 2010

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00870194
Sponsor's protocol ID
H8O-CR-GWDK
Status last verified
Mar 2015
First submitted
25 Mar 2009
Last updated
9 Apr 2015
Data monitoring committee
No

Publications

  • Violante R, Oliveira JH, Yoon KH, Reed VA, Yu MB, Bachmann OP, Ludemann J, Chan JY. A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitagliptin. Diabet Med. 2012 Nov;29(11):e417-24. doi: 10.1111/j.1464-5491.2012.03624.x.

    PubMed 22375612

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing exenatide and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 36 sites in 7 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 6 inclusion and 14 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 9 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 36 sites in Germany, India, Mexico, South Korea, Australia and 2 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 17 Jun 2011). 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 HbA1c (Percent) (time frame: Baseline to 20 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 NCT00870194, 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 9 Apr 2015.

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