A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
1 other identifier
interventional
255
7 countries
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Mar 2009
Shorter than P25 for phase_4 type-2-diabetes-mellitus
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 25, 2009
CompletedFirst Posted
Study publicly available on registry
March 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
June 17, 2011
CompletedApril 9, 2015
March 1, 2015
1.1 years
March 25, 2009
April 11, 2011
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (Percent)
Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \[X% - Y%\]
Baseline to 20 Weeks
Secondary Outcomes (16)
Percentage of Patients Achieving HbA1c <=7.0%
Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <7.0%
Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <=6.5%
Baseline to 20 Weeks
Change in FSG (mmol/L)
Baseline to 20 Weeks
Change in Body Weight (kg)
Baseline to 20 Weeks
- +11 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
Eligibility Criteria
You may qualify if:
- Present with type 2 diabetes
- Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (36)
Research Site
Buenos Aires, Argentina
Research Site
Morón, Argentina
Research Site
Adelaide, Australia
Research Site
Geelong, Australia
Research Site
Melbourne, Australia
Research Site
Aschaffenburg, Germany
Research Site
Aßlar, Germany
Research Site
Beckum-Neubeckum, Germany
Research Site
Berlin, Germany
Research Site
Bosenheim, Germany
Research Site
Essen, Germany
Research Site
Falkensee, Germany
Research Site
Furth im Wald, Germany
Research Site
Grevenbroich, Germany
Research Site
Hohenmölsen, Germany
Research Site
Leipzig, Germany
Research Site
Neuwied, Germany
Research Site
Othmarschen, Germany
Research Site
Pohlheim, Germany
Research Site
Speyer, Germany
Research Site
Athens, Greece
Research Site
Thessaloniki, Greece
Research Site
Ahmedabad, India
Research Site
Bangalore, India
Research Site
Coimbatore, India
Research Site
Indore, India
Research Site
Jaipur, India
Research Site
Coatzacoalcos, Mexico
Research Site
Guadalajara, Mexico
Research Site
Mérida, Mexico
Research Site
Monterrey, Mexico
Research Site
Tampico, Mexico
Research Site
Daegu, South Korea
Research Site
Gwangju, South Korea
Research Site
Seoul, South Korea
Research Site
Ulsan, South Korea
Related Publications (1)
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.
PMID: 22375612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Chief Medical Officer, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2009
First Posted
March 27, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 9, 2015
Results First Posted
June 17, 2011
Record last verified: 2015-03