Clinical trial NCT00870194: A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
Official title: A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
Byetta
sitagliptin
Januvia
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-03-27
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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* Have previously completed or withdrawn from this study or any other study investigating exenatide.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.

Primary outcomes:
measure: Change in HbA1c (Percent)
timeFrame: Baseline to 20 Weeks
Secondary outcomes:
measure: Percentage of Patients Achieving HbA1c <=7.0%
timeFrame: Baseline to 20 Weeks
measure: Percentage of Patients Achieving HbA1c <7.0%
timeFrame: Baseline to 20 Weeks
measure: Percentage of Patients Achieving HbA1c <=6.5%
timeFrame: Baseline to 20 Weeks
measure: Change in FSG (mmol/L)
timeFrame: Baseline to 20 Weeks
measure: Change in Body Weight (kg)
timeFrame: Baseline to 20 Weeks
measure: Change in Waist Circumference (cm)
timeFrame: Baseline to 20 Weeks
measure: Waist-to-Hip Ratio
timeFrame: Baseline to 20 Weeks
measure: SMBG (mmol/L)
timeFrame: Baseline to 20 Weeks
measure: Change in Triglycerides (mmol/L)
timeFrame: Baseline to 20 Weeks
measure: Change in HDL (mmol/L)
timeFrame: Baseline to 20 Weeks
measure: Change in LDL (mmol/L)
timeFrame: Baseline to 20 Weeks
measure: Change in Total Cholesterol (mmol/L)
timeFrame: Baseline to 20 Weeks
measure: Incidence of Hypoglycemia (Overall)
timeFrame: Baseline to 20 Weeks
measure: Incidence of Severe Hypoglycemia(Overall)
timeFrame: Baseline to 20 Weeks
measure: Incidence of Nocturnal Hypoglycemia (Overall)
timeFrame: Baseline to 20 Weeks
measure: Incidence of Confirmed Hypoglycemia(Overall)
timeFrame: Baseline to 20 Weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Morón
country: Argentina
facility: Research Site
city: Adelaide
country: Australia
facility: Research Site
city: Geelong
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Asslar
country: Germany
facility: Research Site
city: Beckum-Neubeckum
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bosenheim
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Falkensee
country: Germany
facility: Research Site
city: Furth im Wald
country: Germany
facility: Research Site
city: Grevenbroich
country: Germany
facility: Research Site
city: Hamburg-Othmarschen
country: Germany
facility: Research Site
city: Hohenmolsen
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Neuwied
country: Germany
facility: Research Site
city: Pohlheim
country: Germany
facility: Research Site
city: Speyer
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Coimbatore
country: India
facility: Research Site
city: Indore
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
city: Coatzacoalcos
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Merida
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Tampico
country: Mexico
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: 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.