A Comparison of Adding Exenatide with Switching to Exenatide in Patients with Type 2 Diabetes Experiencing Inadequate Glycemic Control with Sitagliptin plus Metformin - GWDK
- Conditions
- Diabetes Mellitus type 2MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2008-006317-25-GR
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
[1] Present with type 2 diabetes as defined by the WHO criteria.
[2] Aged between 18 and 75 years of age, inclusive.
[3] 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).
[4] Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 10%, inclusive.
[5] Have a body mass index (BMI) =20kg/m2 and <45 kg/m2, and a history of stable body weight.
[6] This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only:
• Are not breastfeeding.
• Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
• Intend not to become pregnant during the study.
• Have practiced a reliable method of birth control for at least 6 weeks prior to screening.
• Agree to continue to use a reliable method of birth control during the study, as determined by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[7] Are investigator site personnel directly affiliated with this study and/or their immediate families.
[8] Are Lilly or Amylin employees.
[9] 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 or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[10] Have previously completed or withdrawn from this study or any other study investigating exenatide.
[11] Have had poorly controlled blood pressure within the last 4 weeks.
[12] Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
[13] Have characteristics contraindicating metformin, exenatide or sitagliptin use, according to product-specific label.
[14] Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study.
[15] Have a history of renal transplantation; or are currently receiving renal dialysis; or have serum creatinine =1.5 mg/dL (132 µmol/L) for males and =1.2 mg/dL (110 µmol/L) for females; or have an estimated creatinine clearance of <50 mL/min based on the standard Cockcroft-Gault formula.
[16] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, ALT, or SGPT greater than 2.5 times the upper limit of the reference range.
[17] Are known to have active proliferative retinopathy.
[18] Patients with a history of, or current, acute or chronic pancreatitis.
[19] Used drugs for weight loss within 1 month of screening.
[20] Are currently treated with any of the following excluded medications:
o Thiazolidinediones within 3 months of screening.
o Sulfonylurea
o Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin
o Meglitinide derivatives
o Alpha-glucosidase inhibitors
o Exogenous insulin within the 3 months prior to screening.
o Drugs that directly affect gastrointestinal motility
o Systemic corticosteroids
o Any other oral antidiabetic (OAD) agent
[21] Have an active or untreated malignancy, or have been in remission from clinically significant malignancy for less than 5 years.
[22] Have had an organ transplant.
[23] Have any other condition that renders them unable to understand the nature, scope, and possible consequences of the study or precludes them from following and completing the protocol, in the opinion of the investigator.
[24] Fail to satisfy the investigator of suitability to participate for any other reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method