Efficacy of Once-Weekly Exenatide versus Once or Twice Daily Insulin Detemir in Patients with Type 2 Diabetes Treated with Metformin Alone or in Combination with Sulphonylurea - D3
- Conditions
- DiabetesMedDRA version: 14.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2009-010830-23-GB
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 257
[1]Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO) (refer to Attachment GWDL.3).
[2]Are at least 18 years of age at screening.
[3]Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive.
[4]Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
[5]Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.
[6]Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to visit 3
Or
Are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to visit 3.
[7]For females of child-bearing potential (not surgically sterilised and between menarche and 1-year postmenopause) only:
•Are not breastfeeding
•Test negative for pregnancy at the time of screening based on a urine pregnancy test
•Intend not to become pregnant during the study
•Have practiced a reliable method of birth control (e.g. use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy for at least 6 weeks prior to screening)
•Agree to continue to use a reliable method of birth control (as above) 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
[8] Are Lilly, Amylin, or Alkermes employees.
[9] Are investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
[10] Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure (New York Heart Association Class III or IV), coronary artery bypass surgery or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study.
[11] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic pyruvic transaminase (SGPT), greater than three times the upper limit of the reference range.
[12] Have a history of renal transplantation or are currently receiving renal dialysis or have a creatinine clearance of <30 mL/min (using the Cockcroft-Gault formula).
[13] Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
[14] Have known haemoglobinopathy or chronic anaemia (haemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females).
[15] Patients with a history of severe gastrointestinal disorder (e.g. gastroparesis)
[16] Have had greater than three episodes of major hypoglycaemia within 6 months prior to screening (refer to Section 9.5.1.1 for more information on hypoglycaemia).
[17] Have any contraindication for the OAD that they have been using.
[18] Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents.
[19] Are known to have active proliferative retinopathy.
[20] Have fasting triglycerides levels > 500mg/dL (>5.64mmol/L)
[21] Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease).
[22] Have been treated with drugs that promote weight loss, within 3 months of screening.
[23] Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
•insulin
•alpha-glucosidase
•meglitinides
•Byetta® (exenatide BID formulation)
•thiazolidinediones (TZD)
•dipeptidyl peptidase (DPP)-4 inhibitors.
[24] Have had an organ transplant.
[25] Have donated blood within 30 days of screening.
[26] Have previously completed or withdrawn from this s
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