A clinical trial comparing the effects of experimental drug versus placebo and an approved drug in once-weekly dosing for patients diagnosed with Type 2 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2016-004179-33-PL
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 316
•Have T2DM for at least 6 months before screening based on the disease diagnostic criteria (According to World Health Organization [WHO] Classification).
•Have an HbA1c value at screening of =7.0% and =10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, =1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening. Note: patients from some countries may be required to be on metformin in order to enroll in the protocol, per EU directive CHMP/EWP/1080/00 Rev.1.
•Male or female patients 18 to 75 years of age, inclusive
•Male patients: Male patients should be willing to use reliable contraceptive methods throughout the study and for at least 3 months after last injection
•Female patients: Female patients must not be of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
Women with an intact uterus are deemed postmenopausal if they are =45 years old, and
have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year, OR
have had at least 6 months of amenorrhea with follicle-stimulating hormone (FSH) and estradiol levels consistent with a postmenopausal state (FSH =40mIU/mL and estradiol =30 pg/mL).
Women of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
• test negative for pregnancy at Screening based on a serum pregnancy test AND
• if sexually active, agree to use either 1 highly effective form of contraception or 2 effective forms of contraception for the duration of the trial and up to 30 days thereafter.
• not be breastfeeding.
•Have a BMI between 23 and 50 kg/m2 (inclusive) at screening.
•Informed Consent
In the investigator’s opinion, are well motivated, capable, and willing to:
• perform self-monitoring of blood glucose (SMBG)
• self-inject up to 4 injections each week
• complete study diary/ies, as required for this protocol
• prepare and administer (with assistance if necessary) study medication
• are receptive to continuing their pre-study diet, activity levels, and follow simple dietary advice as appropriate
•Be willing to maintain metformin dose during the trial, if taking a stable dose of metformin at study entry. Patients experiencing hypoglycemia during the study may have their metformin dose reduced.
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 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
Medical Conditions
•Have type 1 diabetes mellitus.
•Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening Visit.
•Have had more than 1 episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Any patient that the investigator feels will not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded.
•Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (greater than 2 times the upper limit of normal [ULN]) or fasting serum triglyceride level of >500 mg at screening.
•Have a diagnosis of gastroparesis or history of bariatric surgery or a clinically significant gastric emptying abnormality, in the opinion of the investigator.
•Have active proliferative diabetic retinopathy.
•Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, a history of pancreatitis, or alanine transaminase (ALT) levels >2.5 times the upper limit of the reference range at Screening, as determined by the central laboratory at screening.
•Have a known self or family history of multiple endocrine neoplasia (MEN) type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
•Evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone (TSH) which, in the opinion of the investigator, would pose a risk to patient safety. Subjects on a stable dose of thyroid replacement therapy for at least the prior 3 months who are clinically euthyroid and who are anticipated to remain on this dose throughout the trial period may be eligible if they meet the other criteria.
•Have a screening calcitonin =20 pg/mL as determined by the central laboratory at Screening.
•Have an electrocardiogram (ECG) considered by the investigator indicative of active cardiac disease or with abnormalities that may interfere with the interpretation of changes in ECG intervals at screening.
A QTc interval greater than 450 msec in men and greater than 470 in women is specifically excluded.
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