Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: LY2189265
Product Code: LY2189265
Pharmaceutical Form: Solution for injection
Current Sponsor code: LY2189265
Other descriptive name: LY2189265
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Eli Lilly and Company - Indianapolis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have type 2 diabetes for at least 6 months prior to entering the trial [2] Are treated with diet and exercise, are taking metformin as monotherapy or in combination with another OAM, or are taking another OAM as monotherapy [3] Have an HbA1c value of =7.0% to =9.5% [4] Men or women who are between the ages of 18 to 75 years [5] Females of childbearing potential (not surgically sterilized & between menarche & 1-year postmenopausal) must test negative for pregnancy at Visit 1: agree to use a reliable method of birth control; & not be breastfeeding [6] Have a body mass index (BMI) between 25 and 40 kg/m2 [7] Have a stable weight during the 3 months prior to Visit 1 [8] Well motivated, capable, and willing to perform SMBG testing; learn how to self-inject treatment (or with assistance for those with physical limitations); & maintain a study diary [9] Have given written informed consent to participate in this study 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
Exclusion criteria
Exclusion criteria: [10] Have known type 1 diabetes [11] Have been treated with a GLP-1 analog within 6 months prior to Visit 1 or are being treated with insulin [12] Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass (bariatric) surgery, or chronically take drugs that directly reduce gastrointestinal motility [13] Are currently taking prescription or over-the-counter medications to promote weight loss [14] Have had a listed cardiovascular event (see protocol) within 6 months prior to Visit 1 or between Visits 1 and 4 [15] Have poorly controlled hypertension (as defined in protocol), renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension [16] At Visit 1, an ECG reading considered outside the normal limits & relevant for interpretation or indicating cardiac disease; aberrant, blocked, or impaired propagation; and clinically significant signs of ischemic heart disease [17] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, a history of chronic pancreatitis or idiopathic acute pancreatitis, or ALT levels >3.0 times the upper limit of the reference range at Visit 1 [18] Have a serum creatinine =1.5 mg/dL, or a creatinine clearance 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Visit 1 [23] Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years [24] Have any other condition (such as, known drug or alcohol abuse or psychiatric disorder) that may preclude the patient from following and completing the protocol [25] Have any contraindication, known allergy, or hypersensitivity to metformin, sitagliptin, or excipients contained in these products [26] Are currently taking a central nervous system stimulant [27] Are investigator site personnel directly affiliated with this study and/or their immediate families [28] Are Lilly employees [29] 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 (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [30] Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • to demonstrate that the glycemic control of the high dose of LY2189265 selected at the Decision Point is noninferior to that of sitagliptin at 12 months (52 weeks), as measured by HbA1c change from baseline in patients with type 2 diabetes on metformin.;Secondary Objective: To demonstrate that • the high dose of LY2189265 is superior to placebo at 6 months • the high dose of LY2189265 is superior to sitagliptin at 12 months • the low dose of LY2189265 is superior to placebo at 6 months • the low dose of LY2189265 is noninferior to sitagliptin at 12 months • the low dose of LY2189265 is superior to sitagliptin at 12 months Additional secondary objetives are included and outlined in the protocol.;Primary end point(s): The primary efficacy measure of this study is HbA1c change from baseline at 12 months | — |
Countries
France, Germany, Spain
Outcome results
None listed