a study in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the study is designed to see if once daily oral dosing of ly2608204 will help control diabetes as measured by the glycosylated fraction of hemoglobin a (hba1c) level. it will also help to determine the safety of the medication and the most useful doses of the medication.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus prior to entering the trial * may be treated with: 1. diet and exercise alone or 2. diet and exercise in combination with a stable dose of metformin for at least 3 months before screening or 3. diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before screening or 4. diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before screening and have had diabetes for at least 6 years * must have an hemoglobin a1c value between 7% and 10% * must have a body mass index (bmi) between 20 and 40 kg/m2 * must have stable weight during the 3 months prior to screening (weight change not to exceed 5 kg (11 lb)) * if female, you must not be able to get pregnant * must be well motivated, capable, and willing to complete study required glucose monitoring and instruction exclusion criteria: * use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to screening * have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery * have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months * are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight * have cardiac disease with functional status that is new york heart association \[nyha\] class ii, iii, or iv or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months. * have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. doses of antihypertensive medications must be stable for 30 days before randomization * have a qtcb (bazett's-corrected qt interval) interval greater than 450 msec for men or greater than 470 for women at screening or any personal history of ventricular tachycardia or unexplained syncope * have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests * are currently receiving renal dialysis, have a serum creatinine greater than 2.0 mg/dl (177 μmol/l) or a calculated creatinine clearance of less than 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label * have fasting state hypertriglyceridemia (defined as greater than 5.65 mmol/l, 500 mg/dl) at screening. if taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization. * are receiving chronic (for more than 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to randomization * 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 * have a history of seizure disorder * are currently using or intend to use inhibitors of cytochrome p450 family 3a (cyp3a4) * currently taking a medication that is a sensitive substrate of the cyp3a4 pathway with a narrow therapeutic index

Keywords: diabetes glimepiride diabetes type ii diabetes type 2 type 2 diabetes diabetes mellitus