Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2009/091/000105
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 168
Diabetes mellitus, type 2
-Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
-Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
-Have a qualifying HbA1c value, as determined by the central laboratory: at screening (for diet and exercise only = greater than or equal to 7.0% to less than or equal to 9.5%; for metformin monotherapy = >6.0% to less than or equal to 8.5%) and at time of randomization for all patients = greater than or equal to 7.0% to less than or equal to 9.5%
-Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
-Have a body mass index (BMI) between 23 and 40 kg/m2, inclusive, for patients who are native to, and reside in, South and/or East Asia; all other patients must have a BMI between 25 and 40 kg/m2, inclusive.
-Stable weight for 3 months prior to screening
-Diabetes mellitus, type 1
-Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
-Use of GLP-1 analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
-Use of medications (prescription or over-the counter) to promote weight loss
-Chronic (>2 weeks) use of systemic glucocorticoid therapy
-Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
-Use of CNS stimulant (for example, Ritalin-SR)
-Cardiovascular event within 6 months prior to screening
-Poorly controlled hypertension (determined by a mean seated systolic BP greater than or equal to 160 mm Hg or mean seated diastolic BP greater than or equal to 95 mm Hg at screening or randomization)
-ECG reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
-Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times upper limit of normal
-Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
-Amylase greater than or equal to 3 times the upper limit of normal and/or lipase greater than or equal to 2 times upper limit of normal which are determined by central labs at the time of screening
-Serum creatinine greater than or equal to 1.5 mg/dL for men or greater than or equal to 1.4 mg/dL for women or a creatinine clearance <60 mL/minute which are determined by central labs at the time of screening
-Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
-Significant active, uncontrolled endocrine or autoimmune abnormality
-History of a transplanted organ (corneal transplants are allowed)
-Active or untreated 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 any other condition, in the opinion of the investigator, that may preclude the patient from following or completing the protocol
-Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
-Sponsor employees
-Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
-Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
-Have previously completed or withdrawn from this study after providing informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method