CTRI/2014/09/005054Other3 期
Comparison of LY2605541 versus Insulin Glargine asBasal Insulin Treatment in Combination with OralAnti-Hyperglycemia Medications in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: An Open-Label,Randomized, 52-week Study
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 663
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Have T2DM (per World Health Organization [WHO] Classification of Diabetes) not treated with insulin.
- •-Have had diabetes for at least 1 year.
- •-Have been receiving at least 2 oral antihyperglycemic medications (OAMs) for at least 3 months prior to the study.
- •-Have hemoglobin A1c (HbA1c) of 7.0 percent to 11.0 percent, inclusive, according to central lab at screening.
- •-Have body mass index (BMI) greater than equal to 40 kilogram/square meter (kg/m2).
- •-This inclusion criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) only, are not breastfeeding, test negative for a serum pregnancy test, intend not to become pregnant during study or willing to have a reliable method of birth control.
排除标准
- •-Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks. Insulin use of any duration during pregnancy is not considered an exclusion criterion.
- •-Concomitant medications: rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) used concurrently or within 3 months prior to screening.
- •-Local OAM restrictions: for participants on OAMs, restrictions for cardiac, renal, hepatic diseases and maximum dose, local product regulations must apply.
- •-Weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-the-counter medications to promote weight loss.
- •-Severe hypoglycemia history: have had any episodes of severe hypoglycemia within 6 months prior to screening.
- •-Diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar nonketotic coma (HHNKC): have had 1 or more episodes of DKA or hyperosmolar state/coma in the past 6 months.
- •-Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification).
- •-Renal: have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine >=2 milligram/deciliter (mg/dL) (177 micromole/liter [mol/L]).
- •-Hepatic: have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements.
- •-Lipid-lowering medications:Are using niacin preparations as a lipid-lowering medication or bile acid sequestrants within 90 days prior to screening
- •-Are using lipid-lowering medication at a dose that has not been stable for >=90 days prior to screening.
研究者
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