EUCTR2011-005866-39-ES进行中（未招募）1 期
A Comparison of LY2605541 versus Insulin Glargine Alone or in Combination with Pre study Oral Antihyperglycemic Medications in Patients with Type 2 Diabetes Mellitus Previously Treated with Basal Insulin:An Open-Label, Randomized StudyThe IMAGINE 5 Study - IMAGINE 5
illy S.A.0 个研究点目标入组 466 人开始时间: 2012年2月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 466
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1]Have T2DM (per World Health Organization [WHO] Classification of Diabetes)
- •[2]Are 18 years of age or older
- •[3]Have had diabetes for at least 1 year
- •[4]Have been receiving basal insulin (NPH [isophane], insulin detemir or insulin glargine) and from 0 to 3 OAMs for at least 90 days prior to the study. Doses of any OAMs are required to have been stable for ?90 days prior to screening and at least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose.
- •?Note: OAMs must be used in accordance with the corresponding product label at the time of screening. Combination treatments of the OAMs are acceptable if they meet the above criteria. Combination medications should be counted as the number of individual components.
- •[5]Have HbA1c ?9.0% according to central lab at screening
- •[6]Have BMI ?45.0 kg/m2
- •[7]Are capable of, and willing to do, the following, as determined by the investigator:
- •?Inject insulin with a prefilled pen and perform self blood glucose monitoring, and
- •?Record keeping as required by this protocol.
- •Caregiver may be responsible for all of the above.
- •[8]This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) only:
- •?Are not breastfeeding;
- •?Test negative for pregnancy at the time of screening and randomization based on a serum pregnancy test;
- •?Intend not to become pregnant during the study;
- •?Have practiced a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy, or abstinence) for at least 6 weeks prior to screening.
- •?Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug).
- •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 307
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 119
排除标准
- •[12]Insulin therapy: have used a routine regimen of insulin glargine twice daily in the past 90 days or have used routine, prandial (rapid-acting) insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks. Insulin use of any type or of any duration during pregnancy is not considered an exclusion criterion.
- •[13]Concomitant medications: rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP 1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) used concurrently or within 90 days prior to screening.
- •[14]Local OAM restrictions: for patients on OAMs, restrictions for cardiac, renal, and hepatic diseases in the local product regulations must apply.
- •[15]Weight loss medications: are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss.
- •[16]Severe hypoglycemia history: have had any episodes of severe hypoglycemia within 6 months prior to screening.
- •[17]Diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar nonketotic coma (HHNKC): have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months.
- •[18]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)
- •[19]Renal: have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ?2 mg/dL (177 ?mol/L).
- •[20]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 as indicated below:
- •?total bilirubin ?2 x the upper limit of normal (ULN) as defined by the central laboratory, or
- •?alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) >2.5 x ULN, as defined by the central laboratory, or
- •?aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT) >2.5 x ULN, as defined by the central laboratory.
- •[21]Hematologic: have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- •[22]Malignancy: have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator.
- •[23]Allergy: have known hypersensitivity or allergy to any of the study insulins or their excipients.
- •[24]Glucocorticoid therapy: are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening.
- •[25]Triglycerides: have fasting triglycerides >400 mg/dL (>4.5 mmol/L) at screening as determined by the central laboratory.
- •[26]Sleep cycle: have irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night) in the investigator?s opinion.
- •[27]Adherence to protocol: have any othe
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