EUCTR2007-002150-39-HU进行中（未招募）不适用
The COMPLETE T2D Trial: COMParison of Insulin Lipsro Protamine Suspension and DETEmir in Type 2 Diabetes Mellitus: Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal Therapy for Patients with Type 2 Diabetes Mellitus - COMPLETE T2D Trial
Eli Lilly and Company Ltd.0 个研究点目标入组 378 人开始时间: 2007年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 378
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 type 2 diabetes mellitus (T2DM; World Health Organization [WHO] classification, Protocol Attachment IOOY.2) for at least 1 year.
- •[2] Are >= 18 years old.
- •[3] Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following table:
- •Metformin, Minimum Dose: 1500 mg/day
- •Sulfonylureas and Dipeptidyl peptidase-IV (DPP-IV) inhibitors1, Minimum Dose: 1/2 the maximum daily dose, according to the local package insert.
- •Thiazolidinediones, Minimum Dose: 30 mg/day pioglitazone or 4 mg/day rosiglitazone
- •The OAMs also must be used in accordance with the product label and be approved for use with insulin in the patient’s country. (Note: Combination treatments of the OAMs listed above are acceptable if they meet the above criteria. For example, Avandamet [rosiglitazone maleate and metformin hydrochloride] would cover the categories of a thiazolidinedione (TZD) and metformin.)
- •[4] Have a hemoglobin A1c (HbA1c) >=7.5% and <=10.0%, as measured by a central laboratory before Visit 2.
- •[5] Body mass index (BMI) >= 25 and <=45 kg/m2.
- •[6] As determined by the investigator, are capable and willing to do the following:
- •use the insulin injection device according to the instructions provided;
- •inject insulin while continuing to use the prestudy regimen of OAMs specified in Inclusion Criterion [3];
- •perform self monitoring of blood glucose (SMBG);
- •complete the study diary as required for this protocol;
- •are receptive to diabetes education, including continuing their prestudy diet and activity levels, or following simple dietary advice as appropriate;
- •comply with the required study visits and willing to receive regular telephone calls between visits.
- •[7] Have given written informed consent to participate in this study in accordance with local regulations.
- •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
排除标准
- •[8] Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- •[9] Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- •[10] Have had more than 1 episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- •[11] Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- •[12] Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
- •[13] Women who are breastfeeding.
- •[14] Have cardiac disease with functional status that is Class III or IV; or, if taking a TZD, have congestive heart failure of a less severe functional status, which would contraindicate in their respective country the use of TZD alone or in combination with insulin.
- •[15] Have a history of renal transplantation or are currently receiving renal dialysis or creatinine >2.0 mg/dL (177 µmol/L).
- •[16] Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
- •[17] Patients with a malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
- •[18] Have 1 of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease or any other serious disease considered by the investigator to be exclusionary.
- •[19] Have known hypersensitivity or allergy to any of the study insulins or their excipients.
- •[20] Have had a blood transfusion or severe blood loss within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology.
- •[21] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
- •[22] Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night), in the investigator’s opinion.
- •[23] Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol, according to the investigator’s judgment.
- •[24] Have 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.
- •[25] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or siblin
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