EUCTR2010-021516-42-FR进行中（未招募）1 期
Two Approaches to Escalate Lispro Therapy in Patients with Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone - AUTONOMY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 (per World Health Organization [WHO] Classification
- •of Diabetes).
- •[2] Are =18 and =85 years of age at the time of Visit 1.
- •[3] Have been treated for at least 90 days with insulin (glargine, NPH, or
- •detemir) in combination with oral antihyperglycemic agents as monotherapy,
- •dual, or triple therapy (sulfonylurea, meglitinide, metformin, pioglitazone, or
- •dipeptidyl peptidase-4 [DPP-4] inhibitor) and, in the opinion of the
- •investigator, requires further intensification of therapy.
- •[4] Are treated with insulin (glargine, NPH, or detemir) at least 20 U/day at
- •study entry.
- •[5] Have an HbA1c value >7.0% and =12.0% according to the central laboratory
- •at Visit 1.
- •Note: for patients who enter the study on NPH insulin or detemir, or on
- •glargine with HbA1c >7.0% and fasting blood glucose >120 mg/dL, a 6-week
- •lead-in period will be required for glargine optimization. For a patient on
- •glargine with HbA1c >7.0% and fasting blood glucose =120 mg/dL, no leadin
- •period is required and he or she may be randomized at Visit 2.
- •[6] Capable of, and willing, to do the following: inject insulin with a prefilled
- •pen and perform self blood glucose monitoring and record keeping as required
- •by this protocol, as determined by the investigator.
- •[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] Prior rapid- or short-acting insulin therapy: patients receiving scheduled
- •long-term short-acting or rapid-acting or premixed insulin therapy within the
- •past 6 months will not be eligible to participate in the study. Patients who have previously received short- or rapid-acting insulin as part of short-term
- •insulin therapy (during gestational diabetes, or during an acute hospitalization
- •or illness) or occasional use will be allowed to participate in this study.
- •Occasional use (e.g., used to treat acute hyperglycemia) shall be defined as
- •less than daily administration of not more than 1 dose per day of short- or
- •rapid-acting insulin.
- •[9] Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor
- •agonist (e.g., exenatide or liraglutide), alpha-glucosidase inhibitor (e.g.,
- •acarbose, miglitol, or voglibose) or rosiglitazone use concurrently or within 3 months prior to entry into study.
- •[10] Severe hypoglycemia: have had more than one episode of severe
- •hypoglycemia (defined as requiring assistance of a third party due to disabling
- •hypoglycemia) within 6 months prior to entry into the study.
- •[11] Excessive insulin resistance: received a total daily dose of insulin >2.0 U/kg
- •at the time of randomization.
- •[12] Morbid obesity: defined as a body mass index =45 kg/m2.
- •[13] Malignancy: have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
- •[14] 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) or have congestive
- •heart failure (CHF) requiring pharmacologic treatment or, in the investigator’s
- •opinion, have severe dependent edema (i.e., edema of the feet or ankles) or
- •have any condition associated with hypoperfusion, hypoxemia, dehydration,
- •[15] Renal: have a history of renal transplantation or are currently receiving renal
- •dialysis or have serum creatinine =2 mg/dL if not on metformin.
- •[16] Hepatic: have obvious clinical signs or symptoms of liver disease, acute or
- •chronic hepatitis, or alanine aminotransferase (ALT)/serum glutamic pyruvic
- •transaminase (SGPT) >3x the upper limit of the reference range as defined by
- •the central laboratory.
- •[17] Hematologic: have known hemoglobinopathy or chronic anemia or other
- •known blood disorder.
- •[18] Reproductive: (for women) are pregnant or intend to become pregnant
- •during the course of the study; are sexually active women of childbearing
- •potential not actively practicing birth control by a method determined by the
- •investigator to be medically acceptable; or are breastfeeding.
- •[19] Allergy: have known allergy to insulin lispro, insulin glargine, or excipients
- •contained in these products.
- •[20] Glucocorticoid therapy: receiving chronic (lasting longer than 2 weeks)
- •systemic glucocorticoid therapy (excluding topical and inhaled preparations)
- •or have received such therapy within 2 weeks immediately before Visit 1.
- •[21] Adherence to protocol: have any other condition (including known drug or
- •alcohol abuse or psychiatric disorder) that precludes the patient from
- •following and completing the protocol.
- •[22] Prior participation: are currently enrolled in, or have participated in, an
- •interventional medical, surgical, or pharmaceutical drug or device or off-label
- •use study (an investigational study in which a medical or surgical treatment
- •was given) wit
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