EUCTR2012-005174-56-DE进行中（未招募）不适用
A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients with Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study: The IMAGINE 8 Study - The IMAGINE 8 Study
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
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, based on the World Health Organization (WHO) classification, for =1 year.
- •[2]Are 18-70 years of age, inclusive.
- •[3]Use any type of basal insulin (except degludec), including once-or twice-daily human insulin NPH, insulin detemir, or insulin glargine.
- •[4]Have HbA1c levels =9.0% according to central laboratory testing at Visit 1.
- •[5]Have BMI =40.0 kg/m2.
- •[6]Have been treated with stable doses of insulin for at least 30 days before Visit 1 with:
- •Basal insulin with daily doses ±30% of mean during the last 4 weeks.
- •Doses of a basal insulin must be between 0.3 U/kg/day and 1 unit/kg/day.
- •[7]If on metformin, TZDs, SGLT-2 inhibitors, or DPP4 inhibitors, must be on stable doses for the last 30 days.
- •[8]This inclusion criterion applies to all females of child-bearing potential:
- •Are not breastfeeding.
- •Test negative for pregnancy at Visits 1and 3 based on a serum pregnancy test.
- •Intend not to become pregnant during the study.
- •Have practiced reliable methods 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 before screening.
- •Agree to continue to use reliable methods of birth control as determined by the investigator during the study (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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •[14] Are using prandial, self-mixed, or premixed insulin. Patients using prandial
- •insulin may be switched to daily glargine if investigator judges that the patient
- •will still meet fasting glucose requirements for randomization.
- •[15] Are using insulin pump therapy.
- •[16] Have excessive insulin resistance: Defined as >1.0 U/kg/day as baseline
- •[17] If being treated with SUs before Visit 1, then must have SUs washed out
- •between Visit 1 and Visit 2.
- •[18] Use any of these concomitant medications: morphine, codeine, antidiuretics,
- •glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide,
- •exenatide once weekly, lixisenatide or liraglutide), or pramlintide, used
- •concurrently or within 90 days before Visit 1 (screening).
- •[19] Have hypoglycemia unawareness, defined as confirmed by laboratory test
- •results or by historical episodes of hypoglycemia <54 mg/dL (3.0 mmol/L)
- •without symptoms.
- •[20] Have fasting hypertriglyceridemia >400 mg/dL (>4.5 mmol/L) at Visit 1, as
- •determined by the local laboratory.
- •[21] If currently taking prescription or over-the-counter medications to promote
- •weight loss, should discontinue use of the medication at Visit 1.
- •[22] Have had any episode of severe hypoglycemia (defined by requiring
- •assistance due to neurologically disabling hypoglycemia) within 6 months
- •before entry into the study.
- •[23] Have had 2 or more emergency room visits or hospitalizations due to poor
- •glucose control in the past 6 months.
- •[24] Have had a previous clinically significant episode of ketoacidosis as
- •determined by the investigator (ketone bodies at fasting and without acidosis
- •is acceptable) in the past 6 months. If the investigator is in doubt, C-peptide
- •should be measured, and patients should be excluded if confirmed as Cpeptide
- •negative (while having a fasting C-peptide in the normal range).
- •[25] Have 1 of the following concomitant diseases: clinically significant
- •hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease or
- •positive for human immunodeficiency virus (HIV), or have signs of active
- •hepatitis B or C as determined by the investigator, for participation.
- •[26] Have known history of cardiovascular disease (including angina, transient
- •ischemic attack [TIA], significant arrhythmia, stroke, myocardial infarction
- •[MI], or peripheral vascular disease), or history of coronary artery bypass
- •graft (CABG) or percutaneous coronary interventions (such as coronary
- •arterial stent insertion or coronary angioplasty).
- •[27] Have cardiac disease with functional status that is New York Heart
- •Association Class III or IV (per New York Heart Association Cardiac Disease
- •Classification) (Attachment 7).
- •[28] Have history of seizure disorder.
- •[29] Have history of renal transplantation, are currently receiving renal dialysis, or
- •have estimated Glomerular Filtration Rate (eGFR) <60 mL/min (Chronic
- •Kidney Disease Epidemiology Collaboration [CKD-EPI]).
- •[30] Have any known metabolic or lactic acidosis; have any condition associated
- •with hypoperfusion, hypoxemia, dehydration, or sepsis; or have had a
- •radiologic contrast study within 48 hours before study entry.
- •[31] Have obvious clinical signs or symptoms of liver disease (excluding
- •nonalcoholic fatty liver disease), acute or chronic hepatitis, nonalcoholic
- •steatohepatitis, or elevated liver enzyme measurements as indicated below:
- 另有 2 项未显示
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