NL-OMON38266已完成4 期
OpT2mise glucose control in type 2 Diabetes Mellitus (DM) with insulin pump therapy - OpT2mise
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Criteria for Inclusion at screening
- •1. Diagnosed with type 2 DM, as per Investigator diagnosis.
- •2. HbA1c (DCCT-standard) must be * 8.0% and *12% as evidenced by central lab value taken at screening.
- •3. Insulin resistance defined as required daily dose between 0.5-1.8 U/Kg or a maximum of 220 units insulin per day.
- •4. Age between 30-75 years old inclusive.
- •5. On MDI regimen (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as * 3 injections per day for at least 3 months prior signing the informed consent.
- •6. Ability to comply with technology, according to Investigator*s judgment.
- •7. Patients must be willing to undergo all study procedures.
- •8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator.;Criteria for Inclusion at randomization
- •1. Diagnosed with type 2 DM, as per Investigator diagnosis.
- •2. HbA1c (DCCT-standard) must be * 8.0% and *12% as evidenced by central lab value.
- •3. Insulin resistance defined as required daily dose between 0.7-1.8 U/Kg or a maximum of 220 units insulin per day.
- •4. On MDI (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as * 3 injections per day.
- •5. Ability to comply with technology, according to Investigator*s judgment.
- •6. * 2.5 SMBG per day on average, as reported in Carelink Clinical during the run-in period.
- •7. Patients must be willing to undergo all study procedures.
- •8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator.
排除标准
- •Criteria for Exclusion (screening and randomization)
- •1. Subject has a history (* 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
- •2. Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
- •3. Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
- •4. Subject has proliferative retinopathy or sight threatening maculopathy
- •5. Subject has
- •- an acute coronary syndrome (myocardial infarction or unstable angina) within 12 months OR
- •- coronary artery revascularization by bypass surgery or stenting within 3 months OR
- •- a transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 3 months OR
- •- hospitalization for heart failure within 3 months or current New York Functional Class III or IV OR
- •- current 2nd or 3rd degree heart block OR
- •- symptomatic ventricular rhythm disturbances OR
- •- thromboembolic disease within the last 3 months OR
- •6. Subject with renal impairment expressed as estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula < 30 ml/min as demonstrated by the screening central laboratory value at the time of enrollment
- •7. Subject has taken oral or injectable steroids within the last 30 days
- •8. Systolic blood pressure on screening visit is > 180 mmHg
- •9. Diastolic blood pressure on screening visit is > 110 mmHg
- •10. Any other disease (eg active cancer under treatment) or condition including abnormalities found on the screening tests, that in the opinion of the Investigator, may preclude the patient from participating in the study
- •11. Taking any medication prescribed for weight loss
- •12. Alcohol or drug abuse, other than nicotine, at the Investigator*s discretion
- •13. Use of a GLP-1 agonist or pramlitide (Symlin®). GLP-1 slows gastric emptying, thereby decreasing the rate of glucose absorption. Pramlitide (Symlin®) is a commercially available analogue of amylin, a synergistic partner to insulin.
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