EUCTR2006-003076-35-HU进行中（未招募）不适用
Treatment Strategies in Patients with Type 2 Diabetes Mellitus Not Achieving Glycemic Control while on Therapy with Premixed Insulin Analogues and Metformin: A Comparison of Insulin Lispro MM Intensive Mixture Therapy with Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70 - S019
Eli Lilly and Company Ltd.0 个研究点目标入组 270 人开始时间: 2006年7月27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
- 270
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 (World Health Organization [WHO] classification).
- •2. Are at least 30 years of age and less than 75 years of age.
- •3. Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 mg of metformin per day for at least 60 days immediately prior to the study.
- •4. Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1
- •Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 mg/dl [10.0 mmol/l].
- •5. As determined by the investigator, are capable and willing to
- •continue injections of insulin while continuing to use metformin as specified in inclusion Criterion [3],
- •learn how to use the insulin injection pen(s),
- •perform self blood glucose monitoring,
- •adjust doses of insulin according to the algorithm provided,
- •use the patient diary as required for this protocol,
- •be receptive to diabetes education
- •6. 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
- •7. Are taking any other OAMs not mentioned in inclusion criterion [3].
- •8. Have a body mass index greater than 40 kg/m2.
- •9. Have had more than one episode of severe hypoglycemia, as defined in Section 6.4, within 6 months prior to entry into the study.
- •10. 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.
- •11. Are women who are breastfeeding.
- •12. have cardiac disease with functional status that is Class III or IV (American Hearth Association)
- •13. Have congestive heart failure.
- •14. Have a history of renal transplantation or are currently receiving renal dialysis.
- •15. Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (ALT or AST greater than 2 times the upper limit of the reference range as defined by the local laboratory).
- •16. Are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.
- •17. Have known hypersensitivity or allergy to any of the study drugs or excipients of the study drugs.
- •18. Have had a blood transfusion or severe blood loss in the opinion of the investigator within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
- •19. Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
- •20. Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
- •21. Have any other condition (including known drug or alcohol abuse, psychiatric disorder) that precludes the patient from following and completing the protocol.
- •22. 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.
- •23. Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •24. Are employed by Lilly. Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility.
- •25. Have serum creatinine at a level that contraindicates metformin use according to the country-specific metformin product label.
- •26. Have known metabolic or lactic acidosis.
- •27. Have any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
- •28. Have had a radiologic contrast study within 48 hours prior to entry in the study or plan to have these procedures or surgery performed during the study.
- •Exclusion Criterion at Visit 2
- •29. During the period between Visits 1 and 2, had any episode of severe hypoglycemia
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