CTRI/2009/091/000609已完成4 期
Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 300
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
入选标准
- •Diabetes Mellitus, Type 2
- •-Have been receiving metformin plus at least one other oral antihyperglycemic medication (sulfonylurea or TZD) without insulin, for at least 90 days prior to Visit 1
- •-HbA1c greater than or equal to 7.0% and less than 11.0%
- •regularly consume a light breakfast (less than 15% of total daily calorie intake)
- •-Capable and willing to follow the protocol
- •-Give written consent
排除标准
- •-Are taking a TZD whose country label does not allow in combination with insulin
- •-Are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
- •-Have a body mass index greater than 40 kg/m2
- •-Have a history of severe hypoglycemia in past 24 weeks
- •-Are pregnant or may become pregnant
- •-Women who are breastfeeding
- •-Have significant cardiac disease
- •-Have significant renal or liver disease
- •-Undergoing therapy for a malignancy
- •-Contraindications to study medications
- •-Have an irregular sleep/wake cycle
研究者
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