NCT00701831已完成4 期
Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- HbA1c, FBG
研究概览
简要总结
Primary objective:
- To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients
Secondary objectives:
- To assess the forced titration on physician and patient satisfaction
- To evaluate the impact of training tools by means of patient profile
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2 insulin naïve patients
- •Patients whom their physician is considering initiation of Lantus treatment
- •Poor glycemic control 7,5 %10 %
- •T2 treatment with OADs more than 3 months
- •BMI<40 kg/m2
排除标准
- •Impaired renal function (Cr>2mg/dl or current renal dialysis)
- •Acute or chronic metabolic acidosis
- •Active liver disease or serum ALT or AST >2,5 than normal
- •History of hypoglycemia unawareness
- •Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
- •Pregnancy, breast feeding
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Insulin glargine
干预措施: Insulin glargine (Drug)
结局指标
主要结局
HbA1c, FBG
时间窗: after treatment end (6 months)
Final dose
时间窗: after treatment end (6 months)
Number of dose adjustment
时间窗: after treatment end (6 months)
Time to dose titration
时间窗: after treatment end (6 months)
次要结局
- Hypoglycemia(after treatment end (6 months))
- Noctural hypoglycemia(after treatment end (6 months))
- DTSQ(after treatment end (6 months))
- Physician Satisfaction Questionnaire(after treatment end (6 months))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes PatientsType 1 DiabetesNCT01978704Federico II University9
已完成
4 期
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 DiabetesDiabetes Mellitus, Type 2NCT03509324Sun Yat-sen University67
已完成
不适用
Optimal glycaemic targets for women with gestational diabetes: the randomised trial - TARGETGestational Diabetes MellitusReproductive Health and Childbirth - Fetal medicine and complications of pregnancyMetabolic and Endocrine - DiabetesACTRN12615000282583niversity of Auckland, Research Office1,100
终止
3 期
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)LymphomaLeukemiaNCT00500240M.D. Anderson Cancer Center52
已完成
不适用
A Pilot Study Examining a Reinforcement Approach to Improve Diabetes ManagementType 1 DiabetesNCT01829555UConn Health10