A multi-center, randomized, double-blind, double-dummy, parallel-groupdose-finding study to evaluate the change in HbA1c after 12 weeksmonotherapy with LIK066 doses ranging from 2.5mg to 150mg daily takenq.d., b.i.d., or t.i.d. compared with placebo or sitagliptin in patients withtype 2 diabetes

ovartis Pharma Services AG0 个研究点目标入组 750 人开始时间: 2013年6月6日最近更新: 2013年11月18日

研究概览

暂无简介。

•1.Confirmed diagnosis of T2DM by standard criteria
•2.Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
•3.Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1
•4.Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI)
•5.HbA1c = 7 to = 10.5% at Visit 1 for drug-naïve/currently untreated patients
•6.HbA1c = 7 to = 9.5% at Visit 1 for patients treated with OAD monotherapy
•7.HbA1c = 7 to = 10.5% at Visit 199 for ALL patients
•8.Age: =18 and = 75 years old at Visit 1
•9.BMI =22 to =45 kg/m2 at Visit 1
•Other protocol-defined inclusion criteria may apply
•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 502
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 248

•1.FPG =270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or =240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1
•2.Insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
•3.History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
•4.Significant lab abnormalities such as TSH outside of normal range, UACR>300 mg/g creatinine, eGFR <60 ml/min/1.73m2, hemoglobin <12 g/L in men and <11 g/L in women, hematuria
•5.ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >460 msec for women
•6.History of malignancy
•7.Women of child-bearing potential not using effective methods of contraception
•Other protocol-defined exclusion criteria may apply

发起方