A multi-center, randomized, double-blind, double-dummy, parallel-group dose-finding study to evaluate the change in HbA1c after 12 weeks monotherapy with seven doses of LIK066 compared with placebo or sitagliptin in patients with type 2 diabetes - Dose-finding study of LIK066 compared with placebo or sitagliptin to evaluate change in HbA1c

ovartis Pharma Services AG0 个研究点目标入组 491 人开始时间: 2013年4月25日最近更新: 2013年11月4日

研究概览

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•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 368
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 123

•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 >470 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