NCT01824264撤回2 期
A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Evaluate Change in HbA1c After 12 Weeks Monotherapy With 7 Doses of LIK066 Compared With Placebo or Sitagliptin in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks
研究概览
简要总结
The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of T2DM by standard criteria
- •Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
- •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
- •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)
- •HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients
- •HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy
- •HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients
- •Age: ≥18 and ≤ 75 years old at Visit 1
- •BMI ≥22 to ≤45 kg/m2 at Visit 1
排除标准
- •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
- •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
- •History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
- •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
- •ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >470 msec for women
- •History of malignancy
- •Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LIK066 2.5 mg
Experimental
Patients receive 2.5 mg of LIK066 once daily for 12 weeks
干预措施: LIK066 (Drug)
LIK066 5 mg
Experimental
Patients receive 5 mg of LIK066 once daily for 12 weeks
干预措施: LIK066 (Drug)
LIK066 10 mg
Experimental
Patients receive 10 mg of LIK066 once daily for 12 weeks
干预措施: LIK066 (Drug)
LIK066 25 mg
Experimental
Patients receive 25 mg of LIK066 once daily for 12 weeks
干预措施: LIK066 (Drug)
LIK066 50 mg
Experimental
Patients receive 50 mg of LIK066 once daily for 12 weeks
干预措施: LIK066 (Drug)
LIK066 100 mg
Experimental
Patients receive 100 mg of LIK066 once daily for 12 weeks
干预措施: LIK066 (Drug)
LIK066 150 mg
Experimental
Patients receive 150 mg of LIK066 once daily for 12 weeks
干预措施: LIK066 (Drug)
Sitagliptin 100 mg
Active Comparator
Patients receive 100 mg sitagliptin once daily for 12 weeks
干预措施: Sitagliptin (Drug)
Placebo
Placebo Comparator
Patients receive placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks
时间窗: baseline, 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo
次要结局
- Change from baseline in Fasting Plasma Glucose(baseline, 12 weeks)
- Change from baseline in urinary glucose to creatinine ratio(baseline, 12 weeks)
- Change from baseline in Body weight(baseline, 12 weeks)
- Change from baseline in Blood pressure(baseline, 12 weeks)
- Change from baseline in postprandial glucose during a meal test(baseline, 12 weeks)
- Change from baseline in beta cell function during a meal test(baseline, 12 weeks)
- Change from baseline in insulin secretion relative to glucose during a meal test(baseline, 12 weeks)
- Change from baseline in oral glucose insulin sensitivity during a meal test(baseline, 12 weeks)
- Change from baseline in glucagon-like peptide response during a meal test(baseline, 12 weeks)
- Change from baseline in Peptide YY response during a meal test(baseline, 12 weeks)
- Number of patients with adverse events to assess safety and tolerability of LIK066(12 weeks)
- Change from baseline in renal threshold for glucose excretion(baseline, 12 weeks)
研究者
相似试验
已完成
2 期
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With ObesityObesityNCT03320941Novartis Pharmaceuticals126
终止
2 期
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative ColitisColitis, UlcerativeNCT04074590Novartis Pharmaceuticals23
已完成
2 期
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary SyndromePolycystic Ovary SyndromeNCT03152591Novartis Pharmaceuticals29
已完成
1 期
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)Type 2 Diabetes Mellitus (T2DM)NCT01407003Novartis Pharmaceuticals138
终止
4 期
A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic DisorderPanic DisorderNCT00635076Pfizer's Upjohn has merged with Mylan to form Viatris Inc.3