NCT01907854已完成4 期
Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •- Subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose
- •- HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
- •- Body mass index equal to or above 20 kg/m^2
排除标准
- •- Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
- •- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
- •- Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
- •- History of chronic pancreatitis or idiopathic acute pancreatitis
- •- Screening calcitonin value equal to or above 50 ng/L
- •- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
- •- Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
- •- Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m^2 per modification of diet in renal disease formula
- •- Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
- •- Heart failure, New York Heart Association class IV
- •- Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
研究组 & 干预措施
Liraglutide + metformin + sitagliptin placebo
Experimental
干预措施: placebo (Drug)
Liraglutide + metformin + sitagliptin placebo
Experimental
干预措施: liraglutide (Drug)
Sitagliptin + metformin + liraglutide placebo
Experimental
干预措施: sitagliptin (Drug)
Sitagliptin + metformin + liraglutide placebo
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Haemoglobin)
时间窗: From baseline to week 26
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).
次要结局
- Change in Body Weight(From baseline to week 26)
- Change in Fasting Plasma Glucose(From baseline to week 26)
- Change in Fasting Blood Lipids(From baseline to week 26)
- Change in Systolic Blood Pressure and Diastolic Blood Pressure(From baseline to week 26)
- Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)(After 26 weeks of treatment)
- Number of Treatment Emergent Adverse Events (TEAEs)(During 26 weeks of treatment plus one week follow-up period.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia ACongenital Bleeding DisorderHaemophilia ANCT02994407Novo Nordisk A/S50
已完成
3 期
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT00700817Novo Nordisk A/S665
已完成
3 期
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes MellitusDiabetesDiabetes Mellitus, Type 1NCT01835431Novo Nordisk A/S362
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT03086330Novo Nordisk A/S302
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT02305381Novo Nordisk A/S397