NCT01511172已完成2 期
Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Fasting plasma/serum glucose
研究概览
简要总结
This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
- •Duration of type 2 diabetes diagnosis at least one year
- •HbA1c 8.0-13.0%, both inclusive
- •Body Mass Index (BMI) between 25-40 kg/m^2, both inclusive.
排除标准
- •Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
- •Impaired liver function
- •Impaired renal function
- •Cardiac problems
- •Uncontrolled treated/untreated hypertension
- •Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
- •Recurrent major hypoglycaemia as judged by the Investigator
- •Known or suspected allergy to trial product or related products
- •Use of any drug (except for OHAs), which in the Investigator's opinion could interfere with the glucose level
- •Known or suspected abuse of alcohol or narcotics
- •Any contraindications to metformin or glimepiride according to the local guidelines
研究组 & 干预措施
NNC 90-1170 + Met
Experimental
干预措施: liraglutide (Drug)
NNC 90-1170 + Met
Experimental
干预措施: metformin (Drug)
NNC 90-1170 + Met placebo
Experimental
干预措施: placebo (Drug)
Met + NNC 90-1170 placebo
Placebo Comparator
干预措施: metformin (Drug)
Met + NNC 90-1170 placebo
Placebo Comparator
干预措施: placebo (Drug)
Met + Glim
Active Comparator
干预措施: metformin (Drug)
Met + Glim
Active Comparator
干预措施: glimepiride (Drug)
结局指标
主要结局
Fasting plasma/serum glucose
次要结局
- Fructosamine
- Home monitored fasting plasma glucose
- C-peptide
- Home monitored 7-point glucose profile
- HbA1c (glycated haemoglobin A1c)
- Insulin
- Weight
- Other adverse events
- Beta-cell function and insulin resistance (HOMA model)
- Gastro-intestinal adverse events
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00184574Novo Nordisk A/S603
已完成
3 期
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT02773368Novo Nordisk A/S420
已完成
不适用
Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 DiabetesDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT00671008Novo Nordisk A/S400
已完成
不适用
Observational Study Describing Conditions for Administering Slow-acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose ControlDiabetesDiabetes Mellitus, Type 2NCT00700960Novo Nordisk A/S2,745
已完成
不适用
Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of DiabetesDiabetesDiabetes Mellitus, Type 2NCT00715351Novo Nordisk A/S342