NCT01140542已完成2 期
Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Phase IIb, Proof of Concept Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 487
- 主要终点
- Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)
研究概览
简要总结
This study is a proof of concept study to confirm in a standardized manner the therapeutic efficacy of roflumilast in type 2 diabetes mellitus patients.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •given written informed consent
- •patients with diagnosis of type 2 diabetes according to American Diabetes Association (ADA) criteria and inadequately controlled on diet and exercise alone
- •HbA1c at baseline: ≥7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania)
- •BMI between ≥26 and ≤35 kg/m2
- •willingness of patient to check his/her blood glucose with equipment provided by the sponsor during the treatment phase in case of hypo-/hyperglycemia episodes
- •willingness to adhere to the physician's advise to comply with diet and exercise
排除标准
- •patients diagnosed with type 1 diabetes or diabetes secondary to pancreatitis or resection of pancreas
- •patients diagnosed with hemoglobinopathies, hemolytic anemia or other diseases which interfere with HbA1c measurement
- •non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidism
- •reported gain or loss of more than 5 percent of body weight within the last 2 months prior to V0
- •treatment with any diabetes medication prior to V0
- •treatment with any weight-loss medication within 3 months prior to V0
- •treatment with any not allowed medication or nutrition additives
- •clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
- •clinically significant cardiac abnormalities (diagnosed clinically, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation
- •participation in a clinical study with study medication for weight loss or type 2 diabetes
- •Patients were randomized after 2 weeks of the baseline period, if the following criteria were fulfilled:
- •judged to be clinically stable
- •tablet compliance ≥80 percent and ≤125 percent
- •HbA1c in the range of 7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania) tested at V0 by the central laboratory
研究组 & 干预措施
Roflumilast
Active Comparator
500µg, once daily
干预措施: Roflumilast (Drug)
Placebo
Placebo Comparator
干预措施: Roflumilast (Drug)
结局指标
主要结局
Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)
时间窗: Baseline to last visit
次要结局
- Mean change from baseline to each scheduled post-randomization visit and Vlast based on a 5-hour period post meal area under the curve (AUC) for FFA, glycerol, glucose, glucagons, insulin, and C-peptide
- Mean change in HbA1c from baseline to each scheduled post-randomization visit
- Mean change from baseline to each scheduled post-randomization visit and Vlast in blood parameters
- Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE)
- Mean change in body weight, waist and hip circumference, waist to hip ratio, and body mass index (BMI) from baseline to each scheduled post-randomization visit and Vlast
研究者
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