A Randomized, Double-blind, Parallel-group, Placebo and Active Comparator (Pioglitazone)-Controlled Clinical Study to Determine the Efficacy and Safety of Balaglitazone in Patients With Type 2 Diabetes on Stable Insulin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters.
研究概览
简要总结
Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose compared to placebo, but with less impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.
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
- •Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months
- •Age ≥ 18 years
- •BMI ≥ 25.0 kg/m2
- •HbA1c ≥ 7.0 %
- •Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days
排除标准
- •Prior or current use of any PPAR-γ agonist
- •Recent use (< 3 months) of an investigational drug
- •Pre-existing medical condition judged to preclude safe participation in the study
- •Contraindication/intolerance to study medication
- •Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
- •Diagnosed or receiving medication for heart failure, NYHA I to IV
- •Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention
- •Uncontrolled treated/untreated systolic blood pressure >180 mmHg and/or diastolic blood pressure > 95 mmHg
- •Known diabetic macular oedema
- •Serum creatinine >130 μmol/l
- •ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal
- •Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay
- •Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)
- •Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation
- •Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols
- •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
研究组 & 干预措施
Balaglitazone 10 mg per day
干预措施: Balaglitazone (Drug)
Balaglitazone 20 mg per day
干预措施: Balaglitazone (Drug)
Pioglitazone 45 mg per day
干预措施: Balaglitazone (Drug)
Placebo
干预措施: Balaglitazone (Drug)
结局指标
主要结局
HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters.
时间窗: baseline, 4, 8, 12, 17, 21 and 26 weeks
次要结局
- Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin(baseline and 26 weeks)