A 24 Weeks, Randomized, 2 Arms, Controlled, Multi-centre, National, Open-labeled, Parallel Study in Insulin naïve Patients With Type 2 Diabetes to Compare a Lantus Titration Algorithm vs. Physician's Standard Practice
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Mean difference in HbA1c (efficacy)
研究概览
简要总结
To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.
To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.
To compare the percentage of patients achieving HbA1c< 7% in each treatment group.
To compare hypoglycaemic events (minor, severe and nocturnal) between groups.
To compare average insulin dose between groups.
To compare PRO (patients' reported outcomes) between groups.
To compare mean changes in body weight between treatment groups.
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
- None
入排标准
- 年龄范围
- 21 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes.
- •Patients in treatment with OADs (one or more) for at least 1 year who failed metabolic control (HbA1c > 8% and < 11%).
- •FBG > 130 mg/dl and < 240 mg/dl.
- •BMI < 40 kg/m2 and >25 kg/m
- •Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.
排除标准
- •C peptide < 0.30 nmol/l.
- •Unexplained weight loss of more than 10% of body weight in the last 6 months.
- •Pregnant women or women with the intention of becoming pregnant.
- •Women with childbearing potential who will not use contraceptive protection.
- •Breastfeeding women.
- •Patients using or that have used rapid or ultra-rapid acting insulins; except for those patients that have used rapid or ultra-rapid insulins during intercurrences such as AMI, severe infection or surgery.
- •Renal impairment defined as serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men.
- •Hepatic impairment defined as GPT or GOT above 2x the normal threshold.
- •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (non selective beta blockers and systemic corticosteroids).
- •History of drug or alcoholic abuse.
- •Diabetic retinopathy with surgical treatment in the 3 months prior to study entry or which may require surgical treatment within 6 months of study entry.
- •Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological, oncologic or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, at the discretion of the investigator.
- •Evidence of an uncooperative attitude, including poor compliance to any anti- diabetic treatment.
- •Known hypersensitivity to insulin glargine.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
研究组 & 干预措施
A
This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.
干预措施: Insulin Glargine (Drug)
B
This is the control group, following the physician's standard practice.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Mean difference in HbA1c (efficacy)
时间窗: 6 months
次要结局
- Minor, severe and nocturnal Hypoglycaemic events (safety)(from the begining of the treatment up to 5 days after the end of the study)