NCT00511732已完成2 期
A Randomized, Double-blind, Controlled, Stepwise Titration Study to Evaluate Dose Response to Prandial Administration of Inhaled Technosphere/Insulin or Technosphere in Patients With Type 2 Diabetes Mellitus Who Are Sub-optimally Treated
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
- 227
- 主要终点
- HbA1c change from baseline (week 6) to end of treatment (week 17)
研究概览
简要总结
Designed to evaluate dose response of force-titrated prandial administration of TI as compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females patients from 18 to <80 years of age
- •Clinical diagnosis of type 2 diabetes mellitus
- •Duration of diabetes of >3 years and <20 years
- •Glycemic control at upper end of acceptable level or sub-optimal in control (HbA1c between 7.0% and 12?0%)
- •Confirmation of diagnosis of diabetes such as a history of 2 hour postprandial blood glucose >11.1 mmol/L (200 mg/dL) or following a glucose tolerance test
- •A minimum of 2 months of treatment with a stable dose of one or more of the following anti-hyperglycemic agents: sulphonylureas, alpha glucosidase inhibitors, metformin, meglitinides, thiazolidinediones and/or Lantus basal insulin therapy
- •FBG:>6 mmol/L (108 mg/dL)
- •C-peptide: >0.5 nmol/L
- •BMI <38 kg/m2
- •Baseline DLco, FVC, FEV1 >75% of predicted normal
- •Subjects who, in the opinion of the Investigator, will be able to complete this study
- •Written informed consent
排除标准
- •Severe complications of diabetes including history of: blindness from or grade III or IV diabetic retinopathy, renal failure requiring dialysis or transplantation, amputation of limbs or digits related to diabetic vasculopathy or foot ulcers
- •Treatment with another investigational drug within 3 months prior to study entry and for the duration of the study
- •History of drug or alcohol dependency
- •Significant hepatic disease (as evidenced by ALT or AST >3 times the normal upper reference range or bilirubin >1.5 times the normal upper reference range)
- •Significant renal disease (as evidenced by creatinine >1.5 mg/dL for males or >1.3 mg/dL for females) or proteinuria >1,000 mg/24 hours
- •History of chronic obstructive pulmonary disease, or history of other known chronic pulmonary diseases, such as reactive airway disease, chronic bronchitis, emphysema, or asthma
- •Heart disease graded as class III or class IV according to New York Heart Association criteria
- •Prior treatment with , or participation in a clinical study involving an inhaled insulin product
- •Current use of preprandial or prandially administered fast-acting or rapid acting insulin or insulin analogs
- •Previous participation in a TI or TP clinical trial
- •Allergy to insulin or to any drugs to be used as part of the clinical trial
- •History of malignancy within 5 years of study entry (other than basal cell carcinoma)
- •Anemia (hemoglobin level less than 11 g/dL for females or 12 g/dL for males at study entry)
- •Diagnosis of Acquired Immunodeficiency Syndrome (AIDS) and Aids Related Complex A major psychiatric disorder that will preclude satisfactory participation in this study
- •Subjects who have had a myocardial infarction or stroke within the preceding 6 months
- •Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
- •History of severe or multiple allergies
- •Progressive fatal disease
- •Recent loss (within the past 2 months) of >5% of body weight
- •Evidence of "moderate" or greater ketones in urine or history of ketoacidosis
- •Use of medications known to modify glucose metabolism or the ability to recover from hypoglycemia such as oral, parenteral and inhaled steroids, or greater than 25 mg hydrochlorothiazide daily
- •Women who are pregnant or lactating
- •Women of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, or surgical sterilization).
研究组 & 干预措施
Technosphere Insulin
Experimental
干预措施: Technosphere Insulin (Drug)
Technosphere Inhalation Powder
Placebo Comparator
干预措施: Technosphere Placebo (Drug)
结局指标
主要结局
HbA1c change from baseline (week 6) to end of treatment (week 17)
时间窗: measured from week 6 (baseline) to week 17
Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline.
时间窗: at weeks 4, 6, 11 and 17
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration
Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline)
时间窗: at weeks 4, 6, 11 and 17
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration
次要结局
- Fasting blood glucose concentration compared to week 6 (baseline)(at weeks 4, 6, 11 and 17)
- Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations(18 weeks)
研究者
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