NCT00642538已完成1 期
A Phase 1, Repeated Single-Dose, Double Blind, Randomized, Five Treatment Controlled Safety and Pharmacological Response Evaluation Trial of MKC253 Inhalation Powder in Adult Male and Postmenopausal Female Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC 0-240 min post-prandial serum glucose
研究概览
简要总结
20 eligible subjects will be enrolled into the treatment phase of the trial.
详细描述
Trial objectives are to determine the safety & pharmacological response of MKC253 Inhalation Powder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Non-smoking males and females between 18 and 70 years of age
- •Body Mass Index (BMI) of < 32 kg/m2
- •Diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. For subjects taking both metformin and sulfonylurea or meglitinide or alpha glucosidase inhibitor, one or both oral agents must be less than 1/2 the maximal allowable dose as cited in the product label.
- •HbA1c = 6.2 to = 8.5%. Fasting C-peptide = 0.5 ng/mL. On the last 3 days of the washout period (Day -3, -2, and -1) subjects should have a FBG (finger stick) = 13.5 mmol/L.
- •Normal pulmonary function and performance on pulmonary function tests
- •Written Informed Consent
- •Treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks [ie, thiazolidinediones (TZDs), dipeptyl peptidase inhibitors (DPP-IV), Symlin (pramlintide acetate) and or Byetta (exenatide)].
排除标准
- •Exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial.
- •Use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the PI and Sponsor. The use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as co-medications is allowed throughout the study.
- •Significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC OR FEV1).
- •Serum creatinine above Upper Limit of Normal (ULN) as defined by the laboratory
- •Any other condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial.
研究组 & 干预措施
1
Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
干预措施: MKC253 Inhalation Powder (Drug)
2
Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
干预措施: MKC253 Inhalation Powder (Drug)
3
Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
干预措施: MKC253 Inhalation Powder (Drug)
4
Placebo Comparator
TIP (placebo comparison)
干预措施: Technosphere Inhalation Powder (Drug)
5
Active Comparator
10 ug subcutaneous control
干预措施: subcutaneous injection (Drug)
结局指标
主要结局
AUC 0-240 min post-prandial serum glucose
时间窗: 240 minutes
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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