NCT01498185已完成2 期
A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus
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
- 171
- 试验地点
- 12
- 主要终点
- Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7
研究概览
简要总结
To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)
详细描述
Study Classification : Safety, Pharmacokinetics and Pharmacodynamics
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes with central lab Glycosylated hemoglobin (A1C) ≥ 7.0% and ≤ 10.0%
- •Insulin use for at least 12 months and initiation immediately after diagnosis of diabetes
- •Method of Insulin administration [multiple daily injections (MDI) or continuous subcutaneous Insulin infusion (CSII)] stable ≥ 3 months
- •Stable basal Insulin dose ≥ 2 weeks
- •Ages 18 to 65 years
- •Central laboratory C-peptide value of < 0.7 ng/mL
- •Body mass index (BMI) 18.5 to 35.0 kg/m2
排除标准
- •History of type 2 diabetes mellitus (T2DM), maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
- •Oral hypoglycemic agents
- •History of diabetes ketoacidosis (DKA) within 24 weeks
- •History of hospital admission for glycemic control within 6 months
- •Frequent episodes of hypoglycemia (2 unexplained within 3 months) or hypoglycemic unawareness
- •Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or Serum total bilirubin > 2X Upper limit of normal (ULN)
- •Abnormal Free T4 [if screening Thyroid Stimulating Hormone (TSH) abnormal]
- •Estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) formula ≤ 60 mL/min/1.73m2
- •Cardiovascular (CV)/Vascular Diseases within 6 months
研究组 & 干预措施
Arm 1: Dapagliflozin (1 mg)
Experimental
干预措施: Dapagliflozin (Drug)
Arm 2: Dapagliflozin (2.5 mg)
Experimental
干预措施: Dapagliflozin (Drug)
Arm 3: Dapagliflozin (5 mg)
Experimental
干预措施: Dapagliflozin (Drug)
Arm 4: Dapagliflozin (10 mg)
Experimental
干预措施: Dapagliflozin (Drug)
Arm 5: Placebo matching Dapagliflozin
Experimental
干预措施: Placebo matching Dapagliflozin (Drug)
结局指标
主要结局
Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7
时间窗: From Baseline to Day 7
7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.
次要结局
- Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])(Day 7 (0 hr to 24 hr post dose))
- Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)(Day 7 (0 hr to 24 hr post dose))
- Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)(Day 7 (0 hr to 24 hr post dose))
- Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)(Day 7 (0 hr to 24 hr post dose))
- Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])(Day 7 (0 hr to 24 hr post dose))
- Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)(Day 7 (0 hr to 24 hr post dose))
- Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU](Day 7 (0 hr to 24 hr post dose))
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Dapagliflozin in Acute Heart FailureHeart FailureDiabetes Mellitus, Type 2NCT04298229Vanderbilt University Medical Center240
已完成
2 期
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 DiabetesType 2 Diabetes MellitusNCT00831779AstraZeneca116
已完成
3 期
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 DiabetesType 1 Diabetes MellitusNCT02268214AstraZeneca833
已完成
3 期
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 DiabetesType 1 Diabetes MellitusNCT02460978AstraZeneca815
已完成
3 期
Dapagliflozin DPPIV Inhibitor add-on StudyType 2 DiabetesNCT00984867AstraZeneca833