Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone: A Randomized Open Label Clinical Study. The MAGNNIFY Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- ΔHbA1c
研究概览
简要总结
This study will compare the effect of Dapagliflozin added to Metformin vs Metformin alone on blood sugar fluctuations of adults with a recent diagnosis of Type 2 Diabetes (T2D). The duration of the protocol will be 12 weeks. Continuous glucose monitoring will be measured before and at the end of the intervention. The questions this protocol will answer include:
- Is there a difference in blood sugar fluctuations when Dapagliflozin is added to Metformin compared with Metformin alone in adults with type 2 Diabetes?
- Does Dapagliflozin added to Metformin improve blood glucose control in patients with type 2 Diabetes?
详细描述
This is an open-label randomized clinical trial aimed to compare the effect of Dapagliflozin added to Metformin vs Metformin alone on glycemic variability of adults with a recent diagnosis of type 2 Diabetes. The central hypothesis is that the addition of Dapagliflozin will lead to a statistically significant improvement in GV parameters compared to Metformin alone. A total of 88 adults aged 18-70 years with T2DM and HbA1c between 7.5% and 12% while on a stable dose of Metformin 2000 mg/day will be enrolled. Participants will be randomized in a 1:1 ratio to one of two treatment arms for a duration of 12 weeks. The primary objective is to compare the change from baseline to end-of-treatment in key glycemic variability indices derived from continuous glucose monitoring (CGM) (Mean Amplitude Glucose Excursions -MAGE, Time in Range), changes in HbA1c, fasting blood glucose, lipid profile, BMI, blood pressure, among others.
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
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects > 18-77 years-old
- •Both Male and female
- •Hba1c ≥ 7.5 % and ≤12%
- •BMI > 25 and <45 kg/m2
- •Type 2 diabetes diagnosis, drug-naive
排除标准
- •Hba1c > 12%
- •Creatinine clearance CKD-EPI: < 60 mL/min
- •LADA or Type 1 diabetes
- •Gestational diabetes
- •Clinically significant disease like: hepatic, hematological, oncological, psychiatric or rheumatic disease.
- •Symptoms of marked uncontrolled diabetes: (marked poliuria or polidipsia + 10% weight loss prior the last 3 months enrollement)
- •Known hypersensitivity to dapagliflozin or any of the excipients of the product
- •eGFR persistently <45 mL/min/1.73 m2
- •Unstable or rapidly progressing renal disease
- •Patients with severe hepatic impairment (Child-Pugh class C)
- •Any major CV event/Vascular Disease within 3 months prior to signing the consent at enrollment, as assessed by the investigator
- •For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
结局指标
主要结局
ΔHbA1c
时间窗: 12 weeks
Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage.
ΔMAGE
时间窗: 12 weeks
● Calculation of Mean Amplitude of Glucose Excursion (MAGE): * In the first step, all local maximum/minimum values are determined. * The next step is an evaluation of maximum/minimum pairs against the standard deviation (SD). * If the difference from minimum to maximum is greater than the SD, this variation from the mean measurement is retained. * If the local maximum/minimum is less than 1 SD, it is excluded from further calculations. * These channels are retained and summed to achieve the MAGE
ΔTIR %Target 70-180 mg/dL
时间窗: 12 weeks
Time in range is defined as the percentage of time that the patient's blood glucose is between 70-180 mg/dL.
Δweight
时间窗: 12 weeks
The difference between weight before the treatment period (W0) and the end of the intervention is calculated and expressed as delta for results interpretation.
Δinsulin
时间窗: 12 weeks
Delta insulin is defined as the difference in insulin plasma concentration before treatment (W0) and at the end of the intervention (W12).
Δsystolic Blood Pressure
时间窗: 12 weeks
It is defined as the difference in systolic blood pressure before treatment (W0) and after the end of intervention (W12)
ΔTriglycerides mg/dL
时间窗: 12 weeks
It is defined as the difference in triglycerides plasma concentration before and at the end of intervention (W12-W0)
次要结局
- ΔUric Acid(12 weeks)
研究者
Miguel Ángel Gómez Sámano
Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran