A Phase 2 Open Label Study of Magnesium L-Lactate Dihydrate (MLD10) 10 mEq Extended-Release Caplets Administered BID for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus Followed by a Blinded Random Off Phase
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Change in Serum Magnesium Concentration
研究概览
简要总结
To determine the effect of MLD10 (magnesium L-lactate dihydrate extended-release caplets) 10 mEq BID on serum magnesium in Type 2 diabetic patients with hypomagnesemia.
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)
盲法说明
The second phase of the study where subjects are randomized to either active or placebo will be blinded to both participant and investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and males with Type 2 diabetes mellitus
- •Body Mass Index between 18 to 40 kg/m2, inclusive, at Screening
- •Hypomagnesemia defined as serum magnesium ≤ 1.5 mg/dL at Screening
- •Females must be non-pregnant, non-lactating, and have a negative serum pregnancy test before enrollment.
排除标准
- •History of clinically significant GI, renal, hepatic, neurologic, hematologic, endocrine other than Type 2 diabetes mellitus, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
研究组 & 干预措施
Open label phase
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.
干预措施: Magnesium L-lactate dihydrate (Drug)
Random off phase
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo
干预措施: Magnesium L-lactate dihydrate (Drug)
Random off phase
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in Serum Magnesium Concentration
时间窗: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change from baseline in serum magnesium concentration.
次要结局
- Change in Serum Magnesium Concentration.(At 1 and 2 months after the initiation of treatment.)
- Change in Insulin Sensitivity(Three months after the initiation of treatment and then at 3 months after the start of the random off phase.)
- Change in Insulin Resistance(Three months after the initiation of treatment and then at 3 months after the start of the random off phase.)
- Change in HbA1c(Three months after the initiation of treatment and then at 3 months after the start of the random off phase.)
- Change in Fasting Blood Glucose(Three months after the initiation of treatment and then at 3 months after the start of the random off phase.)