NCT01794143已完成3 期
Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study
GRADE Study Group36 个研究点 分布在 1 个国家目标入组 7,850 人开始时间: 2013年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7,850
- 试验地点
- 36
- 主要终点
- Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
研究概览
简要总结
The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women diagnosed with diabetes at age ≥ 30 years (≥ 20 for American Indians)
- •Duration of diagnosed diabetes < 10 years
- •HbA1c criteria (at final run-in visit, ~2 weeks prior to randomization): 6.8-8.5%
- •Taking a daily dose of ≥ 1000 mg metformin for a minimum of 8 weeks at final run-in
- •Willingness to administer daily subcutaneous injections, take a second diabetes drug after randomization, potentially initiate insulin and intensify insulin therapy if study metabolic goals are not met, perform self-monitoring of blood glucose
- •Fluent in either English or Spanish
- •A negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile)
- •Provision of signed and dated informed consent prior to any study procedures
排除标准
- •Suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin) or "secondary" diabetes due to specific causes (e.g. previously diagnosed monogenic syndromes, pancreatic surgery, pancreatitis)
- •Current or previous (within past 6 months) treatment with any diabetes drug/glucose-lowering medication other than metformin (limited use of no longer than seven days is allowed, for example during hospitalization)
- •More than 10 years of treatment with metformin at time of randomization screening
- •History of intolerance or allergy or other contraindications to any of the proposed study medications
- •Resides in the same household with another GRADE study participant
- •Current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome
- •Symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician
- •A life-threatening event within 30 days prior to screening or currently planned major surgery
- •Any major cardiovascular event in previous year, including history of myocardial infarction, stroke, or vascular procedure such as coronary artery or peripheral bypass grafting, stent placements (peripheral or coronary) or angioplasty.
- •Plans for pregnancy during the course of the study for women of child-bearing potential
- •History of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass (if banding removed, may be considered eligible after 1 year)
- •History of congestive heart failure (NYHA 3 or greater)
- •History of pancreatitis
- •History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization
- •Personal or family history of MEN-2 or family history of medullary thyroid cancer
- •Estimated GFR (eGFR) <30 ml/min/1.73 m2 or end stage renal disease requiring renal replacement therapy
- •History of severe liver disease or acute hepatitis or ALT > 3 times upper limit of normal
- •Current alcoholism or excessive alcohol intake
- •Previous organ transplant
- •Treatment with oral or systemic glucocorticoids (other than short-term treatment, for example for poison ivy) or disease likely to require periodic or regular glucocorticoid therapy (inhaled steroids are allowed)
- •Treatment with atypical antipsychotics
- •History of hemolytic anemia, chronic transfusion requirement, or other condition rendering HbA1c results unreliable as indicator of chronic glucose levels, or hematocrit <35 for males and <33 for females
- •Clinically or medically unstable with expected survival <1 year
- •Unwillingness to permit sites to contact the PCP to communicate information about the study and the participant's data
- •No non-study PCP or inability to identify such a PCP (who will provide non-study care) by the time of final run-in
- •Participation in another interventional clinical trial
- •Previous randomization in the GRADE study
- •In the opinion of the principal investigator (PI), any other factor, including language barrier, likely to limit compliance with the protocol
研究组 & 干预措施
Sulfonylurea (glimepiride)
Active Comparator
Sulfonylurea
干预措施: Sulfonylurea (glimepiride) (Drug)
DPP-4 inhibitor
Active Comparator
DPP-4 inhibitor (sitagliptin)
干预措施: DPP-4 inhibitor (sitagliptin) (Drug)
GLP-1 receptor agonist
Active Comparator
GLP-1 receptor agonist (liraglutide)
干预措施: GLP-1 receptor agonist (liraglutide) (Drug)
Insulin (glargine)
Active Comparator
Insulin (glargine), Lantus
干预措施: Insulin (glargine) (Drug)
结局指标
主要结局
Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
时间窗: Quarterly for 4 to 7 years
The primary metabolic outcome is the time to primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline.
HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
时间窗: Quarterly, 4-7 years
Number of participants who reached primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline.
次要结局
- Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.(Quarterly, 4-6 years)
- HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.(Quarterly for 4 to 7 years)
研究者
研究点 (36)
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