Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c less than 7%
研究概览
简要总结
In this study, we aim to explore the beneficial effect of early short-term (two weeks), self-titrated, basal-only insulin therapy on the degree of glycemic control over 1-year follow through a prospective cohort.
详细描述
Despite the development of new drugs and therapeutic strategies for treating type 2 diabetes mellitus (T2DM), achieving long-term glycemic control remains a challenge. Results from the United Kingdom Prospective Diabetes Study (UKPDS) suggest that deterioration of glycemic control can be largely attributed to progressive β-cell loss, irrespective of the nature of pharmacological intervention. Therefore, treatments that can preserve or improve β-cell function are of great interest in the field of T2DM therapeutics. Some studies have shown that short-term intensive insulin therapy in patients newly diagnosed with T2DM produces beneficial effects on β-cell function, glycemic control, and rate of remission within 1 year. However, these studies applied complex regimes for insulin initiations that require frequent follow-up and are difficult to accept as initial therapy for T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(must have)
- •Newly diagnosed type 2 diabetes mellitus on no glucose-lowering drugs and
- •Either hemoglobin A1c equal to or more than 9% and/or random blood glucose equal to or more than 300 mg/dl.
排除标准
- •Patients with type 1 diabetes mellitus,
- •Urine ketone dipstick + and above at baseline or anytime throughout the study.
- •Pregnancy.
- •Current or recent steroid use.
- •History of coronary heart disease and heart failure.
- •GFR less than 60 mL/min/1.73 m2.
研究组 & 干预措施
basal insulin plus glucose lowering drugs
New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl.
Agree to start basal insulin for two weeks
干预措施: Insulin Glargine 100 UNT/ML Pen Injector [Lantus] (Drug)
basal insulin plus glucose lowering drugs
New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl.
Agree to start basal insulin for two weeks
干预措施: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg (Drug)
basal insulin plus glucose lowering drugs
New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl.
Agree to start basal insulin for two weeks
干预措施: Pioglitazone 30mg (Drug)
glucose lowering drugs only
New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl.
Refuse to start basal insulin.
干预措施: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg (Drug)
glucose lowering drugs only
New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl.
Refuse to start basal insulin.
干预措施: Pioglitazone 30mg (Drug)
结局指标
主要结局
Hemoglobin A1c less than 7%
时间窗: twelve months
Percentage of patients with hemoglobin A1c of less than 7%
Change in hemoglobin A1c
时间窗: twelve months
mean change in hemoglobin A1c
次要结局
- Hypoglycemia(two weeks)
研究者
Haider Ayad Alidrisi
Assistant professor
University of Basrah