A randomized, placebo-controlled clinical trial of Teneligliptin as Quadruple oral combination therapy for type 2 DM after failure of an oral triple anti-diabetic regimen
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 99
研究概览
简要总结
Aim: To investigate the effectiveness and safety of teneligliptin over placebo in patients with type 2 diabetes (T2D) inadequately controlled by triple therapy. Materials and Methods: This trial was prospective, multicentre, randomized, 12-week double-blind, and placebo-controlled period. The double-blind period was followed by a 24-week open-label clinical trial. One hundred patients with T2D who failed to achieve the glycaemic target (7.1%?=?HbA1c = 9.0%) with conventional triple oral anti-diabetic agents (OADs) of metformin, sulphonylurea and sodium-glucose cotransporter-2 inhibitor (SGLT2i) were assigned randomly 1:1 into teneligliptin and placebo-teneligliptin groups. The primary endpoint was mean change in HbA1c level from baseline in each group at 12 weeks. Results: In a total of 99 patients (n= 51 for the teneligliptin group, and n=48 for the placebo-teneligliptin group), the mean age and duration of diabetes were 60.7 and 13.6 years, respectively, and HbA1c was 7.8% at baseline. At 12 weeks, the teneligliptin group achieved a significant reduction in HbA1c from baseline (-0.9 ± 0.6%, p<0.001) over placebo with an inter-group difference of -0.75% (95% CI [-0.99, -0.51], p<0.001). At the end of the 24-week treatment, both groups showed significant reductions in HbA1c level from baseline (placebo-teneligliptin group, -0.8 ± 0.6% [p<0.001], teneligliptin group, -0.9 ± 0.6% [p<0.001]), without significant inter-group difference (-0.17%, 95% CI [-0.41, 0.07], p=0.156). There was no significant difference between groups in rate of adverse events (AEs) (placebo-teneligliptin group, n = 3 [6.3%]; teneligliptin group, n = 11 [11.1%]; p=0.550), and the safety profiles was favourable in both groups. Conclusions: The current study shows that teneligliptin could be a valid option as a fourth OAD for treatment of patients with T2D inadequately controlled with a triple combination of OADs
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •1) Male or female aged 19-80 years diagnosed with T2D
- •2) T2D on stable daily 3 drugs doses for 12 weeks prior to the day of screening of teneliglipite or placebo: metformin (=1000 mg/day), sulfonylureas(=Glimepiride 4 mg/day or =Gliclazide 60 mg/day), SGLT2 inhibitors (availiable drugs in Korea)
- •3) HbA1c of 8-10.5% at the time of screening
- •4) T2D who refused insulin therpy suggested by physician
- •5) T2D who understand the protocol and fully cooperate the clinical trial until the end of the study
- •6) T2D who are vuluntarily capable of giving signed informed consent
排除标准
- •1) Have type 1 diabetes mellitus, gestational diabetes or other type of diabetes except type 2 diabetes
- •2) Have a history of insulin injection prior to screening time for more than 1 week consecutively within 1 year
- •3) Have any other condition (eg, hypersensitivity) that is a contraindication to teneligliptin main incredient
- •4) Have a history of taking any kind of DPP4 inhibitor prior to screening time within 3 monthos or severe side effects of DPP4 inhibitor
- •5) Have uncontrolled diabetes requiring immediate therapy (such as coma, acute or chronic diabetic ketoacidosis) at screening or randomization within 12 weeks, in the judgment of the physician
- •6) Have a history of genetic disease such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption
- •7) Those who could not take oral medication (orofacil abnormality or CNS disorders etc.)
- •8) Have a history of steroid (oral or non-oral route) prior to screening time for more than 14 days consecutively within 8 weeks; except for inhaltor
- •9) Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years prior to screening time
- •10) Have chronic New York Heart Association Functional Classification III CHF
- •11) Have had an MI, surgical or percutaneous coronary revascularization procedure, ischemic stroke, carotid stenting or surgical revascularization, nontraumatic amputation or peripheral vascular procedure (eg, stenting or surgical
- •revascularization) less than 24 weeks prior to screening
- •12) Those who satarted to take on stain within 4 weeks at the time of screening or are expected to increase the doses of statin during clinical trial
- •13) Have known chronic renal failure (stage 3,defined as a known CKD-EPI eGFR <30 mL/minute/1.73 m2) or are on chronic dialysis
- •14) Have acute or chronic hepatitis, signs or symptoms of any other liver disease, or an alanine aminotransferase (ALT), AST, ASL, bilirubin level =2.5X the upper limit of normal (ULN), or Child-Pugh class B or C for the reference range, as determined by the central laboratory
- •15) Have a history of HIV, HBV, HCV infection within 1 year
- •16) Women of childbearing or potential or lactation; planning pregnancy
- •17) Those who are severe infection, traumatized or planning surgery during the clinical trial (who are needed to insulin therapy)
- •18) Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder)
- •19) Have participated within the last 30 days in a clinical trial involving an investigational product
- •20) not suitable patients judged by physician