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 regime
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0005169
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 99
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method