臨床研究等提出・公開システム

A phase III, double-blind, placebo-controlled, monotherapy study of imeglimin (TIMES 1)

TIMES 1

213

Baseline characteristics were similar between treatment groups with regard to age, diabetes duration, HbA1c, BMI, and eGFR. Mean age was 62.0 years and 100 (46.9%) were elderly (=>65 years). Mean eGFR was 71.31 mL/min/1.73m2 and the majority of patients were treatment naive (71.8%).

106 and 107 patients were randomly assigned to treatment with imeglimin and placebo, respectively. Overall, 194 (91%) completed the 24-week, double-blind treatment period.

The proportion of participants reporting any adverse events was similar between groups. Most reported adverse events were of mild intensity. 47 patients (44.3%) reported =>1 adverse event in the imeglimin group versus 48 patients (44.9%) in the placebo group. Hypoglycemia events were reported in three patients (2.8%) in the imeglimin group and one patient (0.9%) in the placebo group. No episodes of severe hypoglycemia were reported. No effect was observed on blood pressure or body weight. No deaths were reported in any of the groups. A total of five patients experienced a serious adverse event during the trial: four (3.8%) in the imeglimin group and one (0.9%) in the placebo group. No patient experienced a serious adverse event considered by the investigator to be related to treatment.

Compared with placebo, the adjusted mean difference of imeglimin treatment in change from baseline HbA1c at week 24 was -0.87% (95% CI -1.04 to -0.69; P < 0.0001).

At week 24, HbA1c <7% was achieved by significantly more patients in the imeglimin group (n=38 of 106 patients [35.8%]) compared with the placebo group (n=8 of 106 patients [7.5%]; P < 0.0001).

Imeglimin significantly improved HbA1c in Japanese patients with type 2 diabetes compared with placebo and had a similar safety profile to placebo. Imeglimin represents a potential new treatment option for this population.

Feb. 11, 2021

https://care.diabetesjournals.org/content/44/4/952

No

POXEL S.A.

https://www.poxelpharma.com/en_us/contact

POXEL S.A.

https://www.poxelpharma.com/en_us/contact

completed

Dec. 26, 2017

Interventional

A randomized, double-blind, placebo-controlled, monotherapy study

treatment purpose

3

Main inclusion criteria:
1) Patients with type 2 diabetes mellitus, diagnosed for at least 12 weeks
2) Body Mass Index (BMI) >= 18.5
3) HbA1c >=7.0% and < 10.0%

Main exclusion criteria:
1) Patients with type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
2) History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
3) Cardiovascular or cerebrovascular disease within 24 weeks (myocardial infarction, stroke, unstable angina etc.)
4) Uncontrolled high blood pressure
5) Severe impairment of hepatic function

Both

Type 2 Diabetes Mellitus

investigational material(s)
Generic name etc : PXL008
INN of investigational material : Imeglimin
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : 1000 mg twice daily, oral

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Twice daily, oral

efficacy
HbA1c
To assess the change in HbA1c from baseline after 24 weeks of imeglimin treatment compared to placebo

efficacy
safety
Fasting Blood Glucose (FPG)
To assess the change in HbA1c from baseline after 24 weeks of imeglimin treatment compared to placebo

-

Nov. 17, 2017