Clinical trial NCT01947855: Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, 4-week Study to Evaluate the Efficacy of Empagliflozin (10 mg and 25 mg Administered Orally Once Daily) in Postprandial Glucose and 24-hour Glucose Variability in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2013-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.


Eligibility criteria: Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus prior to informed consent
* Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:

  * drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
  * pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.)
* Glycosylated haemoglobin (HbA1c) at Visit 1 (screening)

  * for patients without antidiabetic therapy : HbA1c \>=7.0 to =\<10.0%
  * for patients with one oral antidiabetic drug : HbA1c \>=7.0 to =\<9.5%

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13.3 mmol/L)
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula)
* Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Primary outcomes:
measure: Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment
timeFrame: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Shinjyuku-ku, Tokyo
country: Japan
facility: 1245.35.002 Boehringer Ingelheim Investigational Site
city: Suita-shi, Osaka
country: Japan
facility: 1245.35.001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
citation: Nishimura R, Tanaka Y, Koiwai K, Ishida K, Salsali A, Kaspers S, Kohler S, Lund SS. Effect of Empagliflozin on Free Fatty Acids and Ketone Bodies in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. Adv Ther. 2019 Oct;36(10):2769-2782. doi: 10.1007/s12325-019-01045-x. Epub 2019 Aug 23.
citation: Nishimura R, Tanaka Y, Koiwai K, Inoue K, Hach T, Salsali A, Lund SS, Broedl UC. Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study. Cardiovasc Diabetol. 2015 Jan 30;14:11. doi: 10.1186/s12933-014-0169-9.