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Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01947855

Last Updated: 2014-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Empagliflozin low dose

Empagliflozin low dose tablet once daily

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

Empagliflozin low dose

Placebo

Intervention Type DRUG

Placebo tablet matching Empagliflozin high dose

Empagliflozin high dose

Empagliflozin high dose tablet once daily

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo tablet matching Empagliflozin low dose

Empagliflozin

Intervention Type DRUG

Empagliflozin high dose tablet once daily

Placebo

Placebo tablet once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet matching Empagliflozin high dose

Placebo

Intervention Type DRUG

Placebo tablet matching Empagliflozin low dose

Interventions

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Placebo

Placebo tablet matching Empagliflozin low dose

Intervention Type DRUG

Empagliflozin

Empagliflozin low dose

Intervention Type DRUG

Placebo

Placebo tablet matching Empagliflozin high dose

Intervention Type DRUG

Placebo

Placebo tablet matching Empagliflozin low dose

Intervention Type DRUG

Empagliflozin

Empagliflozin high dose tablet once daily

Intervention Type DRUG

Placebo

Placebo tablet matching Empagliflozin high dose

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.35.002 Boehringer Ingelheim Investigational Site

Shinjyuku-ku, Tokyo, , Japan

Site Status

1245.35.001 Boehringer Ingelheim Investigational Site

Suita-shi, Osaka, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 35472672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31444706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25633683 (View on PubMed)

Other Identifiers

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1245.35

Identifier Type: -

Identifier Source: org_study_id