MedDataX Logo

4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

NCT ID: NCT00885118

Last Updated: 2014-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BI 10773 low dose quaque die (QD)

patient to receive a BI 10773 low dose tablet and a placebo tablet once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 low dose tablets once a day

Placebo (low dose)

Intervention Type DRUG

Placebo tablets once a day

BI 10773 mid-low dose QD

patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily

Group Type EXPERIMENTAL

Placebo (middle dose)

Intervention Type DRUG

Placebo tablets once a day

BI 10773

Intervention Type DRUG

BI 10773 middle dose tablets once a day

BI 10773 mid-high dose QD

patient to receive two tablets of BI 10773 middle dose once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 middle dose tablets once a day

BI 10773 high dose QD

patient to receive a BI 10773 high dose tablet and a placebo tablet once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 high dose tablets once a day

Placebo (high dose)

Intervention Type DRUG

Placebo tablets once a day

Placebo

patient to receive two tablets of placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets once a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo (middle dose)

Placebo tablets once a day

Intervention Type DRUG

Placebo

Placebo tablets once a day

Intervention Type DRUG

BI 10773

BI 10773 middle dose tablets once a day

Intervention Type DRUG

BI 10773

BI 10773 high dose tablets once a day

Intervention Type DRUG

BI 10773

BI 10773 middle dose tablets once a day

Intervention Type DRUG

Placebo (high dose)

Placebo tablets once a day

Intervention Type DRUG

BI 10773

BI 10773 low dose tablets once a day

Intervention Type DRUG

Placebo (low dose)

Placebo tablets once a day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
2. Hemoglobin A1c (HbA1c) at screening (Visit 1)

* For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.
* For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.
3. Age between 20 and 70 years
4. Body mass index (BMI) between18.0 and 40.0 kg/m2
5. Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion Criteria

1. Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
2. Fasted blood glucose of \>240 mg/dL (\>13.3 mmol/L) or a randomly determined blood glucose level of \>400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.
3. Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
4. Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as

* Renal insufficiency (calculated estimated glomerular filtration rate \<60)
* Cardiac insufficiency of New York Heart Association (NYHA) II-IV or other known cardiovascular diseases including hypertension of \>160/95 mmHg,
* Neurological disorders (such as epilepsy) or psychiatric disorders
* Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
* Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
5. Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:

* Statins.
* Antihypertensives (diuretics not allowed)
* alpha-Blockers for benign prostate hypertrophy
* Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1245.15.003 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, , Japan

Site Status

1245.15.002 Boehringer Ingelheim Investigational Site

Koganei, Tokyo, , Japan

Site Status

1245.15.001 Boehringer Ingelheim Investigational Site

Nakano-ku, Tokyo, , Japan

Site Status

1245.15.005 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1245.15.004 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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)

Yasui A, Lee G, Hirase T, Kaneko T, Kaspers S, von Eynatten M, Okamura T. Empagliflozin Induces Transient Diuresis Without Changing Long-Term Overall Fluid Balance in Japanese Patients With Type 2 Diabetes. Diabetes Ther. 2018 Apr;9(2):863-871. doi: 10.1007/s13300-018-0385-5. Epub 2018 Feb 27.

Reference Type DERIVED
PMID: 29488164 (View on PubMed)

Kanada S, Koiwai K, Taniguchi A, Sarashina A, Seman L, Woerle HJ. Pharmacokinetics, pharmacodynamics, safety and tolerability of 4 weeks' treatment with empagliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Nov 27;4(6):613-7. doi: 10.1111/jdi.12110. Epub 2013 Jun 25.

Reference Type DERIVED
PMID: 24843716 (View on PubMed)

Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.

Reference Type DERIVED
PMID: 23940010 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1245.15

Identifier Type: -

Identifier Source: org_study_id