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

NCT00885118 | Completed Phase 2 Results

• 1 other identifier: 1245.15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Urine Glucose Excretion

  Change from baseline in Urine glucose excretion to 28 days

  baseline and 28 days

• Change From Baseline in Fasting Plasma Glucose

  Change from baseline in Fasting plasma glucose to 28 days

  baseline and 28 days

• Change From Baseline in 8-point Glucose

  Change from baseline in 8-point glucose to 27 days

  baseline and 27 days

Secondary Outcomes (27)

• Change From Baseline in HbA1c

  baseline and 28 days

• Change From Baseline in Fructosamine

  baseline and 28 days

• Change From Baseline in 1,5-anhydroglucitol

  baseline and 28 days

• Change From Baseline in Fasting Insulin

  baseline and 28 days

• Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

  baseline and 28 days

Study Arms (5)

BI 10773 low dose quaque die (QD)

EXPERIMENTAL

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

Drug: BI 10773; Drug: Placebo (low dose)

BI 10773 mid-low dose QD

EXPERIMENTAL

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

Drug: Placebo (middle dose); Drug: BI 10773

BI 10773 mid-high dose QD

EXPERIMENTAL

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

Drug: BI 10773

BI 10773 high dose QD

EXPERIMENTAL

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

Drug: BI 10773; Drug: Placebo (high dose)

Placebo

PLACEBO COMPARATOR

patient to receive two tablets of placebo once daily

Drug: Placebo

Interventions

Placebo (middle dose) DRUG

Placebo tablets once a day

BI 10773 mid-low dose QD

Placebo DRUG

Placebo tablets once a day

Placebo

BI 10773 DRUG

BI 10773 middle dose tablets once a day

BI 10773 mid-high dose QD

Placebo (high dose) DRUG

Placebo tablets once a day

BI 10773 high dose QD

Placebo (low dose) DRUG

Placebo tablets once a day

BI 10773 low dose quaque die (QD)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
• 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%.
• Age between 20 and 70 years
• Body mass index (BMI) between18.0 and 40.0 kg/m2
• Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

You may not qualify if:

• 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
• 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.
• Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

1245.15.003 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, Japan

Location

1245.15.002 Boehringer Ingelheim Investigational Site

Koganei, Tokyo, Japan

Location

1245.15.001 Boehringer Ingelheim Investigational Site

Nakano-ku, Tokyo, Japan

Location

1245.15.005 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1245.15.004 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

Related Publications (4)

• 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.

  PMID: 35472672 DERIVED

• 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.

  PMID: 29488164 DERIVED

• 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.

  PMID: 24843716 DERIVED

• 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.

  PMID: 23940010 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2009
• Last Updated: November 25, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-11

Locations

JP (5)