Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

NCT01193218 | Completed Phase 2 Results

• 1 other identifier: 1245.38
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 32

Brief Summary

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c After 12 Weeks of Treatment.

  The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.

  baseline and 12 weeks

Secondary Outcomes (2)

• Occurrence of Treat to Target Efficacy Response

  baseline and 12 weeks

• Change From Baseline in FPG

  baseline and 12 weeks

Other Outcomes (1)

• Confirmed Hypoglycaemic Adverse Events

  between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days

Study Arms (5)

BI 10773 low dose QD

EXPERIMENTAL

BI 10773 tablets low dose once a day

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

BI 10773 mid-low dose QD

EXPERIMENTAL

BI 10773 tablets mid-low dose once a day

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

BI 10773 mid-high dose QD

EXPERIMENTAL

BI 10773 tablets mid-high dose once a day

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

BI 10773 high dose QD

EXPERIMENTAL

BI 10773 tablets high dose once a day

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

Placebo

PLACEBO COMPARATOR

Placebo tablets once a day

Drug: Placebo (low dose); Drug: Placebo (high dose); Drug: Placebo (mid dose)

Interventions

Placebo (low dose) DRUG

Placebo tablets once a day

Placebo

Placebo (mid dose) DRUG

Placebo tablets once a day

BI 10773 low dose QD

Placebo (high dose) DRUG

Placebo tablets once a day

BI 10773 low dose QD

BI 10773 DRUG

BI 10773 tablets low dose once a day

BI 10773 low dose QD

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus prior to informed consent
• Male and female patients on diet and exercise regimen who are:
• drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
• pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
• HbA1c at Visit 1a:
• for patients who are drug naïve: HbA1c \>=7.0 to =\<10.0%
• for patients treated with one oral antidiabetic drug: HbA1c \>=6.5 to =\<9.0%
• HbA1c of \>=7.0% and =\<10% at Visit 2 (start of run-in)

You may not qualify if:

• Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
• Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
• Impaired renal function, defined as calculated eGFR \<60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
• Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
• Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
• Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (32)

1245.38.016 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1245.38.001 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1245.38.003 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1245.38.002 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, Japan

Location

1245.38.010 Boehringer Ingelheim Investigational Site

Hanamaki, Iwate, Japan

Location

1245.38.005 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, Japan

Location

1245.38.020 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, Japan

Location

1245.38.013 Boehringer Ingelheim Investigational Site

Kashiwa, Chiba, Japan

Location

1245.38.019 Boehringer Ingelheim Investigational Site

Katsushika-ku, Tokyo, Japan

Location

1245.38.021 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

1245.38.024 Boehringer Ingelheim Investigational Site

Matsuyama, Ehime, Japan

Location

1245.38.004 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, Japan

Location

1245.38.011 Boehringer Ingelheim Investigational Site

Moriya, Ibaraki, Japan

Location

1245.38.030 Boehringer Ingelheim Investigational Site

Naha, Okinawa, Japan

Location

1245.38.032 Boehringer Ingelheim Investigational Site

Okawa, Fukuoka, Japan

Location

1245.38.031 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, Japan

Location

1245.38.025 Boehringer Ingelheim Investigational Site

Saga, Saga, Japan

Location

1245.38.014 Boehringer Ingelheim Investigational Site

Saitama, Saitama, Japan

Location

1245.38.006 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1245.38.007 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1245.38.008 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1245.38.009 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1245.38.012 Boehringer Ingelheim Investigational Site

Sasima-gun, Ibaraki, Japan

Location

1245.38.015 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1245.38.018 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1245.38.017 Boehringer Ingelheim Investigational Site

Suginami-ku, Tokyo, Japan

Location

1245.38.022 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1245.38.023 Boehringer Ingelheim Investigational Site

Ube, Yamaguchi, Japan

Location

1245.38.026 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, Japan

Location

1245.38.027 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, Japan

Location

1245.38.028 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, Japan

Location

1245.38.029 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, Japan

Location

Related Publications (4)

• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

  PMID: 38770818 DERIVED

• 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

• Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.

  PMID: 28753486 DERIVED

• Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.

  PMID: 25845768 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

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: August 31, 2010
• First Posted: September 1, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-05

Locations

JP (32)