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Diabetes Mellitus, Type 1Phase 2NCT02702011

Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus

A Phase 2 study testing empagliflozin medium dose, empagliflozin low dose and empagliflozin high dose in people with Diabetes Mellitus, Type 1, run by Boehringer Ingelheim at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
empagliflozin medium dose, empagliflozin low dose and empagliflozin high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
4 sitesJapan
Study dates
20 Mar 2016to 3 Oct 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated written informed consent by the date of Visit 1 (screening) in accordance with Good Clinical Practice (GCP) and local legislation
  • Japanese male or female patient receiving insulin for treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) for at least 1 year at the time of Visit 1 (screening).
  • Fasting C-peptide value of < 0.6 ng/mL at Visit 2 (placebo run-in) measured by the central laboratory
  • Use of, and be willing, based on the investigator's judgment, to continue throughout the duration of the trial Multiple daily injection(MDI) of insulin consisting of at least 1 basal insulin injection and at least 3 daily bolus injections The total daily insulin dose must be>=0.3 U/kg and <=1.5 U/kg at Visit 1 (screening)
  • HbA1c of 7.5% to 10.0% at Visit 1 (screening) measured by the central laboratory and provided that the patients HbA1c does not increase by > 0.5% within 3 months before Visit 1 (screening)
  • Based on the investigator's judgment, patient must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed at Visits 1 to 3 and just before randomization)
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  • patient-led management and adjustment of insulin therapy
  • reliable approach to insulin dose adjustment for meals, such as carbohydrate counting
  • reliable and regular home-based blood glucose monitoring
  • recognize the symptoms of DKA (Diabetic Ketoacidosis), and reliably monitor for ketones
  • implementation of an established "sick day" management regimen
  • Age >=20 years and <=65 years at Visit 1 (screening)
  • Body mass index (BMI) >=18.5 kg/m2 and<=35.0 kg/m2 at Visit 1 (screening)
  • Estimated glomerular filtration rate (eGFR) >=60 mL/min/1.73m² and <=150 mL/min/1.73m² as calculated by Japanese equation based on creatinine measured by the central laboratory at Visit 1 (screening)
  • Compliance with trial drug administration must be between 80% and 120% during the placebo run-in period, to be judged at Visit 4 and before randomization

Who cannot join

  • History of T2DM (Type 2 Diabetes Mellitus), maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
  • Pancreas, pancreatic islet cells or renal transplant recipient
  • T1DM treatment with any other anti-hyperglycaemic drug (e.g., metformin, alpha-glycosidase inhibitors, glucagon-like-peptide 1 (GLP-1) receptor agonists, SGLT-2 (Sodium-Glucose co-transporter-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins, etc.) within 3 months except subcutaneous basal and bolus insulin before Visit 1 (screening) or any history of clinically relevant hypersensitivity according to the investigator's judgment
  • Occurrence of severe hypoglycemia involving coma and/or seizure that required hospitalization or hypoglycemia-related treatment by an emergency physician or paramedic within 3 months before Visit 1 (screening)
  • Occurrence of DKA within 3 months before Visit 1 (screening) and until randomization at Visit 4 (Day 1)
  • Irregular sleep/wake cycle (e.g., patients who habitually sleep during the day and work during the night) based on the investigator's judgment
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  • Acute coronary syndrome (non-STEMI, STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months before Visit 1 (screening)
  • Diagnosis of severe gastro paresis based on investigator's judgment
  • Diagnosis of brittle diabetes based on the investigator's judgment
  • Indication of liver impairment, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) at Visit 1 (screening) as measured by the central laboratory
  • Eating disorders such as bulimia or anorexia nervosa
  • Treatment with anti-obesity drugs (e.g., Mazindol), surgery or aggressive diet regimen leading to unstable body weight (based on the investigator's judgment) 3 months before Visit 1 (screening) and until randomization
  • Treatment with systemic corticosteroids or planned initiation of such therapy at Visit 1 (screening). Inhaled use of corticosteroids (e.g., for asthma/chronic obstructive pulmonary disease) is acceptable
  • Change in dose of thyroid hormones within 6 weeks before Visit 1 (screening) or planned change or initiation of such a therapy at Visit 1 (screening)
  • Medical history of cancer or treatment for cancer in the last 5 years before Visit 1 (screening). Resected basal cell carcinoma considered cured is exempted
  • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at Visit 1 (screening)
  • Pre-menopausal women (last menstruation <=1 year before informed consent) who:
  • are nursing or pregnant or
  • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, intra uterine devices/systems, oral contraceptives, complete sexual abstinence, double barrier method and vasectomized partner
  • Alcohol or drug abuse within 3 months before Visit 1 (screening) that would interfere with trial participation based on the investigator's judgment
  • Intake of an investigational drug in another trial within 30 days before Visit 1 (screening)
  • Patient not able to understand and comply with study requirements based on the investigator's judgment
  • Any other clinical condition that, based on investigator's judgment, would jeopardise patient safety or would affect the study outcome (e.g. immunocompromised patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, etc.) during trial participation

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Souseikai Hakata Clinic

    Fukuoka, Fukuoka, 812-0025

  • Nishikumamoto Hospital

    Kumamoto, Kumamoto, 861-4157

  • Shinjuku Research Park Clinic

    Tokyo, Shinjyuku-ku, 169-0073

  • SOUSEIKAI Sumida Hospital

    Tokyo, Sumida-ku, 130-0004

Other trials in Japan

About this study

Official title: A Phase II, Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy for 28 Days in Japanese Patients With Type 1 Diabetes Mellitus

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.

Being tested
empagliflozin medium dose, empagliflozin low dose, empagliflozin high dose, placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • empagliflozin medium doseDrug

  • empagliflozin low doseDrug

  • empagliflozin high doseDrug

  • placeboDrug

Study groups in NCT02702011
Study groupRoleWhat they receive
empagliflozin low doseExperimentalNot described
Receives: Drug: empagliflozin low dose
empagliflozin medium doseExperimentalNot described
Receives: Drug: empagliflozin medium dose
empagliflozin high doseExperimentalNot described
Receives: Drug: empagliflozin high dose
placeboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in 24 Hour UGE on Day 7

    Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.

    Measured: Baseline and 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study start20 Mar 2016
  3. Primary completion5 Sep 2016
  4. Study completion3 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02702011
Sponsor's protocol ID
1245.113
Status last verified
Sep 2017
First submitted
3 Mar 2016
Last updated
2 Apr 2018

Publications

  • Shimada A, Hanafusa T, Yasui A, Lee G, Taneda Y, Sarashina A, Shiki K, George J, Soleymanlou N, Marquard J. Empagliflozin as adjunct to insulin in Japanese participants with type 1 diabetes: Results of a 4-week, double-blind, randomized, placebo-controlled phase 2 trial. Diabetes Obes Metab. 2018 Sep;20(9):2190-2199. doi: 10.1111/dom.13351. Epub 2018 Jun 5.

    PubMed 29766633

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing empagliflozin medium dose, empagliflozin low dose and empagliflozin high dose in people with Diabetes Mellitus, Type 1, run by Boehringer Ingelheim at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 24 Hour UGE on Day 7 (time frame: Baseline and 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02702011, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.

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