NCT02121483

Brief Summary

The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 19, 2016

Completed
Last Updated

September 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

April 22, 2014

Results QC Date

July 28, 2016

Last Update Submit

July 28, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

  • AUC0-inf

    Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).

    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

  • AUC0-tz

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).

    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

  • Cmax

    Maximum measured concentration in plasma (Cmax).

    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

  • Tmax

    Maximum measured concentration in plasma (tmax).

    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

  • t1/2

    Terminal half-life in plasma (t1/2).

    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

Secondary Outcomes (3)

  • Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake

    baseline and 24 hours

  • Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake

    baseline and 24 hours

  • Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake

    baseline and 24 hours

Study Arms (3)

empagliflozin high dose

EXPERIMENTAL

Patient to receive a high dose of empagliflozin

Drug: empagliflozin high dose

empagliflozin medium dose

EXPERIMENTAL

Patient to receive a medium dose of empagliflozin

Drug: empagliflozin medium dose

empagliflozin low dose

EXPERIMENTAL

Patient to receive a low dose of empagliflozin

Drug: empagliflozin low dose

Interventions

empagliflozin medium doseDRUG
empagliflozin medium dose
empagliflozin high doseDRUG
empagliflozin high dose
empagliflozin low doseDRUG
empagliflozin low dose

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents with type 2 diabetes mellitus
  • Insufficient glycaemic control (HbA1c \<=10.5%) despite diet and exercise and/or metformin and/or stable basal or MDI insulin
  • Negative for Islet Cell Antigen and Glutamic Acid Decarboxylase autoantibodies and fasting C-peptide levels \>= 0.85 ng/ml
  • BMI \> 50th percentile for age and sex

You may not qualify if:

  • Uncontrolled hyperglycaemia with a glucose level \> 240 mg/dl (\> 13.3 mmol/l)
  • History of acute metabolic decompensation such as diabetic ketoacidosis within 3 months before the screening visit with the exception of acute de-compensation at the time of type 2 diabetes diagnosis
  • Treatment with weight reduction medications within 4 weeks before randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

1245.87.01013 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

Location

1245.87.01004 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1245.87.01002 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Location

1245.87.01012 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1245.87.01001 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1245.87.33001 Boehringer Ingelheim Investigational Site

Lyon, France

Location

1245.87.97202 Boehringer Ingelheim Investigational Site

Beersheba, Israel

Location

1245.87.97203 Boehringer Ingelheim Investigational Site

Tel Litwinsky, Israel

Location

1245.87.52001 Boehringer Ingelheim Investigational Site

Chihuahua City, Mexico

Location

1245.87.27003 Boehringer Ingelheim Investigational Site

Bellville, South Africa

Location

1245.87.27002 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

Related Publications (2)

  • Bjornstad P, Laffel L, Tamborlane WV, Simons G, Hantel S, von Eynatten M, George J, Marquard J, Cherney DZI. Acute Effect of Empagliflozin on Fractional Excretion of Sodium and eGFR in Youth With Type 2 Diabetes. Diabetes Care. 2018 Aug;41(8):e129-e130. doi: 10.2337/dc18-0394. Epub 2018 Jun 25. No abstract available.

    PMID: 29941496DERIVED

  • Laffel LMB, Tamborlane WV, Yver A, Simons G, Wu J, Nock V, Hobson D, Hughan KS, Kaspers S, Marquard J. Pharmacokinetic and pharmacodynamic profile of the sodium-glucose co-transporter-2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial. Diabet Med. 2018 Aug;35(8):1096-1104. doi: 10.1111/dme.13629. Epub 2018 May 6.

    PMID: 29655290DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim (BI)
clintriage.rdg@boehringer-ingelheim.com
1800-243-0127

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 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 23, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 19, 2016

Results First Posted

September 19, 2016

Record last verified: 2016-07

Locations

US(5)IL(2)ME(1)ZA(2)FR(1)