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Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

empagliflozin medium dose

empagliflozin high dose

empagliflozin low dose

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

empagliflozin high dose

empagliflozin medium dose

empagliflozin low dose

Arm Description

Patient to receive a high dose of empagliflozin

Patient to receive a medium dose of empagliflozin

Patient to receive a low dose of empagliflozin

Outcomes

Primary Outcome Measures

AUC0-inf

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

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).

Cmax

Maximum measured concentration in plasma (Cmax).

Tmax

Maximum measured concentration in plasma (tmax).

t1/2

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

Secondary Outcome Measures

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

Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake. For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'UGE at baseline' and 'FPG at baseline' as continuous covariates. Means presented are the adjusted means.

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

Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake. For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'FPG at baseline' as continuous covariate. Means presented are the adjusted means.

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

Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1). For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as fixed effect and 'MDG at baseline' as continuous covariate. Means presented are the adjusted means.

Full Information

NCT ID

NCT02121483

First Posted

April 22, 2014

Last Updated

July 28, 2016

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02121483

Brief Title

Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus

Official Title

An Open-label, Randomised, Multicentre, Single-dose, Parallel Group Trial to Evaluate Pharmacokinetics and Pharmacodynamics of Empagliflozin in Children and Adolescents From 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

empagliflozin high dose

Arm Type

Experimental

Arm Description

Patient to receive a high dose of empagliflozin

Arm Title

empagliflozin medium dose

Arm Type

Experimental

Arm Description

Patient to receive a medium dose of empagliflozin

Arm Title

empagliflozin low dose

Arm Type

Experimental

Arm Description

Patient to receive a low dose of empagliflozin

Intervention Type

Drug

Intervention Name(s)

empagliflozin medium dose

Intervention Type

Drug

Intervention Name(s)

empagliflozin high dose

Intervention Type

Drug

Intervention Name(s)

empagliflozin low dose

Primary Outcome Measure Information:

Title

AUC0-inf

Description

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

Time Frame