Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-10-31

Brief Summary

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Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy Controls

healthy controls

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

open label

Patients

patients with type 2 diabetes mellitus

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

Interventions

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Empagliflozin

Intervention Type DRUG

BI 10773

open label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. T2DM patients and healthy controls aged =18 to \<70 at Visit 1.
2. Patients diagnosed with T2DM according to the American Diabetes Association criteria prior to informed consent who are drug-naïve
3. T2DM patients on a stable dose of allowed concomitant medications (as determined by investigator) for 30 days prior to entering the study.
4. T2DM patients with HbA1c between \>7 and \<10.0% (\>53 mmol/mol and \<86 mmol/mol) at Visit

Exclusion Criteria

1. Patients with type 1 diabetes mellitus.
2. Patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater than 240 mg/dl after an overnight fast.
3. Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 3; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease (history of claudication), or pulmonary disease as determined by investigator.
4. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes