NCT01867307

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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

May 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 11, 2017

Completed
Last Updated

May 11, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

May 21, 2013

Results QC Date

March 31, 2017

Last Update Submit

March 31, 2017

Conditions

Diabetes Mellitus, Type 2Healthy

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)

    Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Day 14). Per-protocol set (PPS): PPS consisted of all subjects and patients in the TS who completed the treatment day 14 clamping study without any relevant deviations either in their treatment regimen or in the performance and timing of the measurements.

    Baseline and Day 14

Study Arms (2)

Healthy Controls

EXPERIMENTAL

healthy controls

Drug: BI 10773

Patients

EXPERIMENTAL

patients with type 2 diabetes mellitus

Drug: Empagliflozin

Interventions

EmpagliflozinDRUG
Patients
BI 10773DRUG

open label

Healthy Controls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with type 1 diabetes mellitus.
  • Patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater than 240 mg/dl after an overnight fast.
  • 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.
  • Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

Related Publications (2)

  • Abdul-Ghani M, Al Jobori H, Daniele G, Adams J, Cersosimo E, Triplitt C, DeFronzo RA. Inhibition of Renal Sodium-Glucose Cotransport With Empagliflozin Lowers Fasting Plasma Glucose and Improves beta-Cell Function in Subjects With Impaired Fasting Glucose. Diabetes. 2017 Sep;66(9):2495-2502. doi: 10.2337/db17-0055. Epub 2017 Jun 13.

    PMID: 28611037DERIVED

  • Al-Jobori H, Daniele G, Cersosimo E, Triplitt C, Mehta R, Norton L, DeFronzo RA, Abdul-Ghani M. Empagliflozin and Kinetics of Renal Glucose Transport in Healthy Individuals and Individuals With Type 2 Diabetes. Diabetes. 2017 Jul;66(7):1999-2006. doi: 10.2337/db17-0100. Epub 2017 Apr 20.

    PMID: 28428225DERIVED

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

Study Record Dates

First Submitted

May 21, 2013

First Posted

June 4, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 11, 2017

Results First Posted

May 11, 2017

Record last verified: 2017-03

Locations

US(1)