Diabetes Mellitus, Type 2Phase 2NCT01867307

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

A Phase 2 study testing Empagliflozin and BI 10773 in people with Diabetes Mellitus, Type 2 and Healthy, run by Boehringer Ingelheim at 1 site in United States.

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

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 Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2, Healthy
What is being tested?: Empagliflozin and BI 10773
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Oct 2015
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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Boehringer Ingelheim Investigational Site
San Antonio, Texas

Other trials in United States

About this study

Official title: An Open-label Mechanistic Study to Examine the Effect of Oral Empagliflozin (25 mg q.d.) on Kinetics of Renal Glucose Reabsorption in Patients With Type 2 Diabetes Mellitus and Healthy Controls

Conditions: Diabetes Mellitus, Type 2, Healthy
Being tested: Empagliflozin, BI 10773
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

EmpagliflozinDrug
BI 10773Drug
open label

Study groups in NCT01867307
Study group	Role	What they receive
Healthy Controls	Experimental	healthy controls Receives: Drug: BI 10773
Patients	Experimental	patients with type 2 diabetes mellitus Receives: Drug: Empagliflozin

What is being measured

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

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.
Measured: Baseline and Day 14

Timeline

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

Jun 2013Oct 2015

First posted4 Jun 2013 (estimated)
Study startJun 2013
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01867307
Sponsor's protocol ID: 1245.66
Status last verified: Mar 2017
First submitted: 21 May 2013
Last updated: 11 May 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 28611037
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.
PubMed 28428225

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Mechanistic Study to Examine the Effect of Oral Empagliflozin (25 mg q.d.) on Kinetics of Renal Glucose Reabsorption in Patients With Type 2 Diabetes Mellitus and Healthy Controls
ClinicalTrials.gov ID: NCT01867307
Acronym / sponsor ID: 1245.66
Conditions: Diabetes Mellitus, Type 2, Healthy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jun 2013
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 4 Jun 2013 (estimated)
Results: Posted 11 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Healthy Controls	Experimental	Drug: BI 10773healthy controls
Patients	Experimental	Drug: Empagliflozinpatients with type 2 diabetes mellitus

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Empagliflozin	Drug	Patients
BI 10773open label	Drug	Healthy Controls

Primary outcome

Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)
Time frame: Baseline and 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.

Results and safety

Results posted to the registry on 11 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T2DM Patients	18	15
Healthy Subjects	19	16

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

Time frame: Baseline and Day 14. Mean (Standard Deviation). Unit: (milligram / minute/ 1.73 square meters)

Measure	T2DM Patients n = 15	Healthy Subjects n = 15
Value	-321.7 (214.9)	-256.9 (100.0)

T2DM Patients: Median Difference (Final Values): -220.0 (95% CI -440.6 to -202.7), p <0.0001, Paired t- test
Healthy Subjects: Median Difference (Final Values): -234.0 (95% CI -312.3 to -201.5), p <0.0001, Paired t-test

Population analysed: Analysable set (AS): This data set is based on the PPS and excluded all primary endpoint and exploratory endpoint data for one healthy subject due to outlying values that were identified in the subject's TmG and urine splay data.

Adverse events

Time frame: From first drug administration through the residual effect and/or follow-up period, up to 21 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T2DM Patients	0 of 18 (0%)	14 of 18 (77.8%)	Not reported
Healthy Subjects	0 of 19 (0%)	16 of 19 (84.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28611037Abdul-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.
Derived from this study: PubMed 28428225Al-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Empagliflozin and BI 10773 in people with Diabetes Mellitus, Type 2 and Healthy, run by Boehringer Ingelheim at 1 site in United States.

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 4 inclusion and 4 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 11 May 2017). 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 of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14) (time frame: Baseline and Day 14). 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 NCT01867307, which also lists 2 linked publications.

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 11 May 2017.