Diabetes Mellitus, Type 2Phase 2NCT01248364

A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects

A Phase 2 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

An open-label, phase II study to assess the acute and chronic effects of empagliflozin (BI 10773)on fasting and postprandial glucose homeostasis in patients with IGT and type 2 diabetes mellitus and assess the acute effects of empagliflozin in healthy subjects. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 3 sitesin 3 countries
Study dates: Nov 2010to Jul 2013
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female patients diagnosed with IGT according to the current ADA guidelines as a two-hour glucose levels of 140 to 199 mg/dl (7.8 mmol/l to 11.1 mmol/l) on the 75-g oral glucose tolerance test (OGTT), with an OGTT performed at the time of the screening visit (Visit 1), or
¿ Male and female patients diagnosed with type 2 diabetes mellitus (T2DM) prior to informed consent, on diet and exercise regimen who are drug-naïve, defined as absence of any oral antihyperglycemic therapy for 12 weeks prior starting with open-label active treatment, or
Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, who are pre-treated with metformin background therapy, on a stable dose of metformin of at least 1500 mg per day, unchanged for at least 12 weeks prior starting with open-label active treatment
HbA1c at Visit 1 (screening)
for patients diagnosed of IGT and for healthy subjects: HbA1c < 6.5%
for patients diagnosed of T2DM: HbA1c =6.5% and =10.5%

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Age = 18 at Visit 1
BMI = 20 and = 40 Kg/m2 at Visit 1
For patients with antihypertensive treatment, this must be stable (with no change in dosage) within 4 weeks prior starting with open-label active treatment
Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
Males or females matching the below mentioned criteria and otherwise healthy according to the investigator¿s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR) and clinical laboratory tests .
HbA1c at Visit 1 (screening): HbA1c < 6.5%
Confirmed normal glucose tolerance (NGT) by OGTT
Age = 45 and = 55 at Visit 1.
BMI = 30 and = 40 Kg/m2 (Body Mass Index) at Visit 1.
Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Who cannot join

Acute coronary syndrome (non-STEMI [ST elevation myocardial infarction], STEMI, unstable AP [angina pectoris]), stroke or Transient Ischemic Attack (TIA) within 6 months prior to informed consent.
Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
Any other antidiabetic drug within 12 weeks prior to starting the open-label active treatment (Visit 4) except those defined as background via inclusion criterion 1c.
Indication of liver disease, defined by serum levels of either Alanine Aminotransferase (ALT [SGPT]), Aspartate Aminotransferase (AST [SGOT]), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase.
Impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) < 60 ml/min (moderate and severe renal impairment) as determined during screening and/or run-in phase.
Medical history of insufficient bladder emptying (i.e. neurogenic bladder disorders).

Show all 17Show fewer

Patients with an Haemoglobin (Hb) < 11.5 g/dl (for males) and Hb < 10.5 g/dl (for females) at Visit 1.
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption within the last 5 years.
Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
For patients on metformin background therapy, the investigator must check for potential exclusion criteria according to local metformin label.
Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM. However, the use of inhaled steroids (e.g., for asthma, Chronic Obstructive Pulmonary Disease [COPD]) is not an exclusion as these do not cause systemic steroid action.
Alcohol or drug abuse (according to investigators judgment) within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
Intake of an investigational drug in another trial Participation in another trial within 30 days prior to intake of study medication in this trial.
Pre-menopausal women (last menstruation < = 1 year prior to informed consent) who:
Are nursing or pregnant or Are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Austria1 site

1245.39.43001 Boehringer Ingelheim Investigational Site
Graz

Other trials in Austria

Germany1 site

1245.39.49002 Boehringer Ingelheim Investigational Site
Neuss

Other trials in Germany

Italy1 site

1245.39.39001 Boehringer Ingelheim Investigational Site
Pisa

Other trials in Italy

About this study

Official title: An Open-label, Phase II Study to Determine Acute (After the First Dose Administration) and Chronic (After 28 Days of Treatment) Effects of the Sodium-glucose Co-transporter-2 (SGLT-2) Inhibitor Empagliflozin (BI 10773) (25 mg Once Daily) on Pre and Postprandial Glucose Homeostasis in Patients With IGT and, Type 2 Diabetes Mellitus and Healthy Subjects

Conditions: Diabetes Mellitus, Type 2
Being tested: 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.

BI 10773Drug
BI 10773 tablets once daily high dose

Study groups in NCT01248364
Study group	Role	What they receive
BI 10773 Arm	Experimental	BI 10773 high dose once daily Receives: Drug: BI 10773

What is being measured

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

Change From Baseline in Fasting Plasma Glucose at Day 1
Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1
Measured: Baseline and day 1
Change From Baseline in Fasting Plasma Glucose at Day 28
Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable
Measured: Baseline and day 28
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1
Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.
Measured: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28
Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Measured: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28

Secondary outcomes (6)

Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1
Change from baseline in rate of endogenous glucose production (EGP) fast after one dose
Measured: Baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28
Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Measured: Baseline and day 28
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1
Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.
Measured: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28
Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Measured: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1
Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.
Measured: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28
Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Measured: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28

Timeline

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

Nov 2010Jul 2013

First posted25 Nov 2010 (estimated)
Study startNov 2010
Primary completionJul 2013
Study completionJul 2013

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 (3)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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01248364
Sponsor's protocol ID: 1245.39
Other IDs: 2010-018708-99
Status last verified: Aug 2014
First submitted: 24 Nov 2010
Last updated: 9 Sep 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Ferrannini E, Baldi S, Frascerra S, Astiarraga B, Barsotti E, Clerico A, Muscelli E. Renal Handling of Ketones in Response to Sodium-Glucose Cotransporter 2 Inhibition in Patients With Type 2 Diabetes. Diabetes Care. 2017 Jun;40(6):771-776. doi: 10.2337/dc16-2724. Epub 2017 Mar 21.
PubMed 28325783
Muscelli E, Astiarraga B, Barsotti E, Mari A, Schliess F, Nosek L, Heise T, Broedl UC, Woerle HJ, Ferrannini E. Metabolic consequences of acute and chronic empagliflozin administration in treatment-naive and metformin pretreated patients with type 2 diabetes. Diabetologia. 2016 Apr;59(4):700-8. doi: 10.1007/s00125-015-3845-8. Epub 2015 Dec 24.
PubMed 26704626
Ferrannini E, Muscelli E, Frascerra S, Baldi S, Mari A, Heise T, Broedl UC, Woerle HJ. Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients. J Clin Invest. 2014 Feb;124(2):499-508. doi: 10.1172/JCI72227. Epub 2014 Jan 27.
PubMed 24463454

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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Phase II Study to Determine Acute (After the First Dose Administration) and Chronic (After 28 Days of Treatment) Effects of the Sodium-glucose Co-transporter-2 (SGLT-2) Inhibitor Empagliflozin (BI 10773) (25 mg Once Daily) on Pre and Postprandial Glucose Homeostasis in Patients With IGT and, Type 2 Diabetes Mellitus and Healthy Subjects
ClinicalTrials.gov ID: NCT01248364
Acronym / sponsor ID: 1245.39
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 25 Nov 2010 (estimated)
Results: Posted 9 Sep 2014

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 10773 Arm	Experimental	Drug: BI 10773BI 10773 high dose once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male and female patients diagnosed with IGT according to the current ADA guidelines as a two-hour glucose levels of 140 to 199 mg/dl (7.8 mmol/l to 11.1 mmol/l) on the 75-g oral glucose tolerance test (OGTT), with an OGTT performed at the time of the screening visit (Visit 1), or
¿ Male and female patients diagnosed with type 2 diabetes mellitus (T2DM) prior to informed consent, on diet and exercise regimen who are drug-naïve, defined as absence of any oral antihyperglycemic therapy for 12 weeks prior starting with open-label active treatment, or
Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, who are pre-treated with metformin background therapy, on a stable dose of metformin of at least 1500 mg per day, unchanged for at least 12 weeks prior starting with open-label active treatment
HbA1c at Visit 1 (screening)
Age = 18 at Visit 1

Key exclusion criteria (17 listed)

Acute coronary syndrome (non-STEMI [ST elevation myocardial infarction], STEMI, unstable AP [angina pectoris]), stroke or Transient Ischemic Attack (TIA) within 6 months prior to informed consent.
Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
Any other antidiabetic drug within 12 weeks prior to starting the open-label active treatment (Visit 4) except those defined as background via inclusion criterion 1c.
Indication of liver disease, defined by serum levels of either Alanine Aminotransferase (ALT [SGPT]), Aspartate Aminotransferase (AST [SGOT]), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase.
Impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) < 60 ml/min (moderate and severe renal impairment) as determined during screening and/or run-in phase.

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
BI 10773BI 10773 tablets once daily high dose	Drug	BI 10773 Arm

Primary outcome

Change From Baseline in Fasting Plasma Glucose at Day 1
Time frame: Baseline and day 1
Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1
Change From Baseline in Fasting Plasma Glucose at Day 28
Time frame: Baseline and day 28
Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1
Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28
Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.

6 secondary outcomes

Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1
Time frame: Baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28
Time frame: Baseline and day 28
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28

Results and safety

Results posted to the registry on 9 Sep 2014, 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 Naive	32	32
T2DM Metformin	34	33
Impaired Glucose Tolerance	13	13
Healthy Subjects	12	12

Primary outcome: Change From Baseline in Fasting Plasma Glucose at Day 1

Time frame: Baseline and day 1. Least squares mean (Standard Error). Unit: mmol/L

Measure	T2DM Naive n = 32	T2DM Metformin n = 34	Impaired Glucose Tolerance n = 13	Healthy Subjects n = 12
Value	0.20 (0.12)	0.39 (0.13)	-0.96 (0.86)	-0.47 (0.97)

T2DM Naive vs T2DM Metformin: Mean Difference (Final Values): 0.19 (95% CI -0.16 to 0.55), p = 0.2790, ANCOVA

Population analysed: Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR))

Primary outcome: Change From Baseline in Fasting Plasma Glucose at Day 28

Time frame: Baseline and day 28. Least squares mean (Standard Error). Unit: mmol/L

Measure	T2DM Naive n = 32	T2DM Metformin n = 33	Impaired Glucose Tolerance n = 13	Healthy Subjects n = 0
Value	-1.02 (0.13)	-0.79 (0.15)	-0.81 (1.12)	–

T2DM Naive vs T2DM Metformin: Mean Difference (Final Values): 0.23 (95% CI -0.16 to 0.62), p = 0.2438, ANCOVA

Population analysed: Treated set, which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)), for patients who completed the day 28 visit

Primary outcome: Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1

Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1. Least squares mean (Standard Error). Unit: g/dL/h

Measure	T2DM Naive n = 32	T2DM Metformin n = 34	Impaired Glucose Tolerance n = 13	Healthy Subjects n = 11
Value	-1.94 (0.53)	-3.52 (0.61)	-5.49 (1.95)	-9.20 (3.91)

T2DM Naive vs T2DM Metformin: Mean Difference (Final Values): -1.58 (95% CI -3.20 to 0.04), p = 0.0552, ANCOVA

Population analysed: Treated set (OR)

Primary outcome: Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28

Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28. Least squares mean (Standard Error). Unit: g/dL/h

Measure	T2DM Naive n = 32	T2DM Metformin n = 33	Impaired Glucose Tolerance n = 13	Healthy Subjects n = 0
Value	-0.71 (0.67)	-0.40 (0.72)	-7.31 (2.91)	–

T2DM Naive vs T2DM Metformin: Mean Difference (Final Values): 0.31 (95% CI -1.66 to 2.27), p = 0.7561, ANCOVA

Population analysed: Treated set (OR) for patients who completed the day 28 visit

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first intake of study drug until 7 days after the last treatment intake, 5 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T2DM Naive	0 of 32 (0%)	8 of 32 (25%)	Not reported
T2DM Metformin	1 of 34 (2.9%)	5 of 34 (14.7%)	Not reported
Impaired Glucose Tolerance	0 of 13 (0%)	4 of 13 (30.8%)	Not reported
Healthy Subjects	0 of 12 (0%)	1 of 12 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28325783Ferrannini E, Baldi S, Frascerra S, Astiarraga B, Barsotti E, Clerico A, Muscelli E. Renal Handling of Ketones in Response to Sodium-Glucose Cotransporter 2 Inhibition in Patients With Type 2 Diabetes. Diabetes Care. 2017 Jun;40(6):771-776. doi: 10.2337/dc16-2724. Epub 2017 Mar 21.
Derived from this study: PubMed 26704626Muscelli E, Astiarraga B, Barsotti E, Mari A, Schliess F, Nosek L, Heise T, Broedl UC, Woerle HJ, Ferrannini E. Metabolic consequences of acute and chronic empagliflozin administration in treatment-naive and metformin pretreated patients with type 2 diabetes. Diabetologia. 2016 Apr;59(4):700-8. doi: 10.1007/s00125-015-3845-8. Epub 2015 Dec 24.
Derived from this study: PubMed 24463454Ferrannini E, Muscelli E, Frascerra S, Baldi S, Mari A, Heise T, Broedl UC, Woerle HJ. Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients. J Clin Invest. 2014 Feb;124(2):499-508. doi: 10.1172/JCI72227. Epub 2014 Jan 27.
Related InfoLink provided by the sponsor.

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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

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites in 3 countries.

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 16 inclusion and 17 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 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria, Germany, Italy. 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 9 Sep 2014). 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 in Fasting Plasma Glucose at Day 1 (time frame: Baseline and day 1). The study lists 4 primary outcomes in all. 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 NCT01248364, which also lists 3 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 9 Sep 2014.