Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01210001
• Date of registration: 27/09/2010
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
• Scientific title: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin
• Date of first enrolment: September 2010
• Target sample size: 499
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01210001
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, China, Greece, India, Philippines, Thailand, Ukraine, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent.

2. Male and female patients on diet and exercise regimen who are pre-treated with
pioglitazone alone or in combination with metformin. The treatment regimen should be
unchanged for 12 weeks prior to randomisation.

3. HbA1c of >/= 7.0% and
4. Age >/= 18.

5. BMI
6. Signed and dated written informed consent by date of Visit 1 in accordance with Good
Clinical Practice (GCP) and local legislation.

Exclusion criteria:

1. 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).

2. Any other antidiabetic medication within 12 weeks prior to randomisation, except those
defined as the permitted background therapy via inclusion criteria no. 2.

3. Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months
prior to informed consent.

4. Indication of liver disease, defined by serum levels of either alanine transaminase
(ALT/SGPT), aspartate transaminase (AST/SGOT), or alkaline phosphatase above 3 x upper
limit of normal (ULN) as determined during screening or during the placebo run-in
period (i.e. at a visit prior to the randomisation visit, Visit 3).

5. Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30
ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula)
as determined during screening or during the placebo run-in period (i.e. at a visit
prior to the randomisation visit, Visit 3).

6. Bariatric surgery within the past two years and other gastrointestinal surgeries that
induce chronic malabsorption.

7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for
cancer within the last 5 years .

8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g.
malaria, babesiosis, haemolytic anaemia).

9. Contraindications to pioglitazone according to the local label.

10. Contraindication to pioglitazone and/or metformin (relevant only for those patients
who enter the study with both these background therapies) according to the local
labels.

11. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 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.

12. 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 T2D.

13. Pre-menopausal women (last menstruation
- 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 trial
and do not agree to submit to periodic pregnancy testing during participation in
the trial. Acceptable methods of birth control include tubal ligation,
transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable
or injectable contraceptives, sexual abstinence (if acceptable to local
authorities), double barrier method and vasectomised partner.

14. Alcohol or drug abuse 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.

15. Participation in another trial with an investigational drug within 30 days prior to
informed consent.

16. Any other clinical condition that would jeopardise patient safety while participating
in this clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Placebo

Drug: BI 10773

Primary Outcome(s)

HbA1c Change From Baseline [Time Frame: Baseline and 24 weeks]

HbA1c Change From Baseline for Pio and Met Background Medication Patients [Time Frame: Baseline and 24 weeks]

Secondary Outcome(s)

Body Weight Change From Baseline [Time Frame: Baseline and 24 weeks]

Fasting Plasma Glucose (FPG) Change From Baseline [Time Frame: Baseline and 24 weeks]

Secondary ID(s)

2009-016154-40

1245.19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company

Results

• Results available: Yes
• Date Posted: 17/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01210001