Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01289990
First received: January 31, 2011
Last updated: July 14, 2014
Last verified: July 2014

January 31, 2011
July 14, 2014
February 2011
May 2013   (final data collection date for primary outcome measure)
  • Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 52 weeks
  • Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 76 weeks
  • Changes from baseline in clinical laboratory values, changes from baseline of Albumin/creatinine ratio and use of rescue therapy after 52, 76 weeks of treatment and at end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
  • To investigate the long-term safety and tolerability of BI 10773. [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
  • Incidence and intensity of adverse events, hypoglycaemic events, protocol-specified significant adverse events, cardiovascular events (Clinical Event Committee adjudication results) after 52, 76 weeks of treatment and at end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01289990 on ClinicalTrials.gov Archive Site
  • HbA1c (%) Changes From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
  • Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Systolic blood pressure - change from baseline after 52 weeks of treatment
  • Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Systolic blood pressure - change from baseline after 76 weeks of treatment
  • Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Diastolic blood pressure - change from baseline after 52 weeks of treatment
  • Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Diastolic blood pressure - change from baseline after 76 weeks of treatment
  • Body Weight (kg) Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
  • Body Weight (kg) Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
  • Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Waist circumference (cm) - change from baseline after 52 weeks of treatment
  • Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Waist circumference (cm) - change from baseline after 76 weeks of treatment
  • Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Fasting plasma glucose - change from baseline after 52 weeks of treatment
  • Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Fasting plasma glucose - change from baseline after 76 weeks of treatment
  • To assess efficacy of BI 10773 and for patients from 1245.20 sitagliptin for minimum 76 weeks compared to placebo as monotherapy or placebo on a background of pioglitazone or placebo on a background of metformin with or without sulfonylurea. [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
  • The HbA1c, body weight (kg), waist circumference and fasting plasma glucose changes from baseline after 52, 76 weeks of treatment and to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
  • Composite endpoint of the following conditions after 52, 76 weeks of treatment and to end of trial change from baseline in (all three fulfilled): - HbA1c > 0.5% - systolic blood pressure > 3 mmHg - weight >2% [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure: Change from baseline after 52, 76 weeks of treatment and to end of trial For patients rolling over from 1245.20: - Change from baseline in biomarkers of insulin sensitivity and secretion to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: BI 10773
    BI 10773 tablets once daily
  • Drug: Placebo
    Placebo matching BI 10773 low dose
  • Drug: Placebo
    Placebo matching BI 10773 high dose
  • Drug: Placebo
    Placebo matching Sitagliptin
  • Drug: Sitagliptin 100mg
    Sitagliptin once daily
  • Experimental: BI 10773 low (drug naive)
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
    • Drug: Placebo
  • Experimental: BI 10773 high (drug naive)
    BI 10773 tablets once daily
    Interventions:
    • Drug: Placebo
    • Drug: BI 10773
    • Drug: Placebo
  • Placebo Comparator: Placebo (drug naive)
    Placebo tablets matching BI 10773 / Sitagliptin once daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Placebo
  • Active Comparator: Sitagliptin 100mg (drug naive)
    Sitagliptin once daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Sitagliptin 100mg
  • Experimental: BI 10773 low (pioglitazone)
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
  • Experimental: BI 10773 high (pioglitazone)
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
  • Placebo Comparator: Placebo (pioglitazone)
    Placebo tablets matching BI 10773 once daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
  • Experimental: BI 10773 low (metformin)
    BI 10773 tablets once daily
    Interventions:
    • Drug: Placebo
    • Drug: BI 10773
  • Experimental: BI 10773 high (metformin)
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
  • Placebo Comparator: Placebo (metformin)
    Placebo tablets matching BI 10773 once daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
  • Experimental: BI 10773 low (metformin+sulfonylurea)
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
  • Experimental: BI 10773 high (metformin+sulfonylurea)
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
  • Placebo Comparator: Placebo (metformin+sulfonylurea)
    Placebo tablets matching BI 10773
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2705
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
  2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

  1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
  2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
  3. Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
  4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
  5. Pre-menopausal women (last menstruation < or = 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. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
  6. 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.
  7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
  8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   China,   France,   Germany,   Greece,   India,   Ireland,   Japan,   Korea, Republic of,   Mexico,   Philippines,   Slovakia,   Slovenia,   Switzerland,   Taiwan,   Turkey,   Ukraine
 
NCT01289990
1245.31, 2010-022718-17
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP