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Completed

NCT Number: NCT01778049

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1275.10.54005 Boehringer Ingelheim Investigational Site, Caba, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated ICF (Informed Consent Form)
  • Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label
  • HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
  • HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4
  • Age > or equal to 18 years
  • BMI (Body Mass Index) < or equal to 45

Exclusion criteria

  • Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
  • Use of any other antidiabetic
  • Renal function below 60 ml/min/1.73 m2
  • Antiobesity drugs or aggresive diets
  • Gastorintestinal surgeries
  • Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
  • Acute coronary syndrome and stroke within 3 months of informed consent
  • Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors

Treatment and study plan

BI 10773

Drug

Empagliflozin active

BI 10773 Placebo

Drug

Empagliflozin placebo

BI 10773 / BI 1356

Drug

Empagliflozin / Linagliptin 25/5 mg Dose FDC active

BI 10773 / BI 1356 Placebo

Drug

Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC

Primary outcomes

  1. Change From Baseline of HbA1c After 24 Weeks of Treatment.

    Time frame: Baseline and 24 weeks

    Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.

    Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.

Secondary outcomes

  1. Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.

    Time frame: Baseline and 24 weeks

    Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2013
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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