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Completed

NCT Number: NCT01734785

Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

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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

1275.9.61009 Boehringer Ingelheim Investigational Site, Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of type 2 diabetes mellitus.
  • Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
  • HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
  • Age 18 years or more at screening.
  • Body Mass Index lower or equal to 45 kg/m2 at screening visit.
  • Signed and dated written informed consent.

Exclusion criteria

  • Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
  • Use of any other antidiabetic drug (except metformin background therapy).
  • Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
  • Indication of liver disease.
  • Impaired renal function.
  • Gastrointestinal surgery.
  • Treatment with anti-obesity drugs within 3 months prior to screening, 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 uncontrolled endocrine disorder except type 2 diabetes mellitus.

Treatment and study plan

Linagliptin

Drug

tablet

EMPAGLIFLOZIN + LINAGLIPTIN

Drug

Fixed dose combination.

Empagliflozin placebo + Linagliptin placebo

Drug

Matching Empagliflozin + Linagliptin low dose

Primary outcomes

  1. HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment

    Time frame: Baseline and 24 weeks

    Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.

Secondary outcomes

  1. Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.

    Time frame: Baseline and 24 weeks

    Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.

  2. Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment

    Time frame: Baseline and 24 weeks

    Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 28, 2012
Registry last updated
Sep 19, 2024

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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