Phase 3
Completed N=606
Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01734785 ↗Enrolled (actual)
606
Serious AEs
3.9%
Results posted
Apr 2016
Primary outcomePrimary: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment — -0.56; -0.65; 0.14 Percentage of HbA1c — p=<0.0001
◆ Published Evidence
Highly cited
131citations · ~15 / year
Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial.
Summary
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.
Linked Publications
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Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment |
-0.56; -0.65; 0.14 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment. |
-1.75; -1.46; 0.34 | <0.0001 sig |
| SECONDARY Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment |
-2.52; -3.06; -0.30 | <0.0001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01734785) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.