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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Empagliflozin + Linagliptin; Drug: Linagliptin; Drug: Empagliflozin placebo + Linagliptin placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01734785

2012-002270-31 (EudraCT Number)

1275.9

Details and patient eligibility

About

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.

Enrollment: 607 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of type 2 diabetes mellitus.
2. 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.
3. HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
4. Age 18 years or more at screening.
5. Body Mass Index lower or equal to 45 kg/m2 at screening visit.
6. Signed and dated written informed consent.

Exclusion criteria

1. Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
2. Use of any other antidiabetic drug (except metformin background therapy).
3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
4. Indication of liver disease.
5. Impaired renal function.
6. Gastrointestinal surgery.
7. 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.
8. Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

607 participants in 3 patient groups

Linagliptin

Active Comparator group

Description:

5 mg once daily

Treatment:

Drug: Empagliflozin placebo + Linagliptin placebo

Drug: Linagliptin

Empagliflozin + Linagliptin low dose

Experimental group

Description:

1 tablet once daily

Treatment:

Drug: Empagliflozin + Linagliptin

Drug: Empagliflozin + Linagliptin

Drug: Empagliflozin + Linagliptin

Drug: Empagliflozin + Linagliptin

Empagliflozin + Linagliptin high dose

Experimental group

Description:

1 tablet once daily

Treatment:

Drug: Empagliflozin + Linagliptin

Drug: Empagliflozin + Linagliptin

Drug: Empagliflozin + Linagliptin

Drug: Empagliflozin + Linagliptin