Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Phase 3CompletedNCT01719003

Boehringer Ingelheim1,413 enrolled

Overview

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,413

Conditions

Diabetes Mellitus, Type 2 Hyperglycemia

Interventions

Metformin 500 mg bidDRUG

Metformin 500 mg twice daily

Metformin 1000 mg bidDRUG

Metformin 1000 mg twice daily

Empagliflozin low dose qdDRUG

Empagliflozin low dose once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization 3. HbA1c \>=7.5% and \<= 12% (\>=58.5 mmol/mol and \<=107.7 mmol/mol) 4. Body Mass Index (BMI) \<= 45 kg/m2 at screening Exclusion criteria: 1. Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day) 2. Any antidiabetic drug within 12 weeks prior to randomization 3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period 4. Contraindications to metformin according to the local label

Locations (190)

Outcomes

Primary Outcomes

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24

Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means

Time frame: baseline and 24 weeks

Secondary Outcomes

FPG (Fasting Plasma Glucose) Change From Baseline at Week 24

Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.

Time frame: baseline and 24 weeks

Body Weight Change From Baseline at Week 24

Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.

Time frame: baseline and 24 weeks

Data from ClinicalTrials.gov

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1276.1.10014 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1276.1.10019 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1276.1.10044 Boehringer Ingelheim Investigational Site

Manley Hot Springs, Alaska, United States

1276.1.10010 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

1276.1.10035 Boehringer Ingelheim Investigational Site

Searcy, Arkansas, United States

1276.1.10046 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

1276.1.10006 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

1276.1.10043 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

1276.1.10009 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1276.1.10040 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

...and 180 more locations