Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days

Summary

Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DRUG

Empagliflozin medium placebo

Empagliflozin medium placebo

DRUG

Empagliflozin low placebo

Empagliflozin low placebo

DRUG

Empagliflozin low placebo

Empagliflozin low placebo

DRUG

Empagliflozin high placebo

Empagliflozin high placebo

DRUG

Empagliflozin medium

Empagliflozin medium

DRUG

Empagliflozin medium placebo

Empagliflozin medium placebo

DRUG

Empagliflozin high placebo

Empagliflozin high placebo

DRUG

Empagliflozin high placebo

Empagliflozin high placebo

DRUG

Empagliflozin medium placebo

Empagliflozin medium placebo

DRUG

Empagliflozin low placebo

Empagliflozin low placebo

DRUG

Empagliflozin low

Empagliflozin low

DRUG

Empagliflozin high

Empagliflozin high

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2014-04-30

Completion

2014-04-30

Countries

• Austria
• Germany

Study Locations