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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Empagliflozin low placebo; Drug: Empagliflozin high placebo; Drug: Empagliflozin medium placebo; Drug: Empagliflozin low; Drug: Empagliflozin high; Drug: Empagliflozin medium

• Registration Number: NCT01969747
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-25
• Study Start: 2013-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-03-23
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-06
• Last Update Submitted: 2015-04-06
• Results First Posted: 2015-04-08
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin low	Empagliflozin high placebo	Empagliflozin low once daily
Placebo	Empagliflozin medium placebo	Placebo once daily
Empagliflozin low	Empagliflozin low	Empagliflozin low once daily
Empagliflozin medium	Empagliflozin high placebo	Empagliflozin medium once daily
Empagliflozin medium	Empagliflozin low placebo	Empagliflozin medium once daily
Empagliflozin high	Empagliflozin high	Empagliflozin high once daily
Empagliflozin high	Empagliflozin medium placebo	Empagliflozin high once daily
Empagliflozin high	Empagliflozin low placebo	Empagliflozin high once daily
Placebo	Empagliflozin low placebo	Placebo once daily
Empagliflozin low	Empagliflozin medium placebo	Empagliflozin low once daily
Empagliflozin medium	Empagliflozin medium	Empagliflozin medium once daily
Placebo	Empagliflozin high placebo	Placebo once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo	baseline (Day -1) and 7 days after first drug administration (Day 7)	Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo.; The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model.; The primary endpoint is exploratory.

Trial Locations

Locations (2)

1245.78.43001 Boehringer Ingelheim Investigational Site; 🇦🇹 Graz, Austria

1245.78.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany