Trial Outcomes & Findings for Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days (NCT NCT01969747)

NCT ID: NCT01969747

Last Updated: 2015-04-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

baseline (Day -1) and 7 days after first drug administration (Day 7)

Results posted on

2015-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo tablet; oral administration once daily	Empagliflozin 2.5 mg Empagliflozin 2.5 mg tablet; oral administration once daily	Empagliflozin 10 mg Empagliflozin 10 mg tablet; oral administration once daily	Empagliflozin 25 mg Empagliflozin 25 mg tablet; oral administration once daily
Overall Study STARTED	19	19	19	18
Overall Study COMPLETED	19	19	19	18
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=19 Participants Placebo tablet; oral administration once daily	Empagliflozin 2.5 mg n=19 Participants Empagliflozin 2.5 mg tablet; oral administration once daily	Empagliflozin 10 mg n=19 Participants Empagliflozin 10 mg tablet; oral administration once daily	Empagliflozin 25 mg n=18 Participants Empagliflozin 25 mg tablet; oral administration once daily	Total n=75 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 10.6 • n=5 Participants	41.9 years STANDARD_DEVIATION 12.4 • n=7 Participants	39.6 years STANDARD_DEVIATION 11.6 • n=5 Participants	41.9 years STANDARD_DEVIATION 9.7 • n=4 Participants	41.0 years STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	10 Participants n=4 Participants	53 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline (Day -1) and 7 days after first drug administration (Day 7)

Population: Full analysis set (FAS): all patients randomised, treated with at least one dose of study drug, had a baseline UGE (g/24 h) and a UGE (g/24 h) on Day 1 or Day 7. The last observation carried forward (LOCF) approach was used as the primary method of imputation for missing data.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo tablet; oral administration once daily	Empagliflozin 2.5 mg n=19 Participants Empagliflozin 2.5 mg tablet; oral administration once daily	Empagliflozin 10 mg n=19 Participants Empagliflozin 10 mg tablet; oral administration once daily	Empagliflozin 25 mg n=18 Participants Empagliflozin 25 mg tablet; oral administration once daily
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	-3.56 g/24h Standard Error 4.27	72.45 g/24h Standard Error 7.01	103.33 g/24h Standard Error 6.68	101.79 g/24h Standard Error 6.51

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Empagliflozin 2.5 mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Empagliflozin 10 mg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Empagliflozin 25 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=19 participants at risk Placebo tablet; oral administration once daily	Empagliflozin 2.5 mg n=19 participants at risk Empagliflozin 2.5 mg tablet; oral administration once daily	Empagliflozin 10 mg n=19 participants at risk Empagliflozin 10 mg tablet; oral administration once daily	Empagliflozin 25 mg n=18 participants at risk Empagliflozin 25 mg tablet; oral administration once daily
Metabolism and nutrition disorders Hypoglycaemia	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=19 participants at risk Placebo tablet; oral administration once daily	Empagliflozin 2.5 mg n=19 participants at risk Empagliflozin 2.5 mg tablet; oral administration once daily	Empagliflozin 10 mg n=19 participants at risk Empagliflozin 10 mg tablet; oral administration once daily	Empagliflozin 25 mg n=18 participants at risk Empagliflozin 25 mg tablet; oral administration once daily
Infections and infestations Nasopharyngitis	26.3% 5/19 • From first drug administration until 7 days after last drug administration (Day 35)	10.5% 2/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Infections and infestations Urinary tract infection	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Metabolism and nutrition disorders Hypoglycaemia	89.5% 17/19 • From first drug administration until 7 days after last drug administration (Day 35)	84.2% 16/19 • From first drug administration until 7 days after last drug administration (Day 35)	68.4% 13/19 • From first drug administration until 7 days after last drug administration (Day 35)	94.4% 17/18 • From first drug administration until 7 days after last drug administration (Day 35)
Metabolism and nutrition disorders Polydipsia	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Nervous system disorders Headache	15.8% 3/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	10.5% 2/19 • From first drug administration until 7 days after last drug administration (Day 35)	33.3% 6/18 • From first drug administration until 7 days after last drug administration (Day 35)
Nervous system disorders Dysgeusia	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Nervous system disorders Lumbar radiculopathy	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
Vascular disorders Phlebitis	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Vascular disorders Haematoma	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
Vascular disorders Thrombophlebitis	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
Gastrointestinal disorders Constipation	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Gastrointestinal disorders Diarrhoea	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Gastrointestinal disorders Nausea	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Gastrointestinal disorders Vomiting	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	10.5% 2/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
Musculoskeletal and connective tissue disorders Back pain	10.5% 2/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
Musculoskeletal and connective tissue disorders Neck pain	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)
General disorders Application site erythema	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	5.6% 1/18 • From first drug administration until 7 days after last drug administration (Day 35)
Injury, poisoning and procedural complications Contusion	5.3% 1/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/19 • From first drug administration until 7 days after last drug administration (Day 35)	0.00% 0/18 • From first drug administration until 7 days after last drug administration (Day 35)