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NCT02702011

Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus

Completed Phase 2 Results posted Last updated 2 April 2018
What this trial tests

Phase 2 trial testing empagliflozin medium dose in Diabetes Mellitus, Type 1 in 48 participants. Completed in 3 October 2016.

Timeline
20 March 2016
Primary endpoint
5 September 2016
3 October 2016

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment48
Start date20 March 2016
Primary completion5 September 2016
Estimated completion3 October 2016
Sites4 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 20 to 65, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in 24 Hour UGE on Day 7 Primary · Baseline and 7 days

Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.

GroupValue95% CI
Placebo-0.46± 7.96
Empagliflozin 2.5 mg64.63± 7.31
Empagliflozin 10 mg80.73± 7.68
Empagliflozin 25 mg97.64± 7.63

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration till 7 days after last drug intake; up to 35 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 0/11 (0%)
Deaths:
Empagliflozin 2.5 mg
Serious: 0/13 (0%)
Deaths:
Empagliflozin 10 mg
Serious: 0/12 (0%)
Deaths:
Empagliflozin 25 mg
Serious: 0/12 (0%)
Deaths:
Other adverse events (14 terms — click to expand)

ReactionSystemPlaceboEmpagliflozin 2.5 mgEmpagliflozin 10 mgEmpagliflozin 25 mg
HypoglycaemiaMetabolism and nutrition disorders
Vulvovaginal candidiasisInfections and infestations
Decreased appetiteMetabolism and nutrition disorders
HeadacheNervous system disorders
Retinal haemorrhageEye disorders
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders
Connective tissue inflammationMusculoskeletal and connective tissue disorders
ContusionInjury, poisoning and procedural complications
Dizziness posturalNervous system disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
Faeces softGastrointestinal disorders
Alanine aminotransferase increasedInvestigations

Data from ClinicalTrials.gov NCT02702011 adverse events section.

Sponsor's own description

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Empagliflozin as adjunct to insulin in Japanese participants with type 1 diabetes: Results of a 4-week, double-blind, randomized, placebo-controlled phase 2 trial.
    Shimada A, Hanafusa T, Yasui A, Lee G, et al · · 2018 · cited 33× · PMID 29766633 · DOI 10.1111/dom.13351
  2. Risk of diabetic ketoacidosis caused by sodium glucose cotransporter-2 inhibitors in patients with type 1 diabetes: a systematic review and network meta-analysis of randomized controlled trials.
    Liu Y, Yang S, Jiang A, Zou D, et al · · 2024 · cited 2× · PMID 39957850 · DOI 10.3389/fendo.2024.1453067
  3. Treatment-duration-wise harm profile of insulin-sodium-glucose co-transporter inhibitor co-treatment in type 1 diabetes mellitus patients.
    Saha S, Saha S, Gayen M. · · 2023 · cited 2× · PMID 37255836 · DOI 10.1007/s40200-023-01192-7

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02702011.

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