Empagliflozin Effect on Glucose Toxicity

Sponsor
University Hospital Tuebingen
Study ID
NCT03437330
Phase
PHASE4
Status
Withdrawn

Conditions

  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (Jardiance®) — DRUG
    Empagliflozin Dose/frequency: 10 mg once daily for 12 weeks Route of administration: oral Reference group: Insulin glargine (Lantus®) Dose/frequency: see below FBG 6-7 mmol/L: +2 IU (stop when FBG is reduced by 0.5 mmol/L or documented hypoglycemia \< 3.9 mmol/L occurs) FBG 7-8 mmol/L: +4 IU (stop when FBG is reduced by 1.0 mmol/L or documented hypoglycemia \< 3.9 mmol/L occurs) FBG \> 8 mmol/L: +6 IU (stop when FBG is reduced by 1.5 mmol/L or documented hypoglycemia \< 3.9 mmol/L occurs)
  • Insulin Glargine (Lantus®) — DRUG
    insulin glargine shall be titrated according to the following scheme: If FBG 6-7 mmol/L: reduce fasting glucose by 0.5 mmol/L If FBG 7-8 mmol/L: reduce fasting glucose by 0.75 mmol/L If FBG 8-9 mmol/L: reduce fasting glucose by 1.0 mmol/L Thus, insulin glargine doses should be adapted as follows: FBG 6-7 mmol/L: +2 IU (stop when FBG is reduced by 0.5 mmol/L or documented hypoglycemia \< 3.9 mmol/L occurs) FBG 7-8 mmol/L: +3IU (stop when FBG is reduced by 0.75 mmol/L or documented hypoglycemia \< 3.9 mmol/L occurs) FBG \> 8 mmol/L: +5 IU (stop when FBG is reduced by 1.0mmol/L or documented hypoglycemia \< 3.9 mmol/L occurs)

Study Details

Empagliflozin effect on glucose toxicity in type 2 diabetes patients - a randomized, open-label, controlled, parallel group, exploratory study

Key Dates

First listed
Feb 19, 2018
Start date
Oct 27, 2021
Status verified
May 2024
Primary completion
May 3, 2023
Completion
May 3, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin (Jardiance®)
    Dose/frequency: 10 mg once daily for 12 weeks Route of administration: oral
  • Active Comparator: Insulin Glargine (Lantus®)
    Thus, insulin glargine doses should be adapted as follows: FBG 6-7 mmol/L: +2 IU FBG 7-8 mmol/L: +3 IU FBG \> 8 mmol/L: +5 IU

Primary Outcome Measure

Change in skeletal muscle H202 concentration between baseline and end of treatment (EoT) [ Time Frame: 12 weeks ]

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