Does empagliflozin preserve pancreas function in recently-diagnosed type 1 diabetes?

Phase 2

Completed

• Conditions: type 1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12617000016336
• Lead Sponsor: Melbourne Health

Brief Summary

This study demonstrated that it was feasible and appeared safe to treat adults with recent-onset type 1 diabetes with a tablet called empagliflozin. Treatment was associated with decreased insulin requirements and preservation of beta cell function. However, a larger placebo-controlled study will be needed to show that these effects were due to the tablet rather than the natural history of early type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-05
• Study Completion: 2019-05-20
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Age between 18 and 40 years at time of consent
Type 1 diabetes diagnosed within 100 days of the month 0 visit with antibodies against at least one of the GAD, IA2, ZnT8 or insulin antigens, measured by an accredited clinical laboratory
Demonstrated ability to comply with insulin prescription and to record home glucose readings at least four times a day
A meal-stimulated C-peptide >0.07nmol/l (>0.2ng/ml)

Exclusion Criteria

Contra-indication to empagliflozin
Serious co-morbidity deemed by the study clinician to pose unacceptable risk
Unwilling to accept the rigors of the study, including four meal tolerance tests and frequent sustained periods of home glucose and ketone monitoring
If female: pregnancy, breast feeding or a desire for pregnancy during the study
If female with reproductive potential, refusal to use contraception during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protocol compliance, measured by the frequency of deviation from the study protocol. Deviations will be assessed by pill counts at monthly visits and by reviewing visit data, collected monthly for the first 3 months and then 6-weekly up to 9 months after starting study drug.[9 months after starting study drug.]