Vildagliptin in type 1 diabetes mellitus added to insulin

A randomised, double-blind, parallel arm, placebo controlled trial to determine the effect of vildagliptin used in combination with insulin therapy on glycaemic variability in adults with type 1 diabetes mellitus of at least 2 years duration.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001056785

Acronym

VITAL

Enrollment

Registered

2013-09-23

Start date

2013-12-09

Completion date

2016-12-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Type 1 diabetes is associated with significant fluctuations in blood glucose levels in patients on multiple daily insulin injections or insulin pump therapy. This glycaemic variability limits patients ability to adequately control blood glucose due to its association with hypoglycaemia and subsequent high readings or 'rebounds'. The medication vildagliptin is currently used in the treatment of type 2 diabetes and in this setting has the ability to lower glucose and reduce hypoglycaemia. Its action is both on insulin producing cells, beta cells, and glucagon producing cells, alpha cells. Patients with type 1 diabetes have traditionally been thought to have no insulin production, however recent studies using a more sensitive assay have shown residual beta cell function in many type 1 patients after 10 years. This study is designed to assess the effects of vildagliptin in patients with type 1 diabetes and aspects of blood glucose control including glycaemic variablity. The hypothesis is that vildagliptin may reduce variability due to its action on both alpha and beta cell activity in a glucose dependent manner.

Interventions

Vildagliptin 50 mg twice daily ,orally will be added to usual insulin therapy for a period of 3 months with the comparator group receiving placebo. Adherence will be monitored by tablet return

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Type 1 diabetes duration> 2 years HbA1c 7.0% to 10.0% MDI or CSII therapy

Exclusion criteria

Premix insulin regime Type 2 diabetes Severe hypoglycaemia in past 3 months Pregnant, lactating or planning pregnancy

Outcome results