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.
BakerIDI Heart and Diabetes Institute
72 participants
Dec 9, 2013
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- Type 1 diabetes duration> 2 years
- HbA1c 7.0% to 10.0%
- MDI or CSII therapy
Exclusion Criteria4
- Premix insulin regime
- Type 2 diabetes
- Severe hypoglycaemia in past 3 months
- Pregnant, lactating or planning pregnancy
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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
Locations(1)
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ACTRN12613001056785