Back to Search
Start Over
Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study
- Source :
- The Lancet. 382:409-416
- Publication Year :
- 2013
- Publisher :
- Elsevier BV, 2013.
-
Abstract
- Guidelines suggest setting individualised targets for glycaemic control in elderly patients with type 2 diabetes, despite no evidence. We aimed to assess the feasibility of setting and achieving individualised targets over 24 weeks along with conventional HbA1c reduction using vildagliptin versus placebo.In this multinational, double-blind, 24 week study, we enrolled drug-naive or inadequately controlled (glycosylated haemoglobin A1c [HbA1c] ≥7·0% to ≤10·0%) patients with type 2 diabetes aged 70 years or older from 45 outpatient centres in Europe. Investigators set individualised treatment targets on the basis of age, baseline HbA1c, comorbidities, and frailty status before a validated automated system randomly assigned patients (1:1) to vildagliptin (50 mg once or twice daily as per label) or placebo. Coprimary efficacy endpoints were proportion of patients reaching their investigator-defined HbA1c target and HbA1c reduction from baseline to study end. The study is registered with ClinicalTrials.gov, number NCT01257451, and European Union Drug Regulating Authorities Clinical Trials database, number 2010-022658-18.Between Dec 22, 2010, and March 14, 2012, we randomly assigned 139 patients each to the vildagliptin and placebo groups. 37 (27%) of 137 patients in the placebo group achieved their individualised targets by education and interactions with the study team alone and 72 (52·6%) of 137 patients achieved their target in the vildagliptin group (adjusted odds ratio 3·16, 96·2% CI 1·81-5·52; p0·0001). This finding was accompanied by a clinically relevant 0·9% reduction in HbA1c from a baseline of 7·9% with vildagliptin and a between-group difference of -0·6% (98·8% CI -0·81 to -0·33; p0·0001). The overall safety and tolerability was similar in the vildagliptin and placebo groups, with low incidence of hypoglycaemia and no emergence of new safety signals.This study is the first to introduce and show the feasibility of using individualised HbA1c targets as an endpoint in any type 2 diabetes population. Individualised glycaemic target levels are achievable with vildagliptin without any tolerability issues in the elderly type 2 diabetes population.Novartis Pharma AG.
- Subjects :
- Male
medicine.medical_specialty
Pyrrolidines
Population
Placebo-controlled study
Adamantane
Type 2 diabetes
Placebo
law.invention
Double-Blind Method
Randomized controlled trial
law
Internal medicine
Nitriles
medicine
Humans
Hypoglycemic Agents
media_common.cataloged_instance
Vildagliptin
Precision Medicine
European union
education
Aged
media_common
Aged, 80 and over
Glycated Hemoglobin
education.field_of_study
business.industry
General Medicine
medicine.disease
Hypoglycemia
Metformin
Surgery
Sulfonylurea Compounds
Treatment Outcome
Diabetes Mellitus, Type 2
Tolerability
Feasibility Studies
Drug Therapy, Combination
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 01406736
- Volume :
- 382
- Database :
- OpenAIRE
- Journal :
- The Lancet
- Accession number :
- edsair.doi.dedup.....7e61a6f83a827a6201097e1a3b992e9a