Clinical trial NCT02540486: Long Acting Insulin Glargine Titration Web Tool (LTHome) vs Enhanced Usual Therapy of Glargine Titration
Official title: A 12 Week, Parallel, Open-label, Randomized, Multi-center Study Evaluating Use, Safety and Effectiveness of a Web Based Tool vs. Enhanced Usual Therapy of Glargine Titration in T2DM Patients With a 4 Week Safety Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes
T2DM
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2015-09-04
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating patients with type 2 diabetes either starting once daily basal insulin or requiring increased basal titrations in order to compare the LTHome web based tool with the usual standard of practice for insulin glargine dosing adjustment.

Detailed description: INNOVATE is a 12 week, parallel, open-label, randomized, multi-center study evaluating use, safety and effectiveness of a web based tool (LTHome) vs. enhanced usual therapy (EUT) of glargine titration in T2DM patients.

The primary objective of this study is to compare the effectiveness LTHome versus EUT of glargine titration in people with T2DM patients on basal insulin not meeting local targets or patients requiring basal initiation. Success will be measured by the percentage of subjects reaching Canadian Diabetes Association (CDA) guideline targets.

The efficacy objective is to demonstrate that the percentage (%) of subjects to reach FPG target by titration of insulin glargine using the LTHome tool with dose adjustment advice is not inferior to the % of subjects to reach FPG target using Enhanced Usual Therapy glargine titration during study participation (LTHome vs. EUT treatments).

The secondary objectives of this study are to assess safety, effectiveness, satisfaction and adherence of LTHome use versus Enhanced Usual Therapy glargine titration.

Eligibility criteria: Inclusion Criteria:

* Patient with type 2 diabetes mellitus (T2DM) between 18 and 75 years old (inclusively) with BMI ≤ 45 kg/m2.
* Signed written informed consent
* Patients scheduled to: initiate basal insulin treatment or increase their dose of current basal insulin therapy, independently of study participation, because of :

  • inadequate blood glucose control
* If on basal therapy at screening, must be using a stable dose of insulin glargine x 1 week prior to randomization
* Patients with poor blood glucose control defined by:

  * HbA1c level between \> 7% at screening AND
  * mean FPG \> 7 mmol/l as determined by most recent self-measured blood glucose in 3 of 7 days prior to randomization
* Patients proficient in computer literacy
* Patient is able and willing to monitor glucose with a home glucose monitor, and consistently record his/her blood glucose and insulin doses in a patient diary/web tool.

Exclusion Criteria:

* Any technical/administrative reason that makes it impossible to include the patient in the study, including closing enrollment due to full enrollment
* Patient who has previously participated in any clinical trial investigating the LTHome algorithm
* Patient who withdraws consent during screening (starting from signed informed consent form)
* Use of systemic steroids in the last 90 days
* Conditions/situations:

  * Patients with short life expectancy (less than 1 year)
  * Type 1 diabetes mellitus
  * Patients with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint
  * Clinically significant cardiac disease, retinopathy, hepatic, renal dysfunction or relevant other major diseases as determined by Principal Investigator or designee.
  * Unstable oral antihyperglycemic drugs and/or Glucagon-Like Peptide Receptor (GLP-1R) Agonists therapy during the 4 week period prior to screening
  * Impossibility to meet specific protocol requirements (e.g. ability to perform blood glucose measurements, manage their own insulin glargine administration or deemed unlikely to safely manage insulin dosage on guidance by their HCP)
  * Patient is a primary relative of the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, or other staff or is directly involved in the conduct of the protocol
  * Patients with hypoglycemia unawareness, severe hypoglycemic episode in the last 90 days or hospitalization (for any reason) in the last 30 days
  * Cognitive disorder, dementia or any neurologic disorder, that would affect patient's ability to participate in the study, or patients who have no legal capacity or are under guardianship
* Pregnant or breastfeeding women, or women of child-bearing potential not protected by highly effective method(s) of birth control (as defined in the informed consent form and/or in a local protocol addendum) and who are unwilling or unable to be tested for pregnancy.
* Patients who are using, or need to start using, mealtime (Bolus) insulin during the timeframe of the study.
* Night shift workers

Primary outcomes:
measure: Percentage of subjects reaching fasting plasma glucose (FPG) target
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of days to first reach fasting plasma glucose target
timeFrame: 12 weeks
measure: Number of days in target range after reaching fasting plasma glucose target
timeFrame: 12 weeks
measure: Fasting plasma glucose
timeFrame: 12 weeks
measure: Hemoglobin A1c (HbA1c)
timeFrame: 12 weeks
measure: Rate of documented hypoglycemia in subjects that reach target
timeFrame: 12 weeks
measure: Rate of documented hypoglycemia in subjects that do not reach target
timeFrame: 12 weeks
measure: Proportion of all patients with hypoglycemia
timeFrame: 12 weeks
measure: Frequency of contact with physician/HCP
timeFrame: 12 weeks
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: 12 weeks
measure: Hypoglycemia Fear Survey (HFS)
timeFrame: 12 weeks
measure: WHO-5 Well-Being Index
timeFrame: 12 weeks
measure: Diabetes Distress Scale
timeFrame: 12 weeks
measure: LTHome Patient Satisfaction Survey
timeFrame: 12 weeks
measure: Number of days subjects self-monitored their fasting plasma glucose
timeFrame: 12 weeks
measure: Number of dose recommendations prior to reaching target - LTHome only
timeFrame: 12 weeks
measure: Number of dose recommendations after target is reached - LTHome only
timeFrame: 12 weeks
measure: Number of days insulin glargine was taken - LTHome only
timeFrame: 12 weeks
measure: Reasons for disregarding LTHome advice - LTHome only
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Serious adverse events
timeFrame: 12 weeks
Other outcomes:
measure: Body weight (kg)
timeFrame: 12 weeks
measure: List of concomitant medications initiated after randomization
timeFrame: 12 weeks
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes & Endocrinology
state: Ontario
Study officials:
affiliation: LMC Diabetes & Endocrinology Ltd.
name: Ronnie Aronson, MD
role: PRINCIPAL_INVESTIGATOR
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