Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
Primary Objective: The primary objective of this study is to obtain efficacy and safety descriptive data on 2 different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients. Secondary Objective: The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin [A1C], fasting plasma glucose [FPG], 7-point self-measure plasma glucose [SMPG], insulin dose and weight) and determine patient related outcome and health care professional satisfaction as it pertains to each titration regimen.

Detailed Description
-----------------
The total study duration is approximately 14 weeks (2 weeks screening and 12 weeks treatment) with a 2-day safety follow-up and a study extension of 12 weeks for eligible patients.

Official Title
-----------------
A Pilot Descriptive Canadian, Multicenter, Open-label, Randomized Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: INSULIN GLARGINE (U300)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with type 2 diabetes mellitus. Patients who are ≥18 years of age. Treated for diabetes for at least 6 months. If on basal insulin, stable for at least 3 months prior to screening visit on their basal insulin treatment(s) (±20% total insulin dose) If on NIAHA, stable for at least 8 weeks prior to screening visit on their NIAHA(s) (no change in dose or initiation of new NIAHAs). Patients on uncontrolled basal insulin (insulin glargine, normal protamine Hagedorn [NPH], detemir) +/ NIAHAs with an A1c >7.0% and ≤10% or uncontrolled on NIAHAs (insulin naïve patients) with an A1c >7.0% and ≤11%. Signed informed consent form. Exclusion criteria: Patients with type 1 diabetes mellitus (T1DM). Nightshift worker. Female patients who are pregnant or lactating. Treatment with an insulin other than basal insulin (premixes, rapid insulin, fast acting insulin analogues) within the previous 3 months. Patients with less than 1 year history of diabetes. Patients unwilling to inject insulin or perform self-monitoring blood glucose. Current alcohol or drug abuse. Patients unlikely to comply with the protocol and complete the study eg, uncooperative attitude, inability to return for follow-up visits. Patients with active cancer or any other diseases or conditions which in the opinion of the Investigator would make the patient unsuitable for participation in the study. Any clinically significant laboratory findings that in the judgment of the Investigator would preclude safe completion of the study. Known allergies to study drugs. Participation in another clinical study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 (INSIGHT titration algorithm)<br>INSULIN GLARGINE (U300): self-titration of insulin glargine 300 units/mL (U300) will be increased daily by 1 unit until fasting SMPG reaches the target range of 4.4 to 5.6 mmol/L | Drug: INSULIN GLARGINE (U300)<br>* Pharmaceutical form: pre-filled disposable pen Route of administration: subcutaneous<br>* Other names: HOE901;|
| Experimental: Cohort 2 (EDITION titration algorithm)<br>INSULIN GLARGINE (U300): titration of insulin glargine 300 units/mL (U300) will be adjusted weekly or not more than every 3 days to achieve the target range of fasting SMPG of 4.4 to 5.6 mmol/L | Drug: INSULIN GLARGINE (U300)<br>* Pharmaceutical form: pre-filled disposable pen Route of administration: subcutaneous<br>* Other names: HOE901;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching fasting SMPG ≤5.6 mmol/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with adverse events |  | 12 weeks |