Clinical Trial Details

Overview

Research Study Summary

LPS 14347 Achieve Control Real Life Study Program

Purpose

A randomized, open-label, parallel group real world pragmatic trial to assess the clinical and health outcomes of Toujeo® compared to commercially available basal insulins for initiation of therapy in insulin naïve patients with uncontrolled type 2 diabetes mellitus.

To Learn more

CW ID: 220613
Date Last Changed: November 7, 2016

Clinical Trial Snapshot

Phase
4
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Sanofi US
Duration
53 Weeks
Facility Type
N/A

Eligibility

Primary Inclusion: INCLUSION CRITERIA

  • Patients with type 2 diabetes (T2DM), as defined by the ADA/WHO, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, DPP-4 inhibitors, or SGLT-2 inhibitors) or GLP-1 receptor agonists approved for use with insulin.

EXCLUSION CRITERIA:

  • HbA1c < 8.0% or >11.0%.
  • Males or females < 18 years of age.
  • Type 1 diabetes mellitus
  • Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, Afrezza) since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization occurring more than 3 months prior to the time of screening.
  • Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening.
  • All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.
  • Pregnant or breastfeeding woman.
  • Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy.

Contact

Denise Esparza, Senior Clinical Research Coordinator
Diabetes Associates Medical Group / Clinical Research
1234 W. Chapman Ave., Suite 106
Orange, CA 92868
Phone: 714-202-8894
Fax: 714-639-3904

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