LPS 14347 Achieve Control Real Life Study Program

  • STATUS
    Recruiting
  • sponsor
    Sanofi US
Updated on 25 March 2021

Summary

LPS 14347 Achieve Control Real Life Study Program

Description

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.

Details
Condition Diabetes Mellitus, Type 2, Diabetes Mellitus Types I and II
Clinical Study IdentifierTX146021
SponsorSanofi US
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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