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A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

Principal Investigator

Bresta Miranda-Palma

Clinical Trial ID

Institutional Protocol # 20150340
National Clinical Trials Identifier NCT02451137

Clinical Trial Summary


Phase

Phase 4


Funding Agency/Sponsor

Industry


Disease

Diabetes (Type II)


Enrollment Eligibility

Inclusion criteria :
- Patients with T2DM, as defined by the American Diabetes Association/World Health
Organization, 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, dipeptidyl
peptidase-4 [DPP-4] inhibitors, or sodium-glucose cotransporter 2 [SGLT-2] inhibitors)
or glucagon-like peptide-1 (GLP-1) receptor agonists approved for use with insulin.
- Adult patients who have signed an Informed Consent Form and Health Insurance
Portability and Accountability Act (HIPAA) Authorization Form.
Exclusion criteria:
- HbA1c <8.0% or >11.0%.
- Males or females <18 years of age.
- Type 1 diabetes mellitus.
- Any clinically significant abnormality identified on physical examination, laboratory
tests, or vital signs at the time of screening, or any major systemic disease
resulting in short life expectancy that in the opinion of the Investigator would
restrict or limit the patient's successful participation for the duration of the
study.
- Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog,
Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than
temporary use during pregnancy or hospitalization.
- Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog,
Novolog, Apidra, or Afrezza) occurring within 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, or 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.
- Pregnancy or lactation.
- Women of childbearing potential with no effective contraceptive method.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.


Contact Information

Study Contact Burlett Masters
Phone Number 305-243-5354
Get detailed information on ClinicalTrials.Gov