CompletedNot Applicable

Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

Colombia4,589 participantsStarted 2018-03-06

Plain-language summary

Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives: * Assess effectiveness in achieving glycemic goal measured by HbA1c; * Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; * Assess requirement for intensification of therapy by additional antidiabetics. * Assess incidence of hypoglycemia; * Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); * Assess change in body weight.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria : * Signed patient informed consent; * Type 2 diabetes mellitus; * Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months; * Hemoglobin A1c (HbA1c) \>7.0 % and ≤11% within 3 months of study baseline; * Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen Exclusion criteria: * Diabetes mellitus other than type 2; * Contraindication to insulin glargine U300 according to local product labelling; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

What they're measuring

Change in HbA1c at month 6

Timeframe: Baseline, month 6

Trial details

NCT IDNCT03703869

SponsorSanofi

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-06-28

View on ClinicalTrials.gov More Diabetes trials