Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan (NEWLAN)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: INSULIN GLARGINE

Study type

Interventional

Funder types

Industry

Identifiers

NCT02606357

U1111-1172-1002 (Other Identifier)

LANTUL07225

Details and patient eligibility

About

Primary Objective:

-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).

Secondary Objectives:

To evaluate the percentage of patients achieving target of HbA1c ˂7%.
To evaluate the change in fasting plasma glucose (FPG).
To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.

Full description

The total duration of study period per patient is up to 6 months.

Enrollment

242 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

Patient ≥ 18 years old.
Male or Female.
Type 2 diabetes patients.
Uncontrolled with previous therapy (HbA1c >7%), evident in HbA1c test within the last 1 month before study entry.
Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.
Signed informed consent.
Signed informed consent.

Exclusion criteria:

Patient not willing or not able to perform self-monitoring blood glucose.
Patient not willing or not able to self-titrate insulin glargine under physician's guidance.
Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.
History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.
History of impaired renal function defined as serum creatinine >135 μmol/L (>1.525 mg/dL)in men and >110 μmol/L (>1.243 mg/dL) in women, evident in testing done in the last 3 months.
Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion).
Treatment with systemic corticosteroid within 3 months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.