Clinical trial NCT02606357: Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan
Official title: Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility 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.

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: - Percentage of patients achieving target of HbA1c <7%
timeFrame: 6 months
measure: - Change from baseline in fasting plasma glucose values
timeFrame: Baseline, 3 months, and 6 months
measure: - Percentage of patients with hypoglycemic events
timeFrame: Baseline, 6 months
measure: - Change from baseline in body weight
timeFrame: Baseline, 3 months and 6 months
measure: - Number of patients with adverse events
timeFrame: Baseline, 6 months
measure: - Change in dose of insulin glargine
timeFrame: 3 months and 6 months
measure: - Change in the titration doses used (if any)
timeFrame: 6 months
measure: - Time to reach control
timeFrame: 6 months
Other outcomes:
Locations:
city: Jordan
country: Jordan
facility: JORDAN
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: