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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02606357
• Date of registration: 13/11/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan NEWLAN
• Scientific title: Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
• Date of first enrolment: November 22, 2015
• Target sample size: 242
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02606357
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Jordan

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: INSULIN GLARGINE

Primary Outcome(s)

Change from baseline in HbA1c [Time Frame: Baseline, 6 months]

Secondary Outcome(s)

- Percentage of patients achieving target of HbA1c <7% [Time Frame: 6 months]

- Time to reach control [Time Frame: 6 months]

- Number of patients with adverse events [Time Frame: Baseline, 6 months]

- Change from baseline in body weight [Time Frame: Baseline, 3 months and 6 months]

- Change from baseline in fasting plasma glucose values [Time Frame: Baseline, 3 months, and 6 months]

- Change in dose of insulin glargine [Time Frame: 3 months and 6 months]

- Change in the titration doses used (if any) [Time Frame: 6 months]

- Percentage of patients with hypoglycemic events [Time Frame: Baseline, 6 months]

Secondary ID(s)

U1111-1172-1002

LANTUL07225

Source(s) of Monetary Support

Please refer to primary and secondary sponsors