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

Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: INSULIN GLARGINE

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 4

Contacts and Locations

Study Locations

• Jordan
  • Jordan, Jordan
    • JORDAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HOE901; HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels	Drug: INSULIN GLARGINE; Pharmaceutical form:Solution Route of administration: Subcutaneous; Other Names: HOE901

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
- Percentage of patients achieving target of HbA1c <7%	6 months
- Change from baseline in fasting plasma glucose values	Baseline, 3 months, and 6 months
- Percentage of patients with hypoglycemic events	Baseline, 6 months
- Change from baseline in body weight	Baseline, 3 months and 6 months
- Number of patients with adverse events	Baseline, 6 months
- Change in dose of insulin glargine	3 months and 6 months
- Change in the titration doses used (if any)	6 months
- Time to reach control	6 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2015
• Primary Completion (Actual): November 27, 2017
• Study Completion (Actual): November 27, 2017

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: LANTUL07225; U1111-1172-1002 (Other Identifier: UTN)