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

NCT ID: NCT02606357

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-22
• Study Completion Date: 2017-11-27

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HOE901

HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels

Group Type: EXPERIMENTAL

INSULIN GLARGINE

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Subcutaneous

Interventions

INSULIN GLARGINE

Pharmaceutical form:Solution

Route of administration: Subcutaneous

Intervention Type: DRUG

Other Intervention Names

HOE901

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

JORDAN

Jordan, , Jordan

Countries

Jordan

Other Identifiers

U1111-1172-1002

Identifier Type: OTHER

Identifier Source: secondary_id

LANTUL07225

Identifier Type: -

Identifier Source: org_study_id