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

Diabetes Mellitus, Type 2 Clinical Trial

— NEWLAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606357
• Other study ID #: LANTUL07225
• Secondary ID: U1111-1172-1002
• Status: Completed
• Phase: Phase 4
• Start date: November 22, 2015
• Est. completion date: November 27, 2017

Study information

• Verified date: October 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• INSULIN GLARGINE
Pharmaceutical form:Solution Route of administration: Subcutaneous

Locations

Country	Name	City	State
Jordan	JORDAN	Jordan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Jordan, 

Outcome

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