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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: INSULIN GLARGINE

• Registration Number: NCT02606357
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Study Start: 2015-11-22
• Primary Completion: 2017-11-27
• Study Completion: 2017-11-27
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Baseline, 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

JORDAN; 🇯🇴 Jordan, Jordan