Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: INSULIN GLARGINE (HOE901); Drug: INSULIN GLULISINE (HMR1964)

• Registration Number: NCT01234597
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen

Detailed Description

The study duration for each patient is 24 weeks +/- 1 week broken down as follows:

* Run-in phase: 8 weeks

* Follow - up Period: 16 weeks

The maximal possible time window during the study is +/- one week throughout the study.

Study Timeline

• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Study Start: 2012-12
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Without Continous Glucose Monitoring (CGM) sensor	INSULIN GLARGINE (HOE901)	Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician
Arm A: Without Continous Glucose Monitoring (CGM) sensor	INSULIN GLULISINE (HMR1964)	Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician
Arm B: Continous Glucose Monitoring (CGM) sensor	INSULIN GLARGINE (HOE901)	Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring.
Arm B: Continous Glucose Monitoring (CGM) sensor	INSULIN GLULISINE (HMR1964)	Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring.

Primary Outcome Measures

Name	Time	Method
Changes in Hemoglobin A1c (HbA1c) level	Baseline, week 24

Secondary Outcome Measures

Name	Time	Method
Changes in insulin glulisine dose	Baseline, week 24
Rate of hypoglycemia	Week 24
Changes in insulin glargine dose	Baseline, week 24

Trial Locations

Locations (11)

Investigational Site Number 376010; 🇮🇱 Tel-Aviv, Israel

Investigational Site Number 376006; 🇮🇱 Netanya, Israel

Investigational Site Number 376009; 🇮🇱 Sachnin, Israel

Investigational Site Number 376008; 🇮🇱 Tel Aviv, Israel

Investigational Site Number 376012; 🇮🇱 Lod, Israel

Investigational Site Number 376003; 🇮🇱 Beer Sheva, Israel

Investigational Site Number 376007; 🇮🇱 Haifa, Israel

Investigational Site Number 376001; 🇮🇱 Ramat-Gan, Israel

Investigational Site Number 376013; 🇮🇱 Nazareth, Israel

Investigational Site Number 376004; 🇮🇱 Kfar Saba, Israel

Investigational Site Number 376011; 🇮🇱 Tel-aviv, Israel