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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Without Continous Glucose Monitoring (CGM) sensor

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

Group Type ACTIVE_COMPARATOR

INSULIN GLARGINE (HOE901)

Intervention Type DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

INSULIN GLULISINE (HMR1964)

Intervention Type DRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Arm B: Continous Glucose Monitoring (CGM) sensor

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.

Group Type EXPERIMENTAL

INSULIN GLARGINE (HOE901)

Intervention Type DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

INSULIN GLULISINE (HMR1964)

Intervention Type DRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Interventions

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INSULIN GLARGINE (HOE901)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type DRUG

INSULIN GLULISINE (HMR1964)

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Run-in period:

1. Type 2 diabetes
2. HbA1c≥ 8.5% (in a test of the last month)
3. Age above 21 years
4. Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
5. Signed informed consent form
6. Patients who according to their physician are eligible to the study

Randomization:

1. HbA1c \> 7.5%
2. FPG \< 130 mg/dl

Exclusion Criteria

1. Type 1 diabetes
2. Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
3. Pregnant or breastfeeding women.
4. Patients with allergy to insulin.
5. Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
6. Patients with mobility difficulties and/or difficulties communicating with the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No