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 (SeLan)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: INSULIN GLULISINE (HMR1964); Drug: INSULIN GLARGINE (HOE901)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01234597

LANTU_L_05146

U1111-1116-2926 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

219 participants in 2 patient groups

Arm A: Without Continous Glucose Monitoring (CGM) sensor

Active Comparator group

Description:

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

Treatment:

Drug: INSULIN GLARGINE (HOE901)

Drug: INSULIN GLULISINE (HMR1964)

Arm B: Continous Glucose Monitoring (CGM) sensor

Experimental group

Description:

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.

Treatment:

Drug: INSULIN GLARGINE (HOE901)

Drug: INSULIN GLULISINE (HMR1964)