Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM) (B to B)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: INSULIN GLULISINE; Drug: INSULIN GLARGINE; Drug: Insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01212913

LANTU_L_04867

U1111-1117-2786 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.

Secondary Objective:

To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:

   • Sub-optimal: HbA1c level >7% and fasting blood glucose <130mg/dL

2. Male or Female ≥18 years old

3. Body Mass Index (BMI) <40

4. 10% ≥HbA1c ≥7%

5. If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months

6. Patients willing to sign data release consent form

Exclusion criteria

1. Diabetes other than T2DM
2. Enrolled in other clinical trials
3. Previous treatment with an insulin other than insulin glargine
4. Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors
5. Pregnant or lactating women
6. Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart)
7. Treatment with systemic corticoid steroids within the last 3 months prior to study enter
8. Treatment with any investigational product within the last 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

group 1: Basal plus

Experimental group

Description:

Insulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG)

Treatment:

Drug: INSULIN GLARGINE

Drug: INSULIN GLULISINE

group 2: Biphasic insulin

Active Comparator group

Description:

Insulin aspart/insulin aspart protamine 30/70 (novomix 30) given twice daily and titrated weekly (before breakfast and dinner) according to the lowest of three previous days' pre-meal levels (both breakfast and dinner). Target is 70 mg/dL \< Pre-meal blood glucose (dinner and breakfast).

Treatment:

Drug: Insulin aspart