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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, Long-Acting; Protamines

Criteria

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.