Clinical trial NCT01212913: Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)
Official title: Comparison of a Basal Plus (Insulin Glargine/Insulin Glulisine) Regimen to Biphasic Insulin (InsulinAspart/Insulin Aspart Protamine 30/70) in T2DM Patients Who Require Insulin Intensification After Basal Insulin Optimization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-10-01
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change in hemoglobin A1c level (HbA1c)
timeFrame: At 6 months of treatment
Secondary outcomes:
measure: Rate of hypoglycemic events (total, severe, nocturnal)
timeFrame: from baseline to the study endpoint (over 6 months of treatment)
measure: Proportion of patients with HbA1c < 7%
timeFrame: from baseline to the study endpoint (over 6 months of treatment)
measure: Change in body weight
timeFrame: from baseline to the study endpoint (over 6 months of treatment)
measure: Reactive Oxidative Stress (ROS) level changes
timeFrame: from baseline to the study endpoint (over 6 months of treatment)
measure: Change in Quality of Life
timeFrame: from baseline to the study endpoint (over 6 months of treatment)
measure: Continuous Glucose Monitoring System (CGMS) data
timeFrame: at baseline, 3 and 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Jin SM, Kim JH, Min KW, Lee JH, Ahn KJ, Park JH, Jang HC, Park SW, Lee KW, Won KC, Kim YI, Chung CH, Park TS, Lee JH, Lee MK. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24-week randomized non-inferiority trial. J Diabetes. 2016 May;8(3):405-13. doi: 10.1111/1753-0407.12312. Epub 2015 Jun 29.