Phase 3
Completed N=807
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
Source: ClinicalTrials.gov NCT01499082 ↗Enrolled (actual)
807
Serious AEs
14.3%
Results posted
Apr 2015
Primary outcomePrimary: Change in HbA1c From Baseline to Month 6 Endpoint — -0.83; -0.83 percentage of hemoglobin
Summary
Primary Objective:
* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus
Secondary Objectives:
* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Month 6 Endpoint |
-0.83; -0.83 | — |
| SECONDARY Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint |
36.1; 46.0 | 0.0045 sig |
| SECONDARY Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint |
-0.90; -0.84 | 0.6909 |
| SECONDARY Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint |
-1.10; -1.08 | — |
| SECONDARY Percentage of Participants With HbA1c <7% at Month 6 Endpoint |
39.6; 40.9 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint |
-1.29; -1.38 | — |
| SECONDARY Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint |
26.5; 23.2 | — |
| SECONDARY Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint |
-0.98; -1.16; -1.19; -1.49; -1.60; -1.90 | — |
| SECONDARY Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint |
0.28; 0.19 | — |
| SECONDARY Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint |
2.32; 2.24 | — |
| SECONDARY Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 |
87.4; 92.0; 6.7; 7.5; 74.8; 82.8 | — |
Eligibility Criteria
Inclusion criteria
- Participants with type 2 diabetes mellitus
- Substudy inclusion criteria:
- Completion of the 6-month study period in main study (Visit 10)
- Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)
Exclusion criteria
- Age less than ( ) 10% at screening
- Diabetes other than type 2 diabetes mellitus
- Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
- Any contraindication to use of insulin glargine as defined in the national product label
- Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
- Use of an insulin pump in the last 6 months before screening visit
- Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit
- History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
- Pregnant or breast-feeding women or women who intend to become pregnant during the study period
- Substudy exclusion criteria:
- Participant not willing to use the adaptable injection intervals on at least two days per week
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01499082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.