Phase 3
Completed N=811
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Source: ClinicalTrials.gov NCT01499095 ↗Enrolled (actual)
811
Serious AEs
7.4%
Results posted
Apr 2015
Primary outcomePrimary: Change in HbA1c From Baseline to Month 6 Endpoint — -0.57; -0.56 percentage of hemoglobin
Summary
Primary Objective:
* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus
Secondary Objective:
* 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 |
-0.57; -0.56 | — |
| SECONDARY Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint |
21.6; 27.9 | 0.0380 sig |
| SECONDARY Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint |
-0.56; -0.51 | 0.8279 |
| SECONDARY Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint |
-2.34; -0.53 | — |
| SECONDARY Percentage of Participants With HbA1c <7% at Month 6 Endpoint |
30.6; 30.4 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint |
-1.03; -1.21 | — |
| SECONDARY Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint |
29.4; 33.6 | — |
| SECONDARY Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint |
-0.56; -0.90; -1.31; -1.81; -1.41; -1.82 | — |
| SECONDARY Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint |
0.28; 0.17 | — |
| SECONDARY Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint |
3.05; 3.61 | — |
| SECONDARY Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 |
79.9; 83.0; 1.7; 1.5; 58.8; 63.3 | — |
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 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
- Participants using sulfonylurea in the last 2 months before screening visit
- Any contraindication to use of insulin glargine as defined in the national product label
- Use of insulin pump in the last 6 months before screening
- Initiation of new glucose-lowering medications 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 (NCT01499095). 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.