Phase 3
Completed N=549
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01683266 ↗Enrolled (actual)
549
Serious AEs
9.7%
Results posted
Apr 2015
Primary outcomePrimary: Change In HbA1c From Baseline to Month 6 Endpoint — -0.40; -0.44 percentage of hemoglobin
Summary
Primary Objective:
* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus
Secondary Objective:
* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
* Change of HbA1c from baseline to endpoint (scheduled Month 6)
* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change In HbA1c From Baseline to Month 6 Endpoint |
-0.40; -0.44 | — |
| SECONDARY Percentage of Participants With HbA1c <7% at Month 6 Endpoint |
16.8; 15.0 | — |
| SECONDARY Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint |
8.1; 5.5 | — |
| SECONDARY Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint |
-1.16; -0.82 | — |
| SECONDARY Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint |
-3.03; -1.76 | — |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint |
-0.95; -1.14 | — |
| SECONDARY Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6 |
9.9; 12.8 | — |
| SECONDARY Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint |
25.3; 25.6 | — |
| SECONDARY Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint |
-0.47; -0.67; -0.86; -0.07; -0.62; -1.18 | — |
| SECONDARY Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint |
0.19; 0.10 | — |
| SECONDARY Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint |
1.00; 1.41 | — |
| SECONDARY Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 |
95.3; 94.9; 9.1; 11.3; 87.6; 86.5 | — |
Eligibility Criteria
Inclusion criteria
- Adult participants with type 1 diabetes mellitus
Exclusion criteria
- HbA1c less than ( ) 10% (86 mmol/mol) at screening
- Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
- Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
- Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
- Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
- Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
- Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period
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 (NCT01683266). 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.