Phase 2
Completed N=59
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
Source: ClinicalTrials.gov NCT01658579 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
May 2015
Primary outcomePrimary: Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) — 31.75; 30.99 percentage of time — p=0.7304
Summary
Primary Objective:
* To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus
Secondary Objectives:
* To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
* To compare the incidence and frequency of hypoglycemic episodes
* To assess the safety and tolerability of the new formulation of insulin glargine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) |
31.75; 30.99 | 0.7304 |
| SECONDARY Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL]) |
58.24; 57.38 | — |
| SECONDARY Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL]) |
10.01; 11.64 | — |
| SECONDARY Evaluation of Diurnal Glucose Exposure, Variability, and Stability |
8.869; 8.910; 0.673; 0.703; 4.931; 5.279 | — |
| SECONDARY Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B |
32.08; 29.07; 33.02; 28.70 | — |
| SECONDARY Change in HbA1c From Baseline to Week 8 and 16 |
-0.22; -0.23; -0.44; -0.22 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16 |
-0.89; -0.10; -0.99; 0.78 | — |
| SECONDARY Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16 |
-0.39; 0.39; -0.47; 0.58 | — |
| SECONDARY Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16 |
0.06; 0.03; 0.05; 0.03 | — |
| SECONDARY Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16 |
100; 100; 3.3; 10.3; 93.3; 96.6 | — |
Eligibility Criteria
Inclusion criteria
- Participants with Type 1 diabetes mellitus
Exclusion criteria
- HbA1c greater than (>) 9% (at screening)
- Participants receiving >0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit
- Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit
- Less than 1 year on any basal plus mealtime insulin
- Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic 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;
- Any contraindication to use of insulin glargine as defined in the national product label
- Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening
- Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization
- Initiation of any glucose-lowering agents in the last 3 months before screening visit
- Weight change of greater than equal to (>=) 5 kg during the last 3 months prior to screening visit
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require 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 (NCT01658579). 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.