Clinical trial NCT01658579: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
Official title: A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: * Up to 4-week screening period;
* 16-week open-label comparative efficacy and safety treatment period;
* 4-week post-treatment safety follow-up period.

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.

Primary outcomes:
measure: Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
timeFrame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Secondary outcomes:
measure: Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])
timeFrame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
measure: Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])
timeFrame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
measure: Evaluation of Diurnal Glucose Exposure, Variability, and Stability
timeFrame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
measure: 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
timeFrame: Weeks 7-8 in Period A and Weeks 15-16 in Period B
measure: Change in HbA1c From Baseline to Week 8 and 16
timeFrame: Baseline, Week 8, 16
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
timeFrame: Baseline, Week 8, 16
measure: Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16
timeFrame: Baseline, Week 8, 16
measure: Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16
timeFrame: Baseline, Week 8, 16
measure: Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Temecula
country: United States
facility: Investigational Site Number 840002
state: California
city: Minneapolis
country: United States
facility: Investigational Site Number 840001
state: Minnesota
city: Portland
country: United States
facility: Investigational Site Number 840003
state: Oregon
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Bergenstal RM, Bailey TS, Rodbard D, Ziemen M, Guo H, Muehlen-Bartmer I, Ahmann AJ. Comparison of Insulin Glargine 300 Units/mL and 100 Units/mL in Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles and Variability Using Morning or Evening Injections. Diabetes Care. 2017 Apr;40(4):554-560. doi: 10.2337/dc16-0684. Epub 2017 Jan 23.