Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus
Intervention: HOE901-U300 (new formulation of insulin glargine) (Drug); Lantus (insulin glargine) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
Secondary outcome: Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL]) Evaluation of Diurnal Glucose Exposure, Variability, and Stability 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 Change in HbA1c From Baseline to Week 8 and 16 Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16 Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16 Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16 Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Investigational Site Number 840002, Temecula, California 92591, United States
Investigational Site Number 840001, Minneapolis, Minnesota 55416, United States
Investigational Site Number 840003, Portland, Oregon 97201-3098, United States
Additional Information
Starting date: August 2012
Last updated: May 7, 2015
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