6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents age 6 - 17 years with Type 1 Diabetes Mellitus with a 6-month Safety Extension Period
Study ID: STU 122015-057
This is a multicenter, randomized, open label study to assess the long-term safety, pharmacodynamics, pharmacokinetics, and efficacy of the study drug, Hoe901-u300, given once daily by injection. This will be compared with daily injections of Lantus in children and adolescents ages 6-17 diagnosed with T1DM for at least 1 year. if eligible, subjects will be involved in the study for approximately 58 weeks with at least 7 scheduled clinic visits and at least 13 telephone visits. Four of the five morning visits to clinic will be fasting. a total between 43 cc's and 46 cc's of blood will be drawn during the total study participation, depending on whether the subject participates in pharmacokinetic (PK) testing. Subjects will also have the ability to participate in a CGM sub-study. at Visit 3, the subjects will be randomized to receive during the 6 month treatment period and the 6 month extension period either the study drug Hoe901-u300 or Lantus at a 1:1 ratio. at this visit, subjects must be between the ages of 6 and 17 years old. The randomization is stratified by Hba1c at screening ([Less Than]8.5 versus [GreaterThanorequalTo] 8.5%) and by age group ( [Less Than]12 years old versus [GreaterThanorequalTo] 12 years old). efforts will be made to enroll at least 30% of the participants in the age range of [Less Than] 12 years old. The primary efficacy endpoint is the change of Hba1c from baseline to main 6 month endpoint. The Hba1c reflects the average glycemia over 2-3 months and has a strong predictive value for diabetes complications. The following secondary safety endpoints will be assessed: hypoglycemia, hyperglycemia with ketosis, adverse events (ae), serious adverse events (Sae), adverse event of special interest (aeSi), safety lab values (hematology, chemistry, urinalysis, c-peptide, serum pregnancy test, hepatitis C), anti-insulin antibodies, physical examination with Tanner staging, vital signs including blood pressure and heart rate, and body weight and height. one mL of blood at 3 separate blood draws will be collected for PK testing at the end of the titration phase (no sooner than Visit 13, Week 20 but not later than Visit 14, Week 26) from study participants who volunteer to participate in a single PK lab draw. Patients will be offered to stay at the study site thoughout the day while the lab draw procedures are being performed. Meals will be provided. The times of the lab draws (3) will be determined by the existing basal insulin dosing regimen.
A subject must meet all the following inclusion criteria to be able to participate in this study: 1. Male or female ages 6-17 years old at V3, randomization visit. 2. Diagnosis of Type 1 Diabetes for at least 12 months confirmed by typical symptoms, and/or by antibody testing (presence of anti-GAD [glutamic acid decarboxylase] or anti-IA2 [insulin antigen 2], or anti-islet cell antibodies), and/or clinical features (eg, history of ketoacidosis). 3. Signed written informed consent obtained from parent (s)/legal guardian and written or oral assent from patient.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- Soumya Adhikari
SANOFI US SERVICES INC