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Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (GEMELLI X)

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ClinicalTrials.gov Identifier: NCT03874715
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus also using insulin glargine.

Secondary Objectives:

  • To compare the effects of alternating administration of SAR341402 and NovoLog with continuous use of NovoLog on immunogenicity.
  • To evaluate the safety of alternating administration of SAR341402 and NovoLog versus continuous use of NovoLog.
  • To compare other PK parameters between the two treatment arms (alternating administration of SAR341402 and NovoLog and continuous use of NovoLog).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin Aspart SAR341402 Drug: Insulin Aspart Drug: Insulin glargine U100 Phase 3

Detailed Description:
The study duration per participant is approximatively 18 weeks and 1 day including an up to 2-week screening period, a 16-week treatment period and 1-day post-treatment follow-up period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® Versus Continuous Use of NovoLog in Participants With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Switching arm: Alternative use of SAR341402 and NovoLog
Alternating use of SAR341402 and NovoLog, self-administered by subcutaneous injection at mealtime, starting with NovoLog for the first 4 weeks, then SAR341402 for 4 weeks, followed by NovoLog for 4 weeks and then SAR341402 for the last 4 weeks on top of Lantus as basal insulin.
Drug: Insulin Aspart SAR341402
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Drug: Insulin Aspart
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Other Name: NovoLog

Drug: Insulin glargine U100
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Other Name: Lantus

Active Comparator: Non-Switching arm: NovoLog
Continuous use of NovoLog, self-administrated by subcutaneous injection at mealtime, during the 16-week Treatment Period on top of Lantus as basal insulin.
Drug: Insulin Aspart
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Other Name: NovoLog

Drug: Insulin glargine U100
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Other Name: Lantus




Primary Outcome Measures :
  1. Similarity in pharmacokinetics (PK) of SAR341402 and NovoLog:AUClast [ Time Frame: Week 16 ]
    AUClast (area under the time-concentration curve from time zero to the time of the last concentration above the lower limit of quantification) following injection of a predefined, fixed dose of SAR341402 or NovoLog at Week 16

  2. Similarity in pharmacokinetics (PK) of SAR341402 and NovoLog: AUC [ Time Frame: Week 16 ]
    AUC (area under the concentration curve) following injection of a predefined, fixed dose of SAR341402 or NovoLog at Week 16

  3. Similarity in pharmacokinetics (PK) of SAR341402 and NovoLog: Cmax [ Time Frame: Week 16 ]
    Cmax (maximum concentration) following injection of a predefined, fixed dose of SAR341402 or NovoLog at Week 16


Secondary Outcome Measures :
  1. Immunogenicity: Anti-Insulin aspart antibody status (positive/negative) [ Time Frame: Baseline, Week 8, Week 12 and Week 16 ]
    Number of participants by anti-Insulin aspart antibody status (positive/negative) at baseline, Week 8, Week 12 and Week 16

  2. Safety: Hypoglycemic event [ Time Frame: Baseline to Week 16 ]
    Number of participants with at least one hypoglycemic event

  3. Safety: Number of hypoglycemic events per participant per year [ Time Frame: Baseline to Week 16 ]
    Number of hypoglycemic events per participant-year

  4. Safety: Adverse Events [ Time Frame: Baseline to Week 16 ]
    Number of participants with adverse events

  5. Comparison of PK parameters between the two arms (alternating administration of SAR341402 and NovoLog and continuous use of NovoLog) [ Time Frame: Week 16 ]
    Time to Cmax (Tmax) following injection of a predefined, fixed dose of SAR341402 or NovoLog at Week 16



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participants with type 1 diabetes mellitus.
  • Participants on continuous insulin treatment for at least 12 months prior to screening.
  • Participants on a multiple (≥3) daily injection insulin regimen using NovoLog as mealtime insulin and insulin glargine (100 U/mL) as basal insulin for at least 3 months prior to screening.
  • Glycated hemoglobin (HbA1c) below 10% (85.79 mmol/mol) (inclusive) at screening.
  • Body mass index (BMI) ≤35 kg/m² at screening.

Exclusion criteria:

  • Pancreatectomy and/or islet cell transplantation.
  • Clinically significant laboratory findings, as defined by the protocol.
  • Known presence of factors that interfere with the HbA1c measurement.
  • History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening.
  • Hospitalization for recurrent diabetic ketoacidosis within 3 months prior to screening.
  • Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
  • Use of glucose lowering treatments other than the multiple dose injections (MDI) and basal insulin regimen (including use of insulin pump therapy), within 3 months prior to screening.
  • Participants having received systemic glucocorticoids (topical, nasal spray, inhaled or intra-articular applications are allowed) for one week or more within 3 months prior to screening.
  • Participants having received immunosuppressive agents within 6 months prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874715


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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United States, California
Investigational Site Number 8400001 Recruiting
Temecula, California, United States, 92591
Investigational Site Number 8400015 Recruiting
Ventura, California, United States, 93003
United States, Kentucky
Investigational Site Number 8400018 Recruiting
Lexington, Kentucky, United States, 40503
United States, Maryland
Investigational Site Number 8400003 Recruiting
Rockville, Maryland, United States, 20852-4267
United States, Michigan
Investigational Site Number 8400004 Recruiting
Flint, Michigan, United States, 48532
United States, Tennessee
Investigational Site Number 8400008 Recruiting
Chattanooga, Tennessee, United States, 37404
United States, Texas
Investigational Site Number 8400016 Recruiting
Mesquite, Texas, United States, 75149
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03874715     History of Changes
Other Study ID Numbers: EFC15178
U1111-1197-7811 ( Other Identifier: UTN )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs