Recent Updates
Recently added Catalysts

Insuplant

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Sanofi|Last Updated: Feb 15, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment479

FDA Designations

No designations recorded

Clinical trial landscape

Insuplant · 1 trial · 1 indication

Phase 3 1
NCT01194882Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 DiabetesDiabetes Mellitus, Type 1
COMPLETED479 Analytics
PHASE3COMPLETED
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Refill accuracy between the 2 insulin groups
During 4 refill cycles
Change in glycosylated hemoglobin (HbA1c)
From baseline to 6 months

Secondary Endpoints

Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
From baseline to 6 months
Occurrence of hyperglycaemia
From baseline to 6 months
Occurrence of diabetic ketoacidosis
From baseline to 6 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insuman ImplantableEXPERIMENTALStarting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines.
InsuplantACTIVE_COMPARATORStarting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines.

Interventions

NameTypeDescription
HUMAN INSULIN (BIOSYNTHETIC)DRUGPharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
InsuplantDRUGPharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen:
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion criteria: 1. Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007 2. Glycosylated hemoglobin ≤9.0% 3. Patient showing a percentage of error at refill equal or below 20% 4. Patient undergoing NaOH rinse procedure of at least 10 minutes period with or wi...

Countries:BelgiumFranceNetherlandsSweden
Unlock Eligibility Criteria

Frequently asked questions about Insuplant

What is Insuplant used for?

Insuplant is an investigational small molecule being developed by Sanofi for the treatment of Type 1 Diabetes Mellitus. It is designed for use with an implantable pump system to deliver insulin therapy. As of the available data, it is in Phase 3 clinical development and is not yet approved.

What does Insuplant target?

Insuplant is a small molecule intended for use in Type 1 Diabetes Mellitus. The available information does not specify a molecular target or target class for Insuplant. It is being evaluated in a Phase 3 clinical trial for its benefit and risk profile when used with an implantable pump system.

Who makes Insuplant?

Insuplant is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of Insuplant in patients with Type 1 Diabetes Mellitus.

What phase is Insuplant in?

Insuplant is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial, NCT01194882, has been completed, evaluating the benefit and risk of Insuplant compared to an active control in patients with Type 1 Diabetes.

What clinical trials is Insuplant in?

Insuplant has been studied in one Phase 3 clinical trial, NCT01194882, titled 'Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes'. This trial was completed and enrolled 479 participants across Belgium, France, Netherlands, and Sweden.

Is Insuplant the same as Insuman Implantable?

Insuplant is being compared to Insuman Implantable in a clinical trial, but they are not the same drug. The trial evaluates the benefit and risk of Insuman Implantable versus Insuplant, both used with the Medtronic MiniMed implantable pump system in patients with Type 1 Diabetes. Insuplant is a separate investigational product.