Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Basal insulin · 1 trial · 1 indication
Subject safety measured by the number of Severe Adverse Events (SAEs)
System functionality measured by the generation of a recommended dose.
System functionality measured by the physician review and physician approval of daily dose recommendations in Phase 2.
System functionality measured by the subject-reported basal insulin dose injections.
-Measure of Average glucose (mg/dL)
\- Measure of CV (%)
\- Measure of TIR (70-180 mg/dL) (%)
\- Measure of Time spent very low (\<54 mg/dL) (%)
\- Measure of Time spent low (54-69 mg/dL) (%)
\- Measure of Time spent low (\<70 mg/dL) (%)
\- Measure of Time spent high (\>180 mg/dL) (%)
\- Measure of Time spent very high (\>250 mg/dL) (%)
Fasting Glucose
| Arm | Type | Description |
|---|---|---|
| Dexbasal | OTHER | Subjects initiating basal insulin therapy or on basal insulin therapy maintenance and benefit from transitioning to a study-specific type of basal insulin within 72 hours of Phase 1. |
| Name | Type | Description |
|---|---|---|
| Basal insulin | DRUG | daily basal insulin dose |
| Dexcom Continuous Glucose Monitoring (CGM) | DEVICE | Dexcom Continuous Glucose Monitoring (CGM) Sensor |
Inclusion Criteria: Patients with a diagnosis of Type 2 diabetes (T2D) mellitus * Ages equal or greater 18 years ("age" determined at the time of the Screening Visit) * Bodyweight between 30-450 kg * Comfortable with and willing to administer basal insulin injections, once a day, for approximately ...
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Basal insulin is being studied for use in people with Type 2 Diabetes. It is intended to help manage blood sugar levels by providing a steady background level of insulin. The drug is currently in Phase 1 clinical development and is being evaluated in a clinical trial in the United States.
Basal insulin is being developed by DexCom, Inc., a company traded on the NASDAQ under the ticker DXCM. DexCom is conducting clinical research on this drug for the treatment of Type 2 Diabetes.
Basal insulin is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is currently being studied in an active clinical trial that is not yet recruiting participants.
Basal insulin is being evaluated in a Phase 1 clinical trial with the identifier NCT07681375. The trial is titled 'Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 Sensor' and is being conducted in the United States with an enrollment of 45 participants.
No, Basal insulin is not the same as Dexcom G6. Basal insulin is an investigational drug being developed by DexCom, Inc. for Type 2 Diabetes. Dexcom G6 is a continuous glucose monitoring system, which is a device used to track glucose levels. The clinical trial for Basal insulin involves participants wearing a Dexcom G6 sensor.