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: M11 Report Section 6 (Trial Intervention) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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      <div xmlns="http://www.w3.org/1999/xhtml"><p>This study involves a comparison of 3 mg of LY900018 administered once nasally to 1 mg glucagon administered IM (comparator). Table IGBJ.2 shows the study treatment information. Table IGBJ.2 Study Treatments Treatment Name LLY900018 GlucaGen Dosage Formulation Dry powder Dry powder Dosage Levels 3 mg glucagon 1 mg glucagon Route of Administration Intranasal Intramuscular Dosing Instructions Administer a single nasal dose Administer a single intramuscular upon hypoglycemia onset injection upon hypoglycemia onset.</p></div>
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        <div xmlns="http://www.w3.org/1999/xhtml"><p>The procedure for insulin-induced hypoglycemia will require an IV infusion of diluted human regular insulin (0.3 U/mL by diluting 15 U human regular insulin [100 U/mL] into 50 mL saline). Details regarding hypoglycemia induction and glucagon administration procedures are included in Sections 9.2.1 and 9.2.2, respectively. The investigator or designee is responsible for: • explaining the correct use of the investigational products to the site personnel • verifying that instructions are followed properly • maintaining accurate records of investigational product dispensing and collection • and returning all unused medication to Lilly or its designee at the end of the stud The manufactured drug product provided for use in the study includes a nasal delivery device as part of the investigational drug product. The device component of the investigational drug product is inserted into the nasal cavity to deliver the contained drug constituent. The hypoglycemia induction procedure should be initiated at approximately the same time at each treatment visit. Insulin IV infusion will be given until PG is &lt; 60 mg/dL. At this point, insulin infusion will be stopped and, approximately 5 minutes later, a single glucagon dose (LY900018 or IMG) will be administered. The doses will be administered at approximately the same times on each day. The actual time of all dose administrations will be recorded in the patient’s case report form (CRF).</p></div>
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          <div xmlns="http://www.w3.org/1999/xhtml"><p>Prior to the study drug administration on Period 1 Day 1, patients will be randomly assigned to a treatment sequence (either LY900018 in Period 1 and IMG in Period 2, or vice versa).</p></div>
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          <div xmlns="http://www.w3.org/1999/xhtml"><p>The following concomitant medications are prohibited to use during the course of the study: beta-blocker, indomethacin, warfarin, and anti-cholinergic drugs. The following concomitant medications that affect gastric motility can be used during the study but should be washed out before 7 days of each period and not taken while in the CRU: pro-motility medications (eg, metoclopramide, domperidone), opiate medications (eg, morphine), and medications with anti-emetic effects (eg, promethazine, prochlorperazine). In general, concomitant medication should be avoided; however, acetaminophen (1 g, maximum 2 g/24 hours) may be administered at the discretion of the investigator for treatment of headaches, etc. If the need for concomitant medication (other than acetaminophen) arises, inclusion or continuation of the patients may be at the discretion of the investigator after consultation with a Lilly clinical pharmacologist (CP) or CRP. Any medication used during the course of the study must be documented.</p></div>
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          <div xmlns="http://www.w3.org/1999/xhtml"><p>Patients on stable concomitant medication at the time of study entry should continue their regular, unchanged dose throughout the study. These medications include stable regimen for 3 months of the anti-hyperglycemic therapy (for example, insulins and OAMs) as well as anti-hypertensive and anti-lipidemic medications. In addition to the physical examination, investigators should review the insulin regimen for all patients enrolled into the study to confirm acceptability to undergo the procedure to induce hypoglycemia (see Schedule of Activities; Section 2). For patients using basal insulin, the last basal insulin injection should occur no later than 12 hours prior to the insulin-induced hypoglycemia procedure, and the basal dose should not be changed. Patients may inject basal insulin any time after the last PK sample is collected on Day 1 in each period. For patients using prandial insulin, the last prandial insulin injection should occur no later than 6 hours prior to the insulin-induced hypoglycemia procedure. Patients may inject prandial insulin after the last PK sample is collected and before the meal on Day 1 in each period. The first prandial insulin dose for an individual patient after insulin-induced hypoglycemia procedure should be determined by the investigator based on the PG before meal and carbohydrate intake. For patients using an insulin pump, a continuous subcutaneous insulin infusion by pump should be discontinued prior to procedure to induce hypoglycemia. Patients may start subcutaneous insulin infusion after the last PK sample is collected and before the meal on Day 1 in each period. The insulin dose should be determined by the investigator based on the PG before meal and carbohydrate intake. For patients using OAMs, the last dose should occur no later than 12 hours prior to the insulin-induced hypoglycemia procedure. Patients may start OAM after the last PK sample is collected on Day 1 in each period</p></div>
        </text>
      </section>
    </section>
  </section>
</Composition>