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BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.
Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOD-961, 1 mg IM | Experimental | Intramuscular delivery of BIOD-961. |
|
| Lilly Glucagon, 1 mg IM | Active Comparator | Intramuscular delivery of Lilly glucagon. |
|
| Novo Glucagon, 1 mg IM | Active Comparator | Intramuscular delivery of Novo glucagon. |
|
| BIOD-961, 1 mg SC | Experimental | Subcutaneous delivery of BIOD-961, |
|
| Lilly Glucagon, 1 mg SC | Active Comparator | Subcutaneous delivery of Lilly glucagon. |
|
| Novo Glucagon, 1 mg SC | Active Comparator | Subcutaneous delivery of Novo glucagon. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOD-961 | Drug | BIOD-961 is a lyophilized glucagon formulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon maximal concentration and area under curve | 240 minutes post dose | |
| Glucose maximal concentration and area under curve | 240 minutes after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximal glucagon concentration | 240 minutes after dose | |
| Time to maximal glucose concentration | 240 minutes after dose | |
| Maximal glucose excursion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Morrow, MD | Profil Institute for Clinical Research, Inc. | Principal Investigator |
| Alan Krasner, MD | Biodel | Study Director |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Lilly Glucagon | Drug |
|
| Novo Glucagon | Drug |
|
| 240 minutes after dose |
| Area under the glucose time curve from 0 to return to baseline after blood glucose peaked | 240 minutes after dose |