---
title: Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons
nct_id: NCT02403648
overall_status: COMPLETED
phase: PHASE1
sponsor: Biodel
study_type: INTERVENTIONAL
primary_condition: Hypoglycemia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02403648.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02403648"
ct_last_update_post_date: 2016-01-15
last_seen_at: "2026-05-12T06:44:36.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

**Official Title:** Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Glucagon for Injection (Eli Lilly) and GlucaGen® (Novo Nordisk) Administered by Subcutaneous and Intramuscular Injection in Normal, Healthy Volunteers

**NCT ID:** [NCT02403648](https://clinicaltrials.gov/study/NCT02403648)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** Biodel
- **Conditions:** Hypoglycemia
- **Start Date:** 2014-11
- **CT.gov Last Update:** 2016-01-15

## Brief Summary

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.

## Detailed Description

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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Body Mass Index: 18.5-25.0 kg/m2 inclusive.
* Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.

Exclusion Criteria:

* Type 1 or type 2 diabetes mellitus.
* History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease.
* History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor.
* Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease.
* Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack.
* Females who are breast feeding, pregnant, or intending to become pregnant during the study.
```

## Arms

- **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.

## Interventions

- **BIOD-961** (DRUG) — BIOD-961 is a lyophilized glucagon formulation.
- **Lilly Glucagon** (DRUG)
- **Novo Glucagon** (DRUG)

## Primary Outcomes

- **Glucagon maximal concentration and area under curve** _(time frame: 240 minutes post dose)_
- **Glucose maximal concentration and area under curve** _(time frame: 240 minutes after dose)_

## Secondary Outcomes

- **Time to maximal glucagon concentration** _(time frame: 240 minutes after dose)_
- **Time to maximal glucose concentration** _(time frame: 240 minutes after dose)_
- **Maximal glucose excursion** _(time frame: 240 minutes after dose)_
- **Area under the glucose time curve from 0 to return to baseline after blood glucose peaked** _(time frame: 240 minutes after dose)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02403648.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02403648*  
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