Trials / Suspended
SuspendedNCT02446028
A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes
A Randomized, Open-label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes
- Status
- Suspended
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Biodel · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to Humalog®Mix 75/25 in patients with type 2 diabetes.
Detailed description
BIOD-531 is a formulation of recombinant human insulin with a biphasic absorption profile characterized by rapid absorption (to prevent meal-time rises in blood glucose) and a secondary longer (basal) phase. The purpose of this trial is to evaluate glucose control and safety of BIOD-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIOD-531 | |
| DRUG | Humalog® Mix 75/25 |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2016-02-01
- Completion
- 2016-05-01
- First posted
- 2015-05-15
- Last updated
- 2016-04-07
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02446028. Inclusion in this directory is not an endorsement.