Status:
COMPLETED
Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500
Lead Sponsor:
Biodel
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The study is to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.
Eligibility Criteria
Inclusion
- Age 18-65
- BMI \> 25 kg/m2
- Type 2 Diabetes Mellitus
- HbA1c \< 10.0%
- Subject uses 50-200 units of insulin/day
Exclusion
- Type 1 Diabetes Mellitus
- History of bariatric surgery
- Corticosteroid therapy
- Significant cardiovascular or other major organ disease
- Females who are breast feeding or pregnant
- A sexually active person not using adequate contraceptive methods
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02212951
Start Date
May 1 2014
Last Update
February 8 2016
Active Locations (1)
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1
Profil Institute for Clinical Research
Chula Vista, California, United States