Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500
NCT ID: NCT02212951
Last Updated: 2016-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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BIOD-531 pre-meal
Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
BIOD-531
Humalog Mix 75/25 pre-meal
Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
Humalog Mix 75/25
Humulin R U-500
Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast
Humulin R U-500
BIOD-531 post-meal
Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast
BIOD-531
Interventions
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BIOD-531
Humalog Mix 75/25
Humulin R U-500
Eligibility Criteria
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Inclusion Criteria
* BMI \> 25 kg/m2
* Type 2 Diabetes Mellitus
* HbA1c \< 10.0%
* Subject uses 50-200 units of insulin/day
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Biodel
INDUSTRY
Responsible Party
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Locations
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Profil Institute for Clinical Research
Chula Vista, California, United States
Countries
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Other Identifiers
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3-152
Identifier Type: -
Identifier Source: org_study_id
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