Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500

Completed · Phase 1/Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02212951

Run by

Biodel

People needed

12

Starts

2014-05-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65
• BMI > 25 kg/m2
• Type 2 Diabetes Mellitus
• HbA1c < 10.0%
• Subject uses 50-200 units of insulin/day

You may not qualify if…

• 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

Where it is running

• Profil Institute for Clinical Research — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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