BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

Completed · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus

In brief

The study is designed 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 in patients with diabetes and severe insulin resistance.

Key facts

Study ID

NCT02324309

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…

• BMI > 25 kg/m2
• Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
• HbA1c < 10.0%

You may not qualify if…

• 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, Inc. (PICR) — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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