A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

Paused · Phase 2

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02446028

Run by

Biodel

People needed

13

Starts

2015-05-01

Expected to finish

2016-05-01

Last updated by the study team

2016-04-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established clinical diagnosis of type 2 diabetes, consistent with ADA classification criteria for 6 months or longer.
• Body Mass Index 27 - 45 kg/square meter, inclusive.
• Screening HbA1c between 7.5 and 11.0%, inclusive.
• Up to two injections per day of U-100 basal (NPH, glargine, or detemir), pre-mixed, or self-mixed basal/prandial insulins or insulin analogs at stable total daily doses between 40 -200 units/day, inclusive, for ≥ 3 months prior to screening.

You may not qualify if…

• Regular use of Humulin®R U-500 or sulfonylurea, exenatide (short-acting), repaglinide, or nateglinide within 1 month prior to screening.
• History of bariatric surgery.
• Subject has had one or more severe hypoglycemic episodes associated with seizure, coma, or unconsciousness within the past 6 months.
• History of known hypersensitivity to any of the components in the study medication.
• New York Heart Association (NYHA) Class III or IV functional capacity, unstable angina pectoris, myocardial infarction, severe peripheral vascular disease, ischemic strokes or transient ischemic attacks within 6 months of screening.
• Systolic blood pressure ≥ 180 mmHg or sitting diastolic blood pressure ≥ 100 mmHg confirmed on repeat during screening visit.

Where it is running

• Meridien Research — Bradenton, Florida, United States
• Endocrine Research Solutions — Roswell, Georgia, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• Springfield Diabetes and Endocrine Center — Springfield, Illinois, United States
• Diabetes and Endocrinology Consultants — Morehead City, North Carolina, United States
• Clinical Trials of Texas — San Antonio, Texas, United States
• Ranier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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