This trial is active, not recruiting.

Condition diabetes mellitus
Treatments biod-531, humalog® mix 75/25
Phase phase 2
Sponsor Biodel
Start date May 2015
End date June 2016
Trial size 130 participants
Trial identifier NCT02446028, 3-250


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
BIOD-531 injected twice daily
(Active Comparator)
Humalog® Mix 75/25 injected twice daily
humalog® mix 75/25

Primary Outcomes

Change in HbA1c
time frame: 18 weeks

Secondary Outcomes

Postprandial glucose excursions
time frame: 18 weeks
Change in weight
time frame: 18 weeks
Hypoglycemic event rates
time frame: 18 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

Official title A Randomized, Open-label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes
Description BIOD-531 is a formulation of recombinant human insulin with a biphasic absorption profile characterized by rapid absorption (to prevent meal-time rises in blood glucose) and a secondary longer (basal) phase. The purpose of this trial is to evaluate glucose control and safety of BIOD-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Biodel.