Clinical trial NCT02446028: A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 18 weeks
Secondary outcomes:
measure: Postprandial glucose excursions
timeFrame: 18 weeks
measure: Change in weight
timeFrame: 18 weeks
measure: Hypoglycemic event rates
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Springfield
country: United States
facility: Springfield Diabetes and Endocrine Center
state: Illinois
city: Morehead City
country: United States
facility: Diabetes and Endocrinology Consultants
state: North Carolina
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Renton
country: United States
facility: Ranier Clinical Research Center
state: Washington
Study officials:
References: