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

Phase 2

Suspended

• Conditions: Diabetes Mellitus
• Interventions: Drug: Humalog® Mix 75/25; Drug: BIOD-531

• Registration Number: NCT02446028
• Lead Sponsor: Biodel

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-15
• Disposition First Submitted: 2016-01-15
• Primary Completion: 2016-02
• Status Verified: 2016-03
• Disposition First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Disposition First Posted: 2016-04-07
• Last Update Posted: 2016-04-07
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Humalog® Mix 75/25	Humalog® Mix 75/25	Humalog® Mix 75/25 injected twice daily
BIOD-531	BIOD-531	BIOD-531 injected twice daily

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	18 weeks

Secondary Outcome Measures

Name	Time	Method
Change in weight	18 weeks
Hypoglycemic event rates	18 weeks
Postprandial glucose excursions	18 weeks

Trial Locations

Locations (7)

Ranier Clinical Research Center; 🇺🇸 Renton, Washington, United States

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States

Springfield Diabetes and Endocrine Center; 🇺🇸 Springfield, Illinois, United States

Meridien Research; 🇺🇸 Bradenton, Florida, United States

Endocrine Research Solutions; 🇺🇸 Roswell, Georgia, United States

Cedar Crosse Research Center; 🇺🇸 Chicago, Illinois, United States

Diabetes and Endocrinology Consultants; 🇺🇸 Morehead City, North Carolina, United States