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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02446028
• Other study ID #: 3-250
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 13, 2015
• Last updated: July 30, 2015
• Start date: May 2015

Study information

• Verified date: July 2015
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• BIOD-531

• Humalog® Mix 75/25

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		18 weeks	No
Secondary	Postprandial glucose excursions		18 weeks	No
Secondary	Change in weight		18 weeks	No
Secondary	Hypoglycemic event rates		18 weeks	Yes