NCT02446028

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
13

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2 diabetes-mellitus

Geographic Reach
1 country

7 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

May 13, 2015

Last Update Submit

March 9, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    18 weeks

Secondary Outcomes (3)

  • Postprandial glucose excursions

    18 weeks

  • Change in weight

    18 weeks

  • Hypoglycemic event rates

    18 weeks

Study Arms (2)

BIOD-531

EXPERIMENTAL

BIOD-531 injected twice daily

Drug: BIOD-531

Humalog® Mix 75/25

ACTIVE COMPARATOR

Humalog® Mix 75/25 injected twice daily

Drug: Humalog® Mix 75/25

Interventions

BIOD-531DRUG
BIOD-531
Humalog® Mix 75/25DRUG
Humalog® Mix 75/25

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Meridien Research

Bradenton, Florida, 34208, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Springfield Diabetes and Endocrine Center

Springfield, Illinois, 62711, United States

Location

Diabetes and Endocrinology Consultants

Morehead City, North Carolina, 28557, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Ranier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 15, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-03

Locations

US(7)