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A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BIOD-123
Lispro (Humalog)
Sponsored by
Biodel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Mealtime insulin, Ultra-rapid acting insulin, Prandial insulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.
  • Age: 18 years old, or older.
  • Body Mass Index: between 18 and 35 kg/m2, inclusive.
  • Willing to use insulin glargine as the only basal insulin throughout the duration of the trial.
  • Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.

Exclusion Criteria:

  • History of known hypersensitivity to any of the components in the study medication
  • Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study.
  • Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed.
  • Consistent recent hypoglycemic unawareness within the last six months
  • History of more than two severe hypoglycemic events within six months prior to screening

Sites / Locations

  • Anaheim Clinical Trials, LLC
  • Profil Research Institute
  • John Muir Physician Network Clinical Research Center
  • Scripps Whittier Diabetes Institute
  • Private Practice - Richard Cherlin, MD.
  • Providence Clinical Research Pharmaseek
  • Monteagle Medical Center
  • Mills-Peninsula Health Services
  • The Center for Diabetes and Endocrine Care
  • University of Miami Diabetes Research Institute
  • Progressive Medical Research Pharmaseek
  • Atlanta Diabetes Associates
  • Endocrine Research Solutions
  • Rocky Mountain Diabetes and Osteoporosis Center PA
  • MidAmerica Diabetes Associates, PA
  • Kentucky Diabetes
  • Diabetes & Glandular Disease Research
  • Henry Ford Health System
  • Mercury Street Medical
  • Desert Endocrinolgy
  • Research Foundation of SUNY Upstate Medical University
  • Diabetes & Endocrinology Consultants, PC
  • Sentral Clinical Research Services, LLC
  • Oregon Health Sciences University
  • Texas Diabetes and Endocrinology
  • Mountain Diabetes & Endrocrine Center
  • Dallas Diabetes and Endocrine Research Center
  • Research Institute of Dallas
  • Baylor Endocrine Center
  • Texas Diabetes and Endocrinology
  • Sonterra Clinical Research
  • Capital Clinical Research Center
  • Ranier Clinical Research, Inc
  • Rockwood Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIOD-123

Lispro (Humalog)

Arm Description

BIOD-123 used as prandial insulin

Lispro (Humalog) used as prandial insulin

Outcomes

Primary Outcome Measures

Change in HbA1C

Secondary Outcome Measures

Hypoglycemic event rates
Insulin dose
Daily blood glucose measures

Full Information

First Posted
September 13, 2012
Last Updated
July 22, 2015
Sponsor
Biodel
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1. Study Identification

Unique Protocol Identification Number
NCT01686620
Brief Title
A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
Official Title
A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes Using Basal-bolus Insulin Injection Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biodel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Mealtime insulin, Ultra-rapid acting insulin, Prandial insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIOD-123
Arm Type
Experimental
Arm Description
BIOD-123 used as prandial insulin
Arm Title
Lispro (Humalog)
Arm Type
Active Comparator
Arm Description
Lispro (Humalog) used as prandial insulin
Intervention Type
Drug
Intervention Name(s)
BIOD-123
Intervention Type
Drug
Intervention Name(s)
Lispro (Humalog)
Primary Outcome Measure Information:
Title
Change in HbA1C
Time Frame
Baseline and 18 week treatment period
Secondary Outcome Measure Information:
Title
Hypoglycemic event rates
Time Frame
Baseline and 18 week treatment period
Title
Insulin dose
Time Frame
Baseline and 18 week treatment period
Title
Daily blood glucose measures
Time Frame
Baseline and 18 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year. Age: 18 years old, or older. Body Mass Index: between 18 and 35 kg/m2, inclusive. Willing to use insulin glargine as the only basal insulin throughout the duration of the trial. Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial. Exclusion Criteria: History of known hypersensitivity to any of the components in the study medication Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study. Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed. Consistent recent hypoglycemic unawareness within the last six months History of more than two severe hypoglycemic events within six months prior to screening
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Profil Research Institute
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
John Muir Physician Network Clinical Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Scripps Whittier Diabetes Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Private Practice - Richard Cherlin, MD.
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Providence Clinical Research Pharmaseek
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Monteagle Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Mills-Peninsula Health Services
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
The Center for Diabetes and Endocrine Care
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Miami Diabetes Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Progressive Medical Research Pharmaseek
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309-1764
Country
United States
Facility Name
Endocrine Research Solutions
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center PA
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
MidAmerica Diabetes Associates, PA
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Kentucky Diabetes
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Diabetes & Glandular Disease Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Desert Endocrinolgy
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Research Foundation of SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Diabetes & Endocrinology Consultants, PC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Sentral Clinical Research Services, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Mountain Diabetes & Endrocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
28803
Country
United States
Facility Name
Dallas Diabetes and Endocrine Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Sonterra Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Capital Clinical Research Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Ranier Clinical Research, Inc
City
Renton
State/Province
Washington
ZIP/Postal Code
98507
Country
United States
Facility Name
Rockwood Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

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A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

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