A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
This study is ongoing, but not recruiting participants.
Sponsor:
Biodel
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01686620
First received: September 13, 2012
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: BIOD-123 Drug: Lispro (Humalog) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Biodel:
Primary Outcome Measures:
- Change in HbA1C [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Hypoglycemic event rates [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: Yes ]
- Insulin dose [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: No ]
- Daily blood glucose measures [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIOD-123
BIOD-123 used as prandial insulin
|
Drug: BIOD-123 |
|
Active Comparator: Lispro (Humalog)
Lispro (Humalog) used as prandial insulin
|
Drug: Lispro (Humalog) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686620
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Hide Study LocationsLocations
| United States, California | |
| Anaheim Clinical Trials, LLC | |
| Anaheim, California, United States, 92801 | |
| Profil Research Institute | |
| Chula Vista, California, United States, 91911 | |
| John Muir Physician Network Clinical Research Center | |
| Concord, California, United States, 94520 | |
| Scripps Whittier Diabetes Institute | |
| La Jolla, California, United States, 92037 | |
| Private Practice - Richard Cherlin, MD. | |
| Los Gatos, California, United States, 95032 | |
| Providence Clinical Research Pharmaseek | |
| North Hollywood, California, United States, 91606 | |
| Monteagle Medical Center | |
| San Francisco, California, United States, 94110 | |
| Mills-Peninsula Health Services | |
| San Mateo, California, United States, 94401 | |
| United States, Florida | |
| The Center for Diabetes and Endocrine Care | |
| Hollywood, Florida, United States, 33021 | |
| University of Miami Diabetes Research Institute | |
| Miami, Florida, United States, 33136 | |
| Progressive Medical Research Pharmaseek | |
| Port Orange, Florida, United States, 32127 | |
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States, 30309-1764 | |
| Endocrine Research Solutions | |
| Roswell, Georgia, United States, 30076 | |
| United States, Idaho | |
| Rocky Mountain Diabetes and Osteoporosis Center PA | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Kansas | |
| MidAmerica Diabetes Associates, PA | |
| Wichita, Kansas, United States, 67226 | |
| United States, Kentucky | |
| Kentucky Diabetes | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Maryland | |
| Diabetes & Glandular Disease Research | |
| Rockville, Maryland, United States, 20852 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48235 | |
| United States, Montana | |
| Mercury Street Medical | |
| Butte, Montana, United States, 59701 | |
| United States, Nevada | |
| Desert Endocrinolgy | |
| Henderson, Nevada, United States, 89052 | |
| United States, New York | |
| Research Foundation of SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Diabetes & Endocrinology Consultants, PC | |
| Morehead City, North Carolina, United States, 28557 | |
| United States, Ohio | |
| Sentral Clinical Research Services, LLC | |
| Cincinnati, Ohio, United States, 45236 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| Texas Diabetes and Endocrinology | |
| Austin, Texas, United States, 78731 | |
| Research Institute of Dallas | |
| Dallas, Texas, United States, 75231 | |
| Dallas Diabetes and Endocrine Research Center | |
| Dallas, Texas, United States, 75006 | |
| Baylor Endocrine Center | |
| Dallas, Texas, United States, 75246 | |
| Mountain Diabetes & Endrocrine Center | |
| Dallas, Texas, United States, 28803 | |
| Texas Diabetes and Endocrinology | |
| Round Rock, Texas, United States, 78681 | |
| Sonterra Clinical Research | |
| San Antonio, Texas, United States, 78258 | |
| United States, Washington | |
| Capital Clinical Research Center | |
| Olympia, Washington, United States, 98502 | |
| Ranier Clinical Research, Inc | |
| Renton, Washington, United States, 98507 | |
| Rockwood Clinic | |
| Spokane, Washington, United States, 99202 | |
Sponsors and Collaborators
Biodel
More Information
No publications provided
| Responsible Party: | Biodel |
| ClinicalTrials.gov Identifier: | NCT01686620 History of Changes |
| Other Study ID Numbers: | 3-201 |
| Study First Received: | September 13, 2012 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biodel:
|
Mealtime insulin Ultra-rapid acting insulin Prandial insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin LISPRO Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013