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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01686620
First received: September 13, 2012
Last updated: March 28, 2013
Last verified: March 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686620

  Show 34 Study Locations
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, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014