This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Biodel Identifier:
First received: September 13, 2012
Last updated: July 22, 2015
Last verified: July 2015
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Hypoglycemic event rates [ Time Frame: Baseline and 18 week treatment period ]
  • Insulin dose [ Time Frame: Baseline and 18 week treatment period ]
  • Daily blood glucose measures [ Time Frame: Baseline and 18 week treatment period ]

Enrollment: 132
Study Start Date: August 2012
Study Completion Date: June 2013
Primary Completion Date: June 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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01686620

  Show 34 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Biodel Identifier: NCT01686620     History of Changes
Other Study ID Numbers: 3-201
Study First Received: September 13, 2012
Last Updated: July 22, 2015

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 Lispro
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 20, 2017