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Completed

NCT Number: NCT01686620

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIOD-123

Drug

Lispro (Humalog)

Drug

Primary outcomes

  1. Change in HbA1C

    Time frame: Baseline and 18 week treatment period

Secondary outcomes

  1. Hypoglycemic event rates

    Time frame: Baseline and 18 week treatment period

  2. Insulin dose

    Time frame: Baseline and 18 week treatment period

  3. Daily blood glucose measures

    Time frame: Baseline and 18 week treatment period

Sponsors and collaborators

Lead sponsor

Biodel

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 18, 2012
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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