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

September 13, 2012
March 28, 2013
August 2012
September 2013   (final data collection date for primary outcome measure)
Change in HbA1C [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: Yes ]
Change in HbA1C [ Time Frame: 18 week treatment period ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01686620 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hypoglycemic event rates [ Time Frame: 18 week treatment period ] [ Designated as safety issue: Yes ]
  • Insulin dose [ Time Frame: 18 week treatment period ] [ Designated as safety issue: No ]
  • Daily blood glucose measures [ Time Frame: 18 week treatment period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: BIOD-123
  • Drug: Lispro (Humalog)
  • Experimental: BIOD-123
    BIOD-123 used as prandial insulin
    Intervention: Drug: BIOD-123
  • Active Comparator: Lispro (Humalog)
    Lispro (Humalog) used as prandial insulin
    Intervention: Drug: Lispro (Humalog)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01686620
3-201
No
Biodel
Biodel
Not Provided
Not Provided
Biodel
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP