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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2012
Last Updated Date	March 28, 2013
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 18, 2012)	Change in HbA1C [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: September 13, 2012)	Change in HbA1C [ Time Frame: 18 week treatment period ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT01686620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 18, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 13, 2012)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Type 1 Diabetes Mellitus
Intervention ^ICMJE	Drug: BIOD-123 Drug: Lispro (Humalog)
Study Arm (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	130
Completion Date	Not Provided
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01686620
Other Study ID Numbers ^ICMJE	3-201
Has Data Monitoring Committee	No
Responsible Party	Biodel
Study Sponsor ^ICMJE	Biodel
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biodel
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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