Pharmacokinetic and Injection Site Toleration of BIOD-238... | NCT01811849

Studies
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

NCT01811849

Sponsor

Biodel

Status

Completed

Last Update Posted

Mar 15, 2013Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Type 1 Diabetes

Interventions

Insulin LISPRO
Insulin LISPRO
Insulin LISPRO

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 13, 2013

First Submission Date that Met QC Criteria

Mar 14, 2013

First Posted Date

Mar 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2013

Last Update Posted Date

Mar 15, 2013Estimated

Description Module

Brief Summary

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Detailed Description

The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIOD-238	Experimental	Subcutaneous injection	Drug: Insulin LISPRO
BIOD-250	Experimental	Subcutaneous injection	Drug: Insulin LISPRO
Humalog	Active Comparator	Subcutaneous injection	Drug: Insulin LISPRO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin LISPRO	Drug		BIOD-238
Insulin LISPRO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to 1/2 maximal insulin concentration		480 minutes

Secondary Outcomes

Measure	Description	Time Frame
Time to maximal insulin concentration		480 minutes
Time to 1/2 maximal insulin concentration after peak		480 minutes
Visual analog scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: ≥18 to ≤70 years
Body Mass Index: ≥18 and ≤35 kg/m2
Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion Criteria:

Type 2 diabetes mellitus
Serum C-peptide >1.0 ng/mL
HbA1c >10.0%
History of hypersensitivity to any of the components in the study medication
Treatment with any other investigational drug in the last 30 days before dosing.
Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061268	Insulin Lispro

Ancestor Terms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided