Type 1 Diabetes MellitusPhase 2NCT01686620
A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
A Phase 2 study testing BIOD-123 and Lispro (Humalog) in people with Type 1 Diabetes Mellitus, run by Biodel at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- BIOD-123 and Lispro (Humalog)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 34 sitesUnited States
- Study dates
- Aug 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Atlanta Diabetes Associates
Atlanta, Georgia, 30309-1764
Texas Diabetes and Endocrinology
Austin, Texas, 78731
Mercury Street Medical
Butte, Montana, 59701
Profil Research Institute
Chula Vista, California, 91911
Sentral Clinical Research Services, LLC
Cincinnati, Ohio, 45236
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Mountain Diabetes & Endrocrine Center
Dallas, Texas, 28803
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, 75006
Research Institute of Dallas
Dallas, Texas, 75231
Baylor Endocrine Center
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48235
Desert Endocrinolgy
Henderson, Nevada, 89052
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
Rocky Mountain Diabetes and Osteoporosis Center PA
Idaho Falls, Idaho, 83404
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
Kentucky Diabetes
Lexington, Kentucky, 40503
Private Practice - Richard Cherlin, MD.
Los Gatos, California, 95032
University of Miami Diabetes Research Institute
Miami, Florida, 33136
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557
Providence Clinical Research Pharmaseek
North Hollywood, California, 91606
Capital Clinical Research Center
Olympia, Washington, 98502
Progressive Medical Research Pharmaseek
Port Orange, Florida, 32127
Oregon Health Sciences University
Portland, Oregon, 97239
Ranier Clinical Research, Inc
Renton, Washington, 98507
Diabetes & Glandular Disease Research
Rockville, Maryland, 20852
Endocrine Research Solutions
Roswell, Georgia, 30076
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681
Sonterra Clinical Research
San Antonio, Texas, 78258
Monteagle Medical Center
San Francisco, California, 94110
Mills-Peninsula Health Services
San Mateo, California, 94401
Rockwood Clinic
Spokane, Washington, 99202
Research Foundation of SUNY Upstate Medical University
Syracuse, New York, 13210
MidAmerica Diabetes Associates, PA
Wichita, Kansas, 67226
About this study
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
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- BIOD-123, Lispro (Humalog)
- Keywords
- Mealtime insulin, Ultra-rapid acting insulin, Prandial insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOD-123Drug
Lispro (Humalog)Drug
| Study group | Role | What they receive |
|---|---|---|
| BIOD-123 | Experimental | BIOD-123 used as prandial insulin Receives: Drug: BIOD-123 |
| Lispro (Humalog) | Active comparator | Lispro (Humalog) used as prandial insulin Receives: Drug: Lispro (Humalog) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C
Measured: Baseline and 18 week treatment period
Secondary outcomes (3)
Hypoglycemic event rates
Measured: Baseline and 18 week treatment period
Insulin dose
Measured: Baseline and 18 week treatment period
Daily blood glucose measures
Measured: Baseline and 18 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686620
- Sponsor's protocol ID
- 3-201
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01686620
- Acronym / sponsor ID
- 3-201
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Mealtime insulin, Ultra-rapid acting insulin, Prandial insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIOD-123 | Experimental | Drug: BIOD-123BIOD-123 used as prandial insulin |
| Lispro (Humalog) | Active comparator | Drug: Lispro (Humalog)Lispro (Humalog) used as prandial insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOD-123 | Drug | BIOD-123 |
| Lispro (Humalog) | Drug | Lispro (Humalog) |
Primary outcome
Change in HbA1C
Time frame: Baseline and 18 week treatment period
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIOD-123 and Lispro (Humalog) in people with Type 1 Diabetes Mellitus, run by Biodel at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1C (time frame: Baseline and 18 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.