Type 1 Diabetes MellitusPhase 3NCT00108004
Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
A Phase 3 study testing pramlintide acetate in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by AstraZeneca at 48 sites in United States.
Trial summary
This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- pramlintide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 48 sitesUnited States
- Study dates
- Apr 2003to Jun 2005
- Phase
- Phase 3
- 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
- The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.
- The subject has a HbA1c of 7.0% to 11.0% at Screening.
Who cannot join
None listed.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Research Site
Anaheim, California
Research Site
Arlington, Texas
Research Site
Baltimore, Maryland
Research Site
Bloomfield Hills, Michigan
Research Site
Charleston, South Carolina
Research Site
Chattanooga, Tennessee
Research Site
Clearwater, Florida
Research Site
Columbus, Georgia
Research Site
Dallas, Texas
Research Site
Escondido, California
Research Site
Greenville, North Carolina
Research Site
Honolulu, Hawaii
Research Site
Idaho Falls, Idaho
Research Site
Indianapolis, Indiana
Research Site
Knoxville, Tennessee
Research Site
La Jolla, California
Research Site
Lakewood, Ohio
Research Site
Las Vegas, Nevada
Research Site
Lexington, Kentucky
Research Site
Los Gatos, California
Research Site
Madison, Wisconsin
Research Site
Memphis, Tennessee
Research Site
Milwaukee, Wisconsin
Research Site
Moorestown, New Jersey
Research Site
Nashville, Tennessee
Research Site
Neptune City, New Jersey
Research Site
New Britain, Connecticut
Research Site
New York, New York
Research Site
Norwalk, Connecticut
Research Site
Norwich, Connecticut
Research Site
Olympia, Washington
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Portland, Oregon
Research Site
Reno, Nevada
Research Site
Roseland, New Jersey
Research Site
San Francisco, California
Research Site
Sumter, South Carolina
Research Site
Topeka, Kansas
Research Site
Torrance, California
Research Site
Tupelo, Mississippi
Research Site
Vincennes, Indiana
Research Site
Washington D.C., District of Columbia
Research Site
Westlake, Ohio
Research Site
Wichita, Kansas
Research Site
Wilkes-Barre, Pennsylvania
Research Site
Williston Park, New York
Research Site
Yonkers, New York
About this study
Official title: A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy
This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- pramlintide acetate
- Keywords
- Diabetes, Amylin, Symlin, pramlintide acetate
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pramlintide acetateDrug
Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.
| Study group | Role | What they receive |
|---|---|---|
| Pramlintide | Experimental | Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection.
It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43-mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative Receives: Drug: pramlintide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.
Measured: 6 months
Understand management issues in subjects with type 1 and type 2 diabetes mellitus
To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2005 (estimated)
- Study startApr 2003
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Porter, MD, Study director, Amylin Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108004
- Sponsor's protocol ID
- 137-155
- Status last verified
- May 2015
- First submitted
- 12 Apr 2005
- Last updated
- 21 May 2015
- Results posted
- No
Publications
Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG. Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. Postgrad Med. 2013 May;125(3):136-44. doi: 10.3810/pgm.2013.05.2635.
PubMed 23748514Karl D, Philis-Tsimikas A, Darsow T, Lorenzi G, Kellmeyer T, Lutz K, Wang Y, Frias JP. Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight. Diabetes Technol Ther. 2007 Apr;9(2):191-9. doi: 10.1089/dia.2006.0013.
PubMed 17425446Edelman SV, Darsow T, Frias JP. Pramlintide in the treatment of diabetes. Int J Clin Pract. 2006 Dec;60(12):1647-53. doi: 10.1111/j.1742-1241.2006.01187.x.
PubMed 17109671
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy
- ClinicalTrials.gov ID
- NCT00108004
- Acronym / sponsor ID
- 137-155
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Amylin, Symlin, pramlintide acetate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 13 Apr 2005 (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.
This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pramlintide | Experimental | Drug: pramlintide acetatePramlintide acetate injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43-mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.
- The subject has a HbA1c of 7.0% to 11.0% at Screening.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| pramlintide acetatePramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial. | Drug | Pramlintide |
Primary outcome
To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
Time frame: 6 months
To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.
Understand management issues in subjects with type 1 and type 2 diabetes mellitus
Time frame: 6 months
To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy
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 21 May 2015.
- Derived from this study: PubMed 23748514Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG. Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. Postgrad Med. 2013 May;125(3):136-44. doi: 10.3810/pgm.2013.05.2635.
- Derived from this study: PubMed 17425446Karl D, Philis-Tsimikas A, Darsow T, Lorenzi G, Kellmeyer T, Lutz K, Wang Y, Frias JP. Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight. Diabetes Technol Ther. 2007 Apr;9(2):191-9. doi: 10.1089/dia.2006.0013.
- Derived from this study: PubMed 17109671Edelman SV, Darsow T, Frias JP. Pramlintide in the treatment of diabetes. Int J Clin Pract. 2006 Dec;60(12):1647-53. doi: 10.1111/j.1742-1241.2006.01187.x.
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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.
Lisa Porter, MD study director
Amylin Pharmaceuticals, LLC.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pramlintide acetate in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by AstraZeneca at 48 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 2 inclusion and 0 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00108004, which also lists 3 linked publications.
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 21 May 2015.