Diabetes Mellitus, Type 1Phase 3NCT00042458
Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
A Phase 3 study testing Pramlintide acetate in people with Diabetes Mellitus, Type 1, run by AstraZeneca at 33 sites in United States.
Trial summary
This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Pramlintide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 33 sitesUnited States
- Study dates
- Apr 2002to Mar 2003
- 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
- HbA1c value between 7.5-9%
- Using multiple daily insulin injections
Who cannot join
None listed.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Atlanta Diabetes Associates
Atlanta, Georgia
Medical Research Unlimited
Aventura, Florida, 33180
Medical Research Unlimited
Aventura, Florida
University of Maryland Joslin Diabetes Center
Baltimore, Maryland, 21012
Mercury Street Medical
Butte, Montana
Physicians for Clinical Research
Camp Hill, Pennsylvania
St. James Diabetes Center
Chicago Heights, Illinois, 60411
St. James Diabetes Center
Chicago Heights, Illinois
Ohio State Univ.-Division of Endocrinology, Diabetes
Columbus, Ohio, 43210
East Bay Clinical Trial Center
Concord, California
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262
Henry Ford Health System
Detroit, Michigan
UNC Diabetes Care Center
Durham, North Carolina, 27713
Internal Medicine Associates
Fort Myers, Florida
Valley Research
Fresno, California
Grand Rapids Associated Interns
Grand Rapids, Michigan
Indiana University Outpatient Clinical Research
Indianapolis, Indiana
North Texas Clinical Research
Irving, Texas
Private Practice
Lufkin, Texas, 75904
Private Practice
Lufkin, Texas
Ana Ventures LLC
Mesa, Arizona, 85204
Vanderbilt University Medical Center
Nashville, Tennessee
Suncoast Clinical Research
New Port Richey, Florida
Phoenix Endocrinology Clinic, Ltd.
Phoenix, Arizona, 85006
Radiant Research
Portland, Oregon
Rainier Clinical Research Center
Renton, Washington
UCSD Diabetes Research Center
San Diego, California
Diabetes Research Institute
San Mateo, California
Sansum Medical Research Institute
Santa Barbara, California
Radiant Research
St Louis, Missouri, 63141
Children's Clinic
Tallahassee, Florida
Diablo Clinical Research
Walnut Creek, California
MedStar Clinical Research Center
Washington D.C., District of Columbia
About this study
Official title: A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy
This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Pramlintide acetate, Placebo
- 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.
Pramlintide acetateDrug
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
PlaceboDrug
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL Receives: Drug: Placebo |
| Pramlintide Acetate (AC137) | Active comparator | Pramlintide acetate (AC137) 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. The strength of pramlintide injection is 0.6 mg/mL Receives: Drug: Pramlintide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.
Measured: 29 Weeks
Secondary outcomes (2)
- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
Measured: 29 Weeks
- To examine the pattern of daily insulin use over the course of the study.
Measured: 29 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2002 (estimated)
- Study startApr 2002
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042458
- Sponsor's protocol ID
- 137-150
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2002
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- 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 23748514
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy
- ClinicalTrials.gov ID
- NCT00042458
- Acronym / sponsor ID
- 137-150
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 1 Aug 2002 (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 is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL |
| Pramlintide Acetate (AC137) | Active comparator | Drug: Pramlintide acetatePramlintide acetate (AC137) 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. The strength of pramlintide injection is 0.6 mg/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HbA1c value between 7.5-9%
- Using multiple daily insulin injections
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 injection will be supplied in 5-mL multidose glass vials with rubber stoppers. | Drug | Pramlintide Acetate (AC137) |
| PlaceboThe placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper. | Drug | Placebo |
Primary outcome
- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.
Time frame: 29 Weeks
2 secondary outcomes
- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
Time frame: 29 Weeks
- To examine the pattern of daily insulin use over the course of the study.
Time frame: 29 Weeks
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 23 Sep 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.
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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.
33 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 Diabetes Mellitus, Type 1, run by AstraZeneca at 33 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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. Some participants in this study may receive a placebo. 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 safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes. (time frame: 29 Weeks). 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 NCT00042458, which also lists 1 linked publication.
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 23 Sep 2015.