Type 2 Diabetes MellitusPhase 4NCT00240253
A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
A Phase 4 study testing pramlintide acetate in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 34 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- 200 participants
- Where
- 34 sitesUnited States
- Study dates
- Oct 2005to Jun 2006
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has HbA1c >7.0% and <=10.5%
- Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2
- Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
- If taking oral antidiabetic agents, has been on a stable dose for at least 2 months
Who cannot join
- Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
- Has received any investigational drug within 1 month of screening
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Research Site
Atlanta, Georgia
Research Site
Baton Rouge, Louisiana
Research Site
Bloomfield Hills, Michigan
Research Site
Butte, Montana
Research Site
Charlotte, North Carolina
Research Site
Charlottesville, Virginia
Research Site
Chesterfield, Missouri
Research Site
Cincinnati, Ohio
Research Site
Concord, California
Research Site
Dallas, Texas
Research Site
Denver, Colorado
Research Site
Detroit, Michigan
Research Site
Durham, North Carolina
Research Site
Grand Rapids, Michigan
Research Site
Indianapolis, Indiana
Research Site
La Jolla, California
Research Site
Lexington, Kentucky
Research Site
Los Gatos, California
Research Site
Medford, Oregon
Research Site
Nashville, Tennessee
Research Site
New Britain, Connecticut
Research Site
Oklahoma City, Oklahoma
Research Site
Olympia, Washington
Research Site
Omaha, Nebraska
Research Site
Palm Harbor, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Portland, Oregon
Research Site
Salinas, California
Research Site
Spokane, Washington
Research Site
Tipton, Pennsylvania
Research Site
Walnut Creek, California
Research Site
Washington D.C., District of Columbia
Research Site
Wichita, Kansas
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- pramlintide acetate
- Keywords
- diabetes, Amylin, Symlin, pramlintide, insulin glargine
- Medical subject headings
- 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
Clear, colorless, sterile solution for SC injection
| Study group | Role | What they receive |
|---|---|---|
| Pramlintide | Active comparator | Not described Receives: Drug: pramlintide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.
Measured: 16 Weeks
Secondary outcomes (1)
To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2006
- Study completionJun 2006
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 2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (actual)
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
- NCT00240253
- Sponsor's protocol ID
- 137-156
- Status last verified
- Mar 2015
- First submitted
- 14 Oct 2005
- Last updated
- 31 Mar 2015
- Results posted
- No
Publications
Peyrot M, Rubin RR, Polonsky WH. Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy. Diabetes Technol Ther. 2008 Dec;10(6):461-6. doi: 10.1089/dia.2008.0031.
PubMed 19049375Wysham C, Lush C, Zhang B, Maier H, Wilhelm K. Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes. Curr Med Res Opin. 2008 Jan;24(1):79-85. doi: 10.1185/030079908x253537.
PubMed 18031595Riddle M, Frias J, Zhang B, Maier H, Brown C, Lutz K, Kolterman O. Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care. 2007 Nov;30(11):2794-9. doi: 10.2337/dc07-0589. Epub 2007 Aug 13.
PubMed 17698615
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
- ClinicalTrials.gov ID
- NCT00240253
- Acronym / sponsor ID
- 137-156
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, Amylin, Symlin, pramlintide, insulin glargine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 18 Oct 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.
The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pramlintide | Active comparator | Drug: pramlintide acetate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has HbA1c >7.0% and <=10.5%
- Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2
- Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
- If taking oral antidiabetic agents, has been on a stable dose for at least 2 months
Key exclusion criteria (2 listed)
- Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
- Has received any investigational drug within 1 month of 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 |
|---|---|---|
| pramlintide acetateClear, colorless, sterile solution for SC injection | Drug | Pramlintide |
Primary outcome
To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.
Time frame: 16 Weeks
1 secondary outcome
To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes.
Time frame: 16 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 31 Mar 2015.
- Derived from this study: PubMed 19049375Peyrot M, Rubin RR, Polonsky WH. Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy. Diabetes Technol Ther. 2008 Dec;10(6):461-6. doi: 10.1089/dia.2008.0031.
- Derived from this study: PubMed 18031595Wysham C, Lush C, Zhang B, Maier H, Wilhelm K. Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes. Curr Med Res Opin. 2008 Jan;24(1):79-85. doi: 10.1185/030079908x253537.
- Derived from this study: PubMed 17698615Riddle M, Frias J, Zhang B, Maier H, Brown C, Lutz K, Kolterman O. Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care. 2007 Nov;30(11):2794-9. doi: 10.2337/dc07-0589. Epub 2007 Aug 13.
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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.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pramlintide acetate in people with Type 2 Diabetes Mellitus, run by AstraZeneca 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 4 inclusion and 2 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 31 Mar 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes. (time frame: 16 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 NCT00240253, 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 31 Mar 2015.