A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00240253 |
Recruitment Status :
Completed
First Posted : October 18, 2005
Last Update Posted : March 31, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: pramlintide acetate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Pramlintide |
Drug: pramlintide acetate
Clear, colorless, sterile solution for SC injection |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240253
United States, Arizona | |
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Phoenix, Arizona, United States | |
United States, California | |
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Concord, California, United States | |
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La Jolla, California, United States | |
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Los Gatos, California, United States | |
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Salinas, California, United States | |
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Walnut Creek, California, United States | |
United States, Colorado | |
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Denver, Colorado, United States | |
United States, Connecticut | |
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New Britain, Connecticut, United States | |
United States, District of Columbia | |
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Washington, District of Columbia, United States | |
United States, Florida | |
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Palm Harbor, Florida, United States | |
United States, Georgia | |
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Atlanta, Georgia, United States | |
United States, Indiana | |
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Indianapolis, Indiana, United States | |
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Wichita, Kansas, United States | |
United States, Kentucky | |
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Lexington, Kentucky, United States | |
United States, Louisiana | |
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Baton Rouge, Louisiana, United States | |
United States, Michigan | |
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Bloomfield Hills, Michigan, United States | |
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Detroit, Michigan, United States | |
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Grand Rapids, Michigan, United States | |
United States, Missouri | |
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Chesterfield, Missouri, United States | |
United States, Montana | |
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Butte, Montana, United States | |
United States, Nebraska | |
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Omaha, Nebraska, United States | |
United States, North Carolina | |
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Charlotte, North Carolina, United States | |
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Durham, North Carolina, United States | |
United States, Ohio | |
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Cincinnati, Ohio, United States | |
United States, Oklahoma | |
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Oklahoma City, Oklahoma, United States | |
United States, Oregon | |
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Medford, Oregon, United States | |
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Portland, Oregon, United States | |
United States, Pennsylvania | |
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Philadelphia, Pennsylvania, United States | |
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Tipton, Pennsylvania, United States | |
United States, Tennessee | |
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Nashville, Tennessee, United States | |
United States, Texas | |
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Dallas, Texas, United States | |
United States, Virginia | |
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Charlottesville, Virginia, United States | |
United States, Washington | |
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Olympia, Washington, United States | |
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Spokane, Washington, United States |
Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00240253 |
Other Study ID Numbers: |
137-156 |
First Posted: | October 18, 2005 Key Record Dates |
Last Update Posted: | March 31, 2015 |
Last Verified: | March 2015 |
diabetes Amylin Symlin pramlintide insulin glargine |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pramlintide Hypoglycemic Agents Physiological Effects of Drugs |