A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
NCT ID: NCT00467649
Last Updated: 2015-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
112 participants
INTERVENTIONAL
2007-05-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
pramlintide acetate (Symlin)
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines
Group B
rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
subcutaneous injection, dosing based on titration guidelines
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines
Interventions
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pramlintide acetate (Symlin)
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
subcutaneous injection, dosing based on titration guidelines
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has an HbA1c \>7.0% and ≤10.0%
* Has a BMI of ≥25 kg/m\^2 and ≤50 kg/m\^2
* Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy
Exclusion Criteria
* Requires the use of drugs that stimulate gastrointestinal motility
* Has been previously treated with Symlin (or has participated in a Symlin clinical study)
* Is currently being treated with any of the following medications: \*Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat \[Xenical®\] and sibutramine \[Meridia®\]); \*Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; \*Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide \[Reglan®\]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; \*Investigational medications
* Has a history or presence of any of the following: \*Eating disorders (including anorexia and/or bulimia); \*Bariatric surgery (gastric bypass, gastric banding, or gastroplasty)
* Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study
* Has donated blood within 30 days of study start or plans to donate blood during the duration of the study
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Northport, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Loma Linda, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Hollywood, Florida, United States
Research Site
Maitland, Florida, United States
Research Site
Miami, Florida, United States
Research Site
North Miami Beach, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Roswell, Georgia, United States
Research Site
Peoria, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Wichita, Kansas, United States
Research Site
Lexington, Kentucky, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Jackson, Mississippi, United States
Research Site
St Louis, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Hamilton, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Albany, New York, United States
Research Site
Staten Island, New York, United States
Research Site
Mentor, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Bridgeville, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Aiken, South Carolina, United States
Research Site
Bartlett, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Olympia, Washington, United States
Research Site
Spokane, Washington, United States
Countries
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References
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Peyrot M, Rubin RR, Polonsky WH, Best JH. Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs. Curr Med Res Opin. 2010 May;26(5):1047-54. doi: 10.1185/03007991003634759.
Other Identifiers
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ACA401
Identifier Type: -
Identifier Source: org_study_id
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