A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

Completed · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.

Key facts

Study ID: NCT00467649
Run by: AstraZeneca
People needed: 112
Starts: 2007-05-01
Expected to finish: 2008-04-01
Last updated by the study team: 2015-04-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has a clinical diagnosis of type 2 diabetes mellitus
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

You may not qualify if…

Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months
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

Where it is running

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

Full record on ClinicalTrials.gov

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