Status:
COMPLETED
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00467649
Start Date
May 1 2007
End Date
April 1 2008
Last Update
April 14 2015
Active Locations (37)
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1
Research Site
Northport, Alabama, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Loma Linda, California, United States
4
Research Site
Aurora, Colorado, United States