A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
1 other identifier
interventional
112
1 country
37
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes-mellitus
Started May 2007
Shorter than P25 for phase_4 type-2-diabetes-mellitus
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2007
CompletedFirst Posted
Study publicly available on registry
May 1, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
June 4, 2009
CompletedApril 14, 2015
March 1, 2015
11 months
April 27, 2007
April 10, 2009
March 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.
24 Weeks
Secondary Outcomes (10)
Percentage of Patients Achieving HbA1c <=7% at Week 24
24 Weeks
Percentage of Patients With no Weight Gain at Week 24
24 Weeks
Percentage of Patients With a Severe Hypoglycemia Adverse Event
24 Weeks
Change in HbA1c From Baseline at Week 24
From Baseline to Week 24
Change in Body Weight From Baseline at Week 24
From Baseline to Week 24
- +5 more secondary outcomes
Other Outcomes (1)
Hypoglycemia Adverse Events
36 weeks
Study Arms (2)
Group A
EXPERIMENTALGroup B
ACTIVE COMPARATORInterventions
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
subcutaneous injection, dosing based on titration guidelines
subcutaneous injection, dosing based on titration guidelines
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
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
Related Publications (1)
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.
PMID: 20199136DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2007
First Posted
May 1, 2007
Study Start
May 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 14, 2015
Results First Posted
June 4, 2009
Record last verified: 2015-03