DRUG
pramlintide acetate (Symlin)
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
Status
Completed
Phase
Phase 4
Enrollment
112
Locations
37
Results
Posted
Publications
1
Study 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.
Interventions
DRUG
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
DRUG
subcutaneous injection, dosing based on titration guidelines
DRUG
subcutaneous injection, dosing based on titration guidelines
Timeline
First posted
May 1, 2007
Study start
May 2007
Primary completion
Apr 2008
Study completion
Apr 2008
Results posted
Jun 4, 2009
Registry updated
Apr 14, 2015
Outcomes
The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
Time frame · 24 Weeks
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.
Percentage of Patients Achieving HbA1c <=7% at Week 24
Time frame · 24 Weeks
This is a component of the primary endpoint
Percentage of Patients With no Weight Gain at Week 24
Time frame · 24 Weeks
This is a component of the primary endpoint
Percentage of Patients With a Severe Hypoglycemia Adverse Event
Time frame · 24 Weeks
This is a component of the primary endpoint.
Change in HbA1c From Baseline at Week 24
Time frame · From Baseline to Week 24
Baseline values are presented in the Baseline Characteristics section
Change in Body Weight From Baseline at Week 24
Time frame · From Baseline to Week 24
Baseline values are presented in the Baseline Characteristics section
Change in Waist Circumference From Baseline at Week 24
Time frame · From Baseline to Week 24
Baseline values are presented in the Baseline Characteristics section
Change in Fasting Plasma Glucose From Baseline at Week 24
Time frame · From Baseline to Week 24
Baseline values are presented in the Baseline Characteristics section
Fasting Serum Lipids Change From Baseline to Week 24
Time frame · Baseline, week 24
Phase 2: Change in HbA1c at Week 36
Time frame · Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
Phase 2: Change in Body Weight at Week 36
Time frame · Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
Eligibility
Inclusion Criteria: * 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 Criteria: * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
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