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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
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
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
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.
Time frame: 24 Weeks
Percentage of Patients Achieving HbA1c <=7% at Week 24
This is a component of the primary endpoint
Time frame: 24 Weeks
Percentage of Patients With no Weight Gain at Week 24
This is a component of the primary endpoint
Time frame: 24 Weeks
Percentage of Patients With a Severe Hypoglycemia Adverse Event
This is a component of the primary endpoint.
Time frame: 24 Weeks
Change in HbA1c From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Change in Body Weight From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Change in Waist Circumference From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Change in Fasting Plasma Glucose From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Fasting Serum Lipids Change From Baseline to Week 24
Time frame: Baseline, week 24
Phase 2: Change in HbA1c at 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).
Time frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Phase 2: Change in Body Weight at 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).
Time frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
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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
...and 27 more locations