Status:
UNKNOWN
Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
Lead Sponsor:
Cheryl Rosenfeld, DO
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily with expected gluco...
Eligibility Criteria
Inclusion
- Age 18-80 years.
- Type 2 diabetes mellitus.
- Obese (BMI \> 30 kg/m2), waist circ. \>35" women, \>40" men.
- Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin.
- On stable insulin dose for at least 3 mos (baseline + 20%, no minimum).
- If pramlintide treated, on stable full dose for at least 3 months.
- A1c \> 7.0% and \< 9.0%.
- Women of childbearing age if using a reliable form of birth control.
- Women of childbearing age if post tubal ligation or surgical menopause.
- Able to consent.
- Willing to perform self-monitoring of glucose.
- Willing to attend study visits.
- Written informed consent to participate in the study.
- Agreement to maintain prior diet and exercise throughout the full course of the study.
Exclusion
- Age \<18 or \>80 years.
- Confirmed gastroparesis or taking medications affecting gastric motility.
- A1c \<7.0% or \>9.0%.
- Recurrent severe hypoglycemia or hypoglycemic unawareness.
- CHF.
- Creatinine clearance \<30 ml/min.
- History of MI \<6 mos prior to enrollment.
- History of ventricular arrhythmia.
- History of cancer or chemotherapy \<6 mos prior to enrollment.
- Laboratory abnormalities as follows:
- Liver enzymes \>3X ULN.
- Hematocrit less than 30.
- Serum creatinine \>2.5 mg/dl.
- Fasting triglycerides \>500 mg/dl.
- Cirrhosis.
- Pregnancy or nursing.
- Inability to provide consent.
- Unwilling to attend study visits.
- Unwilling to perform self-monitoring of glucose.
- Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening.
- Investigational drug treatment within 3 months prior to screening.
- Donation of blood, significant blood loss or transfusion within 3 months of screening.
- History of acromegaly or Cushing's syndrome.
- Use of prohibited concomitant medications.
- Type 1 diabetes mellitus.
- Acute metabolic complication (hyperosmolar state) \<6 months prior to screening.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01137695
Start Date
May 1 2010
End Date
April 1 2012
Last Update
October 14 2011
Active Locations (3)
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1
North Jersey Endocrine Consultants
Denville, New Jersey, United States, 07834
2
University Physicians Group
Staten Island, New York, United States, 10301
3
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047