Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
NCT ID: NCT01137695
Last Updated: 2011-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2010-05-31
2012-04-30
Brief Summary
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The primary objective of the study is to determine whether higher doses of pramlintide (Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA approved dose of 120 mcg three times daily.
The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more efficacious in causing weight loss and reduction in waist circumference than standard dose pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with need for higher dose therapy,and to determine whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times daily.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Symlin Naive, Usual Dose
Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.
Pramlintide
120 mcg SQ three times daily for 6 months.
Symlin Naive, Dose Escalation
Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.
Pramlintide
360 mcg SQ three times daily for 6 months
Symlin treated, Usual Dose
pramlintide 120 mcg three times daily in patients who have been treated with pramlintide 120 mcg prior to the trial.
Pramlintide
120 mcg SQ three times daily for 6 months
Symlin Treated, Dose Escalation
pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.
Pramlintide
360 mcg SQ three times daily for 6 months
Interventions
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Pramlintide
120 mcg SQ three times daily for 6 months.
Pramlintide
360 mcg SQ three times daily for 6 months
Pramlintide
120 mcg SQ three times daily for 6 months
Pramlintide
360 mcg SQ three times daily for 6 months
Eligibility Criteria
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Inclusion Criteria
2. Type 2 diabetes mellitus.
3. Obese (BMI \> 30 kg/m2), waist circ. \>35" women, \>40" men.
4. Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin.
5. On stable insulin dose for at least 3 mos (baseline + 20%, no minimum).
6. If pramlintide treated, on stable full dose for at least 3 months.
7. A1c \> 7.0% and \< 9.0%.
8. Women of childbearing age if using a reliable form of birth control.
9. Women of childbearing age if post tubal ligation or surgical menopause.
10. Able to consent.
11. Willing to perform self-monitoring of glucose.
12. Willing to attend study visits.
13. Written informed consent to participate in the study.
14. Agreement to maintain prior diet and exercise throughout the full course of the study.
Exclusion Criteria
2. Confirmed gastroparesis or taking medications affecting gastric motility.
3. A1c \<7.0% or \>9.0%.
4. Recurrent severe hypoglycemia or hypoglycemic unawareness.
5. CHF.
6. Creatinine clearance \<30 ml/min.
7. History of MI \<6 mos prior to enrollment.
8. History of ventricular arrhythmia.
9. History of cancer or chemotherapy \<6 mos prior to enrollment.
10. Laboratory abnormalities as follows:
1. Liver enzymes \>3X ULN.
2. Hematocrit less than 30.
3. Serum creatinine \>2.5 mg/dl.
4. Fasting triglycerides \>500 mg/dl.
11. Cirrhosis.
12. Pregnancy or nursing.
13. Inability to provide consent.
14. Unwilling to attend study visits.
15. Unwilling to perform self-monitoring of glucose.
16. Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening.
17. Investigational drug treatment within 3 months prior to screening.
18. Donation of blood, significant blood loss or transfusion within 3 months of screening.
19. History of acromegaly or Cushing's syndrome.
20. Use of prohibited concomitant medications.
21. Type 1 diabetes mellitus.
22. Acute metabolic complication (hyperosmolar state) \<6 months prior to screening.
18 Years
80 Years
ALL
No
Sponsors
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Amylin Pharmaceuticals, LLC.
INDUSTRY
Cheryl Rosenfeld, DO
OTHER
Responsible Party
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Cheryl Rosenfeld, DO
Principal Investigator
Principal Investigators
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Cheryl Rosenfeld, DO
Role: PRINCIPAL_INVESTIGATOR
North Jersey Endocrine Consultants
Jeffrey Rothman, MD
Role: PRINCIPAL_INVESTIGATOR
University Physicians Group Research
Alan Schorr, DO
Role: PRINCIPAL_INVESTIGATOR
St. Mary's Medical Center
Locations
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North Jersey Endocrine Consultants
Denville, New Jersey, United States
University Physicians Group
Staten Island, New York, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
Countries
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Other Identifiers
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DEFCon2
Identifier Type: -
Identifier Source: org_study_id