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Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus
Lead sponsor
Asset
Pramlintide
Amylin analog
Listed sites
3
Recruiting sites
—
Enrollment
40
estimated
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥30•HbA1c 7-9%
Primary endpoint
•Glucose control
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age 18-80 years.
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
1. Age <18 or >80 years.
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.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointWeight loss
Time frame:6 months
descriptive, improvement
Glycemic / diabetes
1 endpointGlucose control
Time frame:6 months
descriptive, improvement
Safety / tolerability / PK
1 endpointadverse effects
Time frame:6 months
threshold achievement, event
componentsNausea, Severe hypoglycemia, Documented hypoglycemia
Other (unclassified)
2 endpointsamylin level
Time frame:initial
descriptive
glucagon level
Time frame:6 months
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.