← Trials/Trial dossier/NCT01137695

UnknownPhase 3

Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus

Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus

Asset

Pramlintide

Amylin analog

Listed sites

3

Recruiting sites

Enrollment

40

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥30HbA1c 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

NCT IDNCT01137695
Org study IDDEFCon2

Timeline

Milestones

Study first posted2010-06-04estimated
Last update posted2011-10-14estimated
Study start2010-05 (month precision)
Primary completion2012-01estimated (month precision)
Study completion2012-04estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
2
Weight & body composition
1
Glycemic / diabetes
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight loss

Time frame:6 months

descriptive, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint/low confidence

Glucose control

Time frame:6 months

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

adverse effects

Time frame:6 months

threshold achievement, event

componentsNausea, Severe hypoglycemia, Documented hypoglycemia

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

amylin level

Time frame:initial

descriptive

Secondary/protocol endpoint/low confidence

glucagon level

Time frame:6 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.