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Trial · Interventional

Status unknownPhase 3Registry data

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

NCTNCT01137695 (opens ClinicalTrials.gov in a new tab)Other idDEFCon2
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Overview

Status
Status unknown
Phase
Phase 3
Enrollment
40 participants (estimated)
Sponsor
Cheryl Rosenfeld, DO · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2010
Primary completion
Jan 2012 (estimated)
Completion
Apr 2012 (estimated)
First posted
4 Jun 2010 (estimated)
Last update posted
14 Oct 2011 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 3

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

    NCT01137695

    May 2010 to est. Apr 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 glucose control require higher than FDA approved dosage. 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.

Interventions

  • PramlintideDrug
  • PramlintideDrug
  • PramlintideDrug
  • PramlintideDrug

Arms4

  • Active comparator

    Symlin Naive, Usual Dose

    Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.

  • Experimental

    Symlin Naive, Dose Escalation

    Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.

  • Active comparator

    Symlin treated, Usual Dose

    pramlintide 120 mcg three times daily in patients who have been treated with pramlintide 120 mcg prior to the trial.

  • Experimental

    Symlin Treated, Dose Escalation

    pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glucose control

    Time frame · 6 months

    Registry description

    A1c Fasting plasma glucose Post-prandial glucose Glycomark

Secondary outcomes(4)

  1. Weight loss

    Time frame · 6 months

    Registry description

    Weight, BMI, Waist circumference.

  2. amylin level

    Time frame · initial

    Registry description

    does initial blood amylin level correlate with need for higher dose pramlintide?

  3. glucagon level

    Time frame · 6 months

    Registry description

    Does change in glucagon level correlate with glycemic response.

  4. adverse effects

    Time frame · 6 months

    Registry description

    Whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg TID (as compared to the clinical practice study) - GI: nausea 30% and Hypoglycemia: medically assisted 0.7% or patient ascertained 0.7%.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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