Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00108004 | Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 400 | — | — | Apr 1, 2003 | Jun 1, 2005 | May 21, 2015 | 48 | United States |
| NCT00313183 | A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus | PHASE2 | COMPLETED | 12 | — | — | Apr 1, 2006 | Aug 1, 2007 | Mar 6, 2015 | 3 | United States |
| NCT02500979 | Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus | PHASE1 | COMPLETED | 34 | — | — | Aug 17, 2015 | Aug 5, 2016 | Nov 2, 2018 | 3 | United States |
To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.
To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy
24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period.
| Arm | Type | Description |
|---|---|---|
| Pramlintide | EXPERIMENTAL | Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43-mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative |
| 1 | EXPERIMENTAL | single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects |
| Pramlintide acetate & regular insulin | EXPERIMENTAL | Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL |
| Placebo and regular insulin | PLACEBO_COMPARATOR | Placebo is similar sterile solution without pramlintide. |
| Name | Type | Description |
|---|---|---|
| pramlintide acetate | DRUG | Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial. |
| Placebo | DRUG | Placebo administered by separate pump |
| Lispro insulin U-100 | DRUG | Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5) |
| Regular insulin U-100 | DRUG | Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump |
Inclusion Criteria: * The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for ...