Current partner codePEPTIDESDE
NCT01708044·Phase 1·INTERVENTIONAL

Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM

Status

Completed

Phase

Phase 1

Enrollment

32

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations

Interventions

Treatment arms and agents.

DRUG

Pramlintide acetate

OTHER

Placebo

Placebo Comparator

Timeline

From registration to results.

  1. First posted

    Oct 16, 2012

  2. Study start

    Nov 2012

  3. Primary completion

    Sep 2013

  4. Study completion

    Sep 2013

  5. Results posted

    Not reported

  6. Registry updated

    Oct 20, 2014

Outcomes

What the study measures.

Primary outcomes

Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment

Time frame · AUC 0-3 hrs compared to Placebo

Secondary outcomes

Incremental AUC (0-3 h) of plasma glucagon

Time frame · 0-3 hrs compared to Placebo

Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.

Time frame · 0-3 hrs compared to Placebo

PK of pramlintide

Time frame · 0-3 hrs compared to Placebo

Safety

Time frame · 0-3 hrs compared to Placebo

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Is 18 to 70 years old * Is male, or is female and meets all the following criteria: 1. Not breastfeeding 2. Negative pregnancy test result and, if of childbearing potential, must practice and be willing to continue to practice appropriate birth control * Has been diagnosed with type 1 diabetes mellitus for at least 1 year and not achieving glycemic goal while on MDI of insulin * Has HbA1c between 7.0% and 9.0% * Has been on MDI of regular insulin, at a dose not to exceed 10 units/breakfast for at least 3 months or has been on continuous subcutaneous insulin infusion (CSII), at a dose not to exceed 10 units/breakfast, for at least 3 months and is willing to switch to an MDI insulin regimen for 1 day prior to enrollment and through the study * Has a body mass index (BMI) \<30 kg/m2 Exclusion Criteria: * Has experienced recurrent severe hypoglycemia requiring assistance within 6 months before Visit 1 Screening * Has a history of hypoglycemia unawareness * Has a confirmed diagnosis of gastroparesis * Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications: 1. Any antihyperglycemic agent other than insulin 2. Drugs that directly affect gastrointestinal motility (e.g., anticholinergic agents such as atropine) 3. Drugs that slow the intestinal absorption of nutrients (e.g., α-glucosidase inhibitors. * Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions: 1. Hepatic disease 2. Renal disease 3. Gastrointestinal disease 4. Pulmonary disease 5. Organ transplantation 6. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus) * Is currently treated or has been previously treated with SYMLIN/pramlintide or has participated in a SYMLIN/pramlintide clinical study within 3 months of Visit 1 (Screening). * Has any clinically significant laboratory findings or medical history that may affect successful completion of the study and/or personal well-being * Has donated blood within 2 months or is planning to donate blood during the study. * Has had a major surgery or a blood transfusion within 2 months * Has received any investigational drug within 1 month * Has known allergies or hypersensitivity to any component of study treatment. * Is an immediate family member of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with the study at the clinical study site. * Is employed by Amylin Pharmaceuticals, Inc (Amylin) (that is an employee, temporary contract worker, or designee responsible for the conduct of the study).

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Portland, Oregon, United States

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.