DRUG
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.
OTHER
Placebo
Placebo Comparator
Timeline
From registration to results.
First posted
Oct 16, 2012
Study start
Nov 2012
Primary completion
Sep 2013
Study completion
Sep 2013
Results posted
Not reported
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
Publications
Results and literature.
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