Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 1 Diabetes
In brief
To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations
Key facts
- Study ID
- NCT01708044
- Run by
- AstraZeneca
- People needed
- 32
- Starts
- 2012-11-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2014-10-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is 18 to 70 years old
- Is male, or is female and meets all the following criteria:
- Not breastfeeding
- 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
You may not qualify if…
- 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:
- Any antihyperglycemic agent other than insulin
- Drugs that directly affect gastrointestinal motility (e.g., anticholinergic agents such as atropine)
- 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:
- Hepatic disease
- Renal disease
- Gastrointestinal disease
- Pulmonary disease
- Organ transplantation
- 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).
Where it is running
- Research Site — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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