Clinical trial NCT01708044: Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM
Official title: A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: Pramlintide,
insulin,
type 1 diabetes,
reduction in postprandial glucose,
pramlintide:insulin dose-ratio
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2012-10-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment
timeFrame: AUC 0-3 hrs compared to Placebo
Secondary outcomes:
measure: Incremental AUC (0-3 h) of plasma glucagon
timeFrame: 0-3 hrs compared to Placebo
measure: Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.
timeFrame: 0-3 hrs compared to Placebo
measure: PK of pramlintide
timeFrame: 0-3 hrs compared to Placebo
measure: Safety
timeFrame: 0-3 hrs compared to Placebo
Other outcomes:
Locations:
city: Portland
country: United States
facility: Research Site
state: Oregon
Study officials:
References:
citation: Riddle MC, Yuen KC, de Bruin TW, Herrmann K, Xu J, Ohman P, Kolterman OG. Fixed ratio dosing of pramlintide with regular insulin before a standard meal in patients with type 1 diabetes. Diabetes Obes Metab. 2015 Sep;17(9):904-7. doi: 10.1111/dom.12504. Epub 2015 Jul 8.