Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01708044
First received: October 12, 2012
Last updated: October 17, 2014
Last verified: October 2014

October 12, 2012
October 17, 2014
November 2012
September 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01708044 on ClinicalTrials.gov Archive Site
  • Incremental AUC (0-3 h) of plasma glucagon [ Time Frame: 0-3 hrs compared to Placebo ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • PK of pramlintide [ Time Frame: 0-3 hrs compared to Placebo ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 0-3 hrs compared to Placebo ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: Pramlintide acetate
  • Other: Placebo
    Placebo Comparator
  • Experimental: Pramlintide 6 mcg per unit of insulin dose
    The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 6 mcg for each unit of insulin.
    Intervention: Drug: Pramlintide acetate
  • Experimental: Pramlintide 9 mcg per unit of insulin dose
    The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 9 mcg for each unit of insulin.
    Intervention: Drug: Pramlintide acetate
  • Experimental: Pramlintide 12 mcg per unit of insulin dose
    The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 12 mcg for each unit of insulin.
    Intervention: Drug: Pramlintide acetate
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2013
September 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01708044
D5570C00001
No
AstraZeneca
AstraZeneca
Juvenile Diabetes Research Foundation
Not Provided
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP