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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
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes
Drug: Pramlintide acetate
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: November 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Drug: Pramlintide acetate
Placebo Comparator: Placebo Other: Placebo
Placebo Comparator

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708044

Locations
United States, Oregon
Research Site
Portland, Oregon, United States
Sponsors and Collaborators
AstraZeneca
Juvenile Diabetes Research Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01708044     History of Changes
Other Study ID Numbers: D5570C00001
Study First Received: October 12, 2012
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Pramlintide,
insulin,
type 1 diabetes,
reduction in postprandial glucose,
pramlintide:insulin dose-ratio

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Islet Amyloid Polypeptide
Pramlintide
Anti-Obesity Agents
Appetite Depressants
Central Nervous System Agents
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014