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
1 other identifier
interventional
32
1 country
1
Brief Summary
To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 20, 2014
October 1, 2014
10 months
October 12, 2012
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment
AUC 0-3 hrs compared to Placebo
Secondary Outcomes (4)
Incremental AUC (0-3 h) of plasma glucagon
0-3 hrs compared to Placebo
Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.
0-3 hrs compared to Placebo
PK of pramlintide
0-3 hrs compared to Placebo
Safety
0-3 hrs compared to Placebo
Study Arms (4)
Pramlintide 6 mcg per unit of insulin dose
EXPERIMENTALThe 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.
Pramlintide 9 mcg per unit of insulin dose
EXPERIMENTALThe 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.
Pramlintide 12 mcg per unit of insulin dose
EXPERIMENTALThe 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.
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (1)
Research Site
Portland, Oregon, United States
Related Publications (1)
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.
PMID: 26040429DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2012
First Posted
October 16, 2012
Study Start
November 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
October 20, 2014
Record last verified: 2014-10