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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Single masking
Countries
1 country

United States

Start
Nov 2012
Primary completion
Sept 2013
Completion
Sept 2013
First posted
16 Oct 2012 (estimated)
Last update posted
20 Oct 2014 (estimated)
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 1

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

    NCT01708044

    Nov 2012 to Sept 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Pramlintide acetateDrug
  • PlaceboOther

Arms4

  • 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.

  • 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.

  • 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.

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

Secondary outcomes(4)
  1. Incremental AUC (0-3 h) of plasma glucagon

    Time frame · 0-3 hrs compared to Placebo

  2. 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

  3. PK of pramlintide

    Time frame · 0-3 hrs compared to Placebo

  4. Safety

    Time frame · 0-3 hrs compared to Placebo

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

4 results

Fixed ratio dosing of pramlintide with regular insulin before a standard meal in patients with type 1 diabetes.

Riddle et al. 2015Diabetes, obesity & metabolismcited by 25

PMID 26040429PMC4758401DOI 10.1111/dom.12504PUB-26040429

Free to read · publisher termsCC BY-NC-ND4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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