Clinical Trials Logo
  1. Home
  2. Type 1 Diabetes Mellitus
  3. NCT02500979

Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:
A Randomized, Single-Blind, Two-Way Crossover, Placebo-Controlled Phase I Study to Compare the 24-hour Glucose Profile and Safety of Pramlintide and Insulin, Co-Administered in a Fixed-Dose Ratio, Versus Placebo and Insulin in Patients With Type 1 Diabetes Mellitus With Inadequate Glycemic Control

Clinical Trial Summary

This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Clinical Trial Description

Potentially eligible subjects with Type 1 diabetes mellitus who are treated with with a basal-bolus insulin regimen through multiple daily injections or insulin pump at a total daily insulin dose ≤60 U, will be eligible. Visit 1 is approximately 3-6 weeks prior to randomization. Given some variability in HbA1c and C-peptide assays, re-testing for HbA1c and C-peptide can be performed within 18 days from the initial visit. Visit 2 is approximately 2-5 weeks prior to randomization. Subjects are on lispro insulin throughout study except during Visit 4 and Visit 5, the domicile 24 hr treatment period, when they are switched to regular insulin U-100.

Screen failed patients may be re-screened for inclusion in the study, as long as re-screening takes place at least 3 months after the original screening visit. If a subject is re-screened, he/she must continue to meet all inclusion/exclusion criteria. All study procedures of initial Visit 1 must be repeated at the re-screening visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02500979
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date August 17, 2015
Completion date August 5, 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT04476472 - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort N/A
Completed NCT03635437 - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes Phase 1/Phase 2
Completed NCT04909580 - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes N/A
Active, not recruiting NCT00679042 - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol Phase 3
Completed NCT03293082 - Preschool CGM Use and Glucose Variability in Type 1 Diabetes N/A
Completed NCT04016662 - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D) Phase 4
Completed NCT02527265 - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Phase 2
Completed NCT03738865 - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes Phase 3
Completed NCT03240432 - Wireless Innovation for Seniors With Diabetes Mellitus N/A
Completed NCT03168867 - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms) N/A
Completed NCT03674281 - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System N/A
Completed NCT03669770 - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting NCT03682640 - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes Phase 2
Recruiting NCT04096794 - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed NCT02882737 - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus N/A
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Completed NCT02596204 - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring N/A
Completed NCT02562313 - A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog® Phase 1
Completed NCT02558491 - Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM N/A