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

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Placebo; Drug: Pramlintide acetate

• Registration Number: NCT01708044
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Start: 2012-11
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pramlintide 9 mcg per unit of insulin dose	Pramlintide acetate	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.
Pramlintide 6 mcg per unit of insulin dose	Pramlintide acetate	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.
Pramlintide 12 mcg per unit of insulin dose	Pramlintide acetate	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Portland, Oregon, United States