Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus
Intervention: Pramlintide acetate (Drug); Placebo (Drug); Lispro insulin U-100 (Drug); Regular insulin U-100 (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Peter Ohman, MD, Study Director, Affiliation: Medical Director AstraZeneca
Overall contact: AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
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 Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Efficacy of pramlintide by measurement of 24-hour mean weighted glucose (MWG) in mg/dL
Secondary outcome: Efficacy of pramlintide by measurement of total area under the 3-hour plasma glucose curvesEfficacy of pramlintide by measurement of percent time spent in the normoglycemic range of blood Efficacy of pramlintide by measurement of incremental area under the 24-hour blood glucose Efficacy of pramlintide by measurement of mean area under the 24-hour plasma glucagon Efficacy of pramlintide by measurement of fasting plasma glucose concentration Pharmacokinetics analysis of pramlintide and insulin by measurement of AUC0-t of pramilintide and insulin Pharmacokinetics analysis of pramlintide and insulin by measurement of Cmax of pramilintide and insulin Pharmacokinetics analysis of pramlintide and insulin by measurement of tmax of pramilintide and insulin Pharmacokinetics analysis of pramlintide and insulin by measurement of average concentrations of pramilintide and insulin
Detailed 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. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Provision of informed consent prior to any study-specific procedures
- Female and/or male aged between 18 and 70 years
- Must have a prior diagnosis of T1DM
- Body mass index (BMI) <30 kg/m2
- Subjects are not on current treatment with pramlintide (Symlin) and have not received
pramlintide during the 6-month period prior to enrollment
- Subjects should be willing to consume all of the components of the standardized meals
administered during the study
- Negative serum pregnancy test for female subjects of childbearing potential
- Female subjects of childbearing potential must be 1 year postmenopausal, surgically
sterile, or using an acceptable method of contraception for the duration of the study
- Male subjects must be surgically sterile or using an acceptable method of
contraception for the duration of the study
Exclusion Criteria:
- Recurrent severe hypoglycemia requiring assistance within 6 months before screening
- A history of hypoglycemia unawareness
- 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 oral antihyperglycemic agent or any other injectable antihyperglycemic agent that
is not insulin
- Drugs that directly affect GI motility (eg, anticholinergic agents such as atropine)
- Drugs that slow the intestinal absorption of nutrients (eg, α-glucosidase inhibitors
- A history of gastric surgery (such as gastric banding, Roux- and Y bypass)
- Is expected to require or undergo treatment with acetaminophen after enrollment and
at any point during the study
- Has experienced diabetic ketoacidosis within the last 24 weeks
- History of hospitalization within the last 6 months for glycemic control (for both
hyperglycemia or hypoglycemia)
- Subject has any significant disease or disorder, which, in the opinion of the
investigator, may either put the subject at risk because of participation in the
study, or may influence the results of the study, or the subject's ability to
participate in the study
- Any clinically relevant abnormal findings, which, in the opinion of the investigator,
may put the subject at risk because of his/her participation in the study.
- Breast feeding
- Positive hepatitis C virus antibody (HCV Ab), hepatitis B virus surface antigen
(HBsAg), hepatitis B virus core antibody (anti-Hbc), or human immunodeficiency virus
1/2 antibody (HIV-1/2 Ab) at Screening
- History of, or current alcohol or drug abuse
- Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate
blood during the study
- Has had a major surgery or a blood transfusion within 2 months before Visit 1
(screening)
- Participation in any clinical study with an investigational drug or new formulation
of a marketed drug during the last 1 month prior to Visit 1
Locations and Contacts
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com Additional Information
Starting date: August 2015
Last updated: August 18, 2015
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