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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 curves

Efficacy 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

Page last updated: August 23, 2015

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