Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Pramlintide acetate; Placebo; Lispro insulin U-100; Regular insulin U-100
Intervention description: Pramlintide acetate administered by a separate pump; Placebo administered by separate pump; Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5); Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Pramlintide; Islet Amyloid Polypeptide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 1 Diabetes Mellitus; Pramlintide

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.
    

Eligibility 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.

          -  Pregnancy confirmed by a positive pregnancy test, or otherwise verified.

          -  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