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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Other: Placebo; Drug: Pramlintide acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01708044

D5570C00001

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 4 patient groups, including a placebo group

Pramlintide 6 mcg per unit of insulin dose

Experimental group

Description:

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.

Treatment:

Drug: Pramlintide acetate

Pramlintide 9 mcg per unit of insulin dose

Experimental group

Description:

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.

Treatment:

Drug: Pramlintide acetate

Pramlintide 12 mcg per unit of insulin dose

Experimental group

Description:

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.

Treatment:

Drug: Pramlintide acetate

Placebo

Placebo Comparator group

Treatment:

Other: Placebo