Effects of Metreleptin in Type 1 Diabetes Mellitus

Stopped early · Phase 1

Conditions studied: Type 1 Diabetes

In brief

This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with the aim of lowering the total insulin requirements and suppressing the steep fluctuations typically associated with Type 1 Diabetes.

Key facts

Study ID

NCT01268644

Run by

University of Texas Southwestern Medical Center

People needed

8

Starts

2010-09-01

Expected to finish

2014-08-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All of the following criteria are to be fulfilled for inclusion of an individual in the study. An eligible individual:
• Is male or female and is 18 to 50 years of age
• Has been diagnosed with T1DM for at least 1 year. Diagnosis of T1DM will be based on clinical criteria including: insulin-dependence within 6 months of the onset, history of prior episode of ketoacidosis, previous documentation of positive serum islet cell autoantibodies or low or undetectable serum C-peptide levels.
• Has an HbA1c 7.0 to 10.0 %, inclusive
• Currently on insulin pump or on a combination of basal (long-acting insulin preparation) and pre-prandial (short-acting insulin preparation) insulin therapy
• Is male, or if female of childbearing potential, is non-lactating, and has a negative pregnancy test (human chorionic gonadotropin, beta subunit [βhCG]) result at screening (Visit 1) and Visit 2 regardless of menopausal status (If female and of childbearing potential [including peri menopausal women who have had a menstrual period within one year], must practice and be willing to continue to practice appropriate birth control [defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner] during the entire duration of the study.)
• Has a BMI < 27 kg/m2
• Has clinical laboratory test values (clinical chemistry, hematology, and urinalysis) judged to be not clinically significant by the investigator at screening (Visit 1)
• Has a physical examination and electrocardiogram (ECG) with no clinically significant abnormalities as judged by the investigator

You may not qualify if…

• Has a fasting serum triglyceride concentration >400 mg/dL at screening
• Has hypoglycemia unawareness (Loss of consciousness due to hypoglycemia without preceding symptoms or recent history of blood glucose <50 mg/dl without symptoms)
• Currently abuses drugs or alcohol, or has a history of abuse that in the investigator's opinion could cause the individual to be noncompliant with study procedures, or has a positive urine screen for drugs of abuse at screening (Visit 1)
• Has chronic renal insufficiency with serum creatinine > 2 mg/dL
• Has a history of weight loss (>3%) in the last 3 months
• Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program
• Has a sitting blood pressure >160/95 mmHg (either systolic or diastolic) at screening (Visit 1)
• Has a clinically significant history or presence of any of the following conditions:
• Active cardio- or cerebrovascular disease
• Active pulmonary disease
• Hepatic disease defined as follows:
• At screening (Visit 1), alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase > three times the upper limit of normal (elevated Liver Function Test values suggestive of obesity related non-alcoholic fatty liver disease may not be exclusionary)
• The presence of any other co morbid disorders that, in the opinion of the investigator, would interfere with the subject's compliance of study procedures
• Clinically significant malignancies within 5 years of screening (Visit 1)
• Chronic infections (e.g., HIV [human immunodeficiency virus] or tuberculosis)
• Has received any investigational drug within 30 days or within a period corresponding to five half-lives of that drug, whichever is greater, before screening (Visit 1)
• Has had major surgery or a blood transfusion within 2 months before screening (Visit 1) or has a hematocrit < 30%
• Has a known hypersensitivity to any of the components of the study treatment (e.g. has a known hypersensitivity to E. Coli derived proteins
• Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site
• Is employed by Amylin Pharmaceuticals, Inc., (i.e., an employee, temporary contract worker, or designee responsible for the conduct of the study)
• Has previously received treatment with recombinant leptin (metreleptin or Fc leptin)

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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