Effects of Metreleptin in Type 1 Diabetes Mellitus

NCT01268644 | Terminated Phase 1 Results DMC

• 2 other identifiers: FBA937CTRC # 953
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in Hba1c after 12 weeks on Leptin Therapy compared to Baseline value

  Baseline and 12 weeks

Secondary Outcomes (3)

• Weight

  Baseline to 12 weeks

• Insulin Dose

  Baseline to 12 weeks

• Change in HbA1c From Baseline to Week 20 on Leptin Therapy

  Baseline to Week 20 (On leptin)

Study Arms (1)

active open label Leptin

EXPERIMENTAL

Active open label Leptin for type 1 Diabetes

Drug: Leptin

Interventions

Leptin DRUG

weight based sub-cutaneous injection twice daily of Leptin

Also known as: Metreleptin

active open label Leptin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Juvenile Diabetes Research Foundation: collaborator
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Vasandani C, Clark GO, Adams-Huet B, Quittner C, Garg A. Efficacy and Safety of Metreleptin Therapy in Patients With Type 1 Diabetes: A Pilot Study. Diabetes Care. 2017 May;40(5):694-697. doi: 10.2337/dc16-1553. Epub 2017 Feb 21.

  PMID: 28223297 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Leptin; metreleptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adipokines; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Abhimanyu Garg
• Organization: UT Southwestern Medical Center

abhimanyu.garg@utsouthwestern.edu

2146482895

Study Officials

• Abhimanyu Garg, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division Nutrition and Metabolic Diseases, Professor Internal Medicine

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 31, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-07

Locations

US (1)