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Type 1 DiabetesPhase 1NCT01268644

Effects of Metreleptin in Type 1 Diabetes Mellitus

A Phase 1 study testing Leptin in people with Type 1 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Leptin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Sep 2010to Aug 2014
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.)
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Open Label Single Center Pilot Study to Study Teh Effects of Metreleptin Administration in Patients With Type 1 Diabetes Mellitus ( T1DM ).

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.

Read the detailed description

The adipocyte hormone, leptin, has been shown to restore the health and glucoregulation of near-death, insulin deficient diabetic rodents. This makes leptin the only hormone, since the discovery of insulin in 1922, with this capability. Leptin normalizes the hyperglucagonemia of diabetes and reduces lipogenesis and cholesterologenenesis. Treatment of diabetic rodents with a combination of leptin and insulin, leads to a stable pattern of glucose control with reduced insulin requirements, as opposed to the high glucose variability that characterizes the treatment of type 1 diabetes with supraphysiologic doses of insulin alone. As such, we will initiate a pilot clinical trial to test combination leptin and insulin therapy in type 1 diabetes. Fifteen leptin sensitive patients (body mass index <27 kg/m²) with uncontrolled diabetes (HbA1c 7.0 to 10.0 %) will be treated with slightly supraphysiologic doses of recombinant human leptin (Amylin Pharmaceuticals). Subjects will be compared to themselves before and after treatment with leptin. Endpoint variables include HbA1c, change in daily insulin dose, mean and standard deviation of blood glucose from inpatient glucose monitoring and glucose meter download. We will also assess effects of leptin therapy on energy intake as assessed by 3-day food record and body weight and fat by DEXA. Intramyocellular and intrahepatic lipid concentration by 1H-MRS will be assessed before and after 3 months of metreleptin therapy. A satiety analysis will be employed. In addition, plasma hormones and inflammatory biomarkers will be assayed during the course of this study.

Conditions
Type 1 Diabetes
Being tested
Leptin
Keywords
Type 1 Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LeptinDrug

    Also called Metreleptin

    weight based sub-cutaneous injection twice daily of Leptin

Study groups in NCT01268644
Study groupRoleWhat they receive
active open label LeptinExperimentalActive open label Leptin for type 1 Diabetes
Receives: Drug: Leptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

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

    Measured: Baseline and 12 weeks

Secondary outcomes (3)

  1. Weight

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

    Measured: Baseline to 12 weeks

  2. Insulin Dose

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

    Measured: Baseline to 12 weeks

  3. Change in HbA1c From Baseline to Week 20 on Leptin Therapy

    Change in Hba1c after 20 weeks on Leptin Therapy compared to Baseline value. With ongoing metreleptin therapy, the concomitant basal insulin dose was actively reduced by 50% after week 12.

    Measured: Baseline to Week 20 (On leptin)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2013
  4. Study completionAug 2014

Why it stopped: Sponsor request

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01268644
Sponsor's protocol ID
FBA937
Other IDs
CTRC # 953
Status last verified
Jul 2019
First submitted
29 Dec 2010
Last updated
28 Aug 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28223297

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Leptin in people with Type 1 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01268644, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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