Effects of Metreleptin in Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01268644|
Recruitment Status : Terminated (Sponsor request)
First Posted : December 31, 2010
Last Update Posted : May 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Leptin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Single Center Pilot Study to Study Teh Effects of Metreleptin Administration in Patients With Type 1 Diabetes Mellitus ( T1DM ).|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||August 2014|
Experimental: active open label Leptin
Active open label Leptin for type 1 Diabetes
weight based sub-cutaneous injection twice daily of Leptin
Other Name: Metreleptin
- Change in HgbA1c [ Time Frame: 3 months ]The study will assess whether the addition of metreleptin to insulin monotherapy for a period of 3 months will reduce HbA1c and/or will reduce the amount of insulin necessary to maintain the same or a better glucose control as prior to the initiation of metreleptin therapy
- Mean and standard deviation of blood glucose [ Time Frame: 6 months ]To determine if there are changes in the mean blood glucose and the standard deviation of blood glucose as assessed by continuos glucose monitoring and frequent sampling.
- change in liver and muscle fat as measured by Liver and soleus triglycerides on MRS. [ Time Frame: 6 months ]Change in the soleus and liver Tg as measured by spectroscopy evaluated 4 times over the 6 months of therapy.
- Change in Glycomark [ Time Frame: Glycomark as measured at every visit from baseline until study end. ]Glycomark as a more sensitive measure of glycemic control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268644
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Abhimanyu Garg, M.D.||UT Southwestern Medical Center|