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Trial record 33 of 2457 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

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
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Drug: Leptin
Enrollment 8
Recruitment Details Patients with T1DM between the 18 and 50 years of age and with a BMI less than 27 kg/m2 and an HbA1c of 7.0–10.0% (53–86 mmol/mol) were eligible for the study.
Pre-assignment Details  
Arm/Group Title Leptin Therapy in T1DM Patients
Hide Arm/Group Description After a 4-week lead-in period, baseline evaluation was conducted at week 0.
Period Title: Baseline Period (Week 0)
Started 8
Completed 8
Not Completed 0
Period Title: Phase A (Weeks 0–12) Leptin Therapy
Started 8
Completed 8
Not Completed 0
Period Title: Phase B (Weeks 12-20) Leptin Therapy
Started 7 [1]
Completed 7
Not Completed 0
[1]
One subject withdrew after 12 weeks .
Period Title: Phase C (Weeks 20-24) Off Leptin Therapy
Started 7
Completed 7
Not Completed 0
Arm/Group Title Week 0 (Baseline)
Hide Arm/Group Description After a 4-week lead-in period, baseline evaluation was conducted at week 0.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
33  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 8 participants
70.7  (5.9)
Leptin  
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 8 participants
23
(6 to 34)
Insulin dose  
Mean (Standard Deviation)
Unit of measure:  Units/day
Number Analyzed 8 participants
45.9  (11.5)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  % of Hemoglobin
Number Analyzed 8 participants
7.6  (0.4)
1.Primary Outcome
Title HbA1c
Hide Description Change in Hba1c after 12 weeks on Leptin Therapy compared to Baseline value
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Therapy Week 12
Hide Arm/Group Description:
Change in HbA1c after 12 weeks on Leptin Therapy from Baseline.
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: % of hemoglobin
-0.19
(-0.44 to 0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leptin Therapy Week 12
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments P value comparing baseline to week 12
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Weight
Hide Description Change in Body Weight after 12 weeks on Leptin Therapy compared to Baseline value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew after 12 weeks.
Arm/Group Title Leptin Therapy in TIDM Patients
Hide Arm/Group Description:
Change in Body Weight after 12 weeks on Leptin Therapy compared to Baseline value
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: kg
-2.60
(-4.6 to -0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leptin Therapy in TIDM Patients
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments P value comparing week 0 with week 12.
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Insulin Dose
Hide Description Change in Insulin dose after 12 weeks on Leptin Therapy compared to Baseline value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew after 12 weeks.
Arm/Group Title Leptin Therapy in TIDM Patients
Hide Arm/Group Description:
Change in Daily insulin dose after 12 weeks on Leptin Therapy compared to insulin dose during the Baseline period
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: units/day
-5.84
(-10.1 to -1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leptin Therapy in TIDM Patients
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P value comparing week 0 to week 12.
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Change in HbA1c From Baseline to Week 20 on Leptin Therapy
Hide Description 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.
Time Frame Baseline to Week 20 (On leptin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 20 (On Leptin)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Mean (95% Confidence Interval)
Unit of Measure: % of Hemoglobin
-0.04
(-0.31 to 0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Week 20 (On Leptin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Adverse event data was collected for 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description After a 4-week lead-in period, baseline evaluation was conducted at week 0.
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Overall Study
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Infections and infestations   
Injection site reaction  [1]  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
[1]
One subject withdrew after 12 weeks as a result of injection site reaction.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Abhimanyu Garg
Organization: UT Southwestern Medical Center
Phone: 2146482895
EMail: abhimanyu.garg@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Abhimanyu Garg, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01268644     History of Changes
Other Study ID Numbers: FBA937
CTRC # 953 ( Other Grant/Funding Number: JDRF and Amylin )
First Submitted: December 29, 2010
First Posted: December 31, 2010
Results First Submitted: December 31, 2018
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019