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Trial record 71 of 126 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02093221
Recruitment Status : Terminated (Wk 52 primary endpoint results would be unaffected by follow-up data so trial was discontinued prior to wk 104. No safety data was collected after wk 52.)
First Posted : March 20, 2014
Results First Posted : April 19, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Biological: 180 mg/kg Alpha1-PI
Biological: 90 mg/kg Alpha1-PI
Biological: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alpha1-PI 180 mg/kg/wk, 26 Weeks

180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.

180 mg/kg Alpha1-PI

180 mg/kg/wk Alpha1-PI, 13 Weeks

180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.

180 mg/kg Alpha1-PI

90 mg/kg/wk Alpha1-PI, 26 Weeks

90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.

90 mg/kg Alpha1-PI

90 mg/kg/wk Alpha1-PI, 13 Weeks

90 mg/kg weekly infusions of Alpha1-PI for 13 weeks

90 mg/kg Alpha1-PI

Placebo

Weekly infusions of placebo for 13 or 26 weeks.

Placebo


Participant Flow:   Overall Study
    Alpha1-PI 180 mg/kg/wk, 26 Weeks   180 mg/kg/wk Alpha1-PI, 13 Weeks   90 mg/kg/wk Alpha1-PI, 26 Weeks   90 mg/kg/wk Alpha1-PI, 13 Weeks   Placebo
STARTED   15   16   15   15   15 
COMPLETED   5   8   6   7   7 
NOT COMPLETED   10   8   9   8   8 
Adverse Event                1                0                0                0                0 
Withdrawal by Subject                1                1                4                1                1 
Lost to Follow-up                2                0                1                1                0 
Death                0                1                0                0                0 
Protocol Violation                0                1                0                0                0 
Study termination                6                5                4                6                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Alpha1-PI 180 mg/kg/wk, 26 Weeks

180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.

180 mg/kg Alpha1-PI

180 mg/kg/wk Alpha1-PI, 13 Weeks

180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.

180 mg/kg Alpha1-PI

90 mg/kg/wk Alpha1-PI, 26 Weeks

90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.

90 mg/kg Alpha1-PI

90 mg/kg/wk Alpha1-PI, 13 Weeks

90 mg/kg weekly infusions of Alpha1-PI for 13 weeks

90 mg/kg Alpha1-PI

Placebo

Weekly infusions of placebo for 13 or 26 weeks.

Placebo

Total Total of all reporting groups

Baseline Measures
   Alpha1-PI 180 mg/kg/wk, 26 Weeks   180 mg/kg/wk Alpha1-PI, 13 Weeks   90 mg/kg/wk Alpha1-PI, 26 Weeks   90 mg/kg/wk Alpha1-PI, 13 Weeks   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   16   15   15   15   76 
Age, Customized 
[Units: Participants]
Count of Participants
           
6 - 11 years   2   3   3   3   2   13 
12 - 17 years   7   7   7   7   6   34 
18 - 35 years   6   6   5   5   7   29 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      6  40.0%      8  50.0%      9  60.0%      4  26.7%      4  26.7%      31  40.8% 
Male      9  60.0%      8  50.0%      6  40.0%      11  73.3%      11  73.3%      45  59.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      3  20.0%      1   6.3%      3  20.0%      2  13.3%      0   0.0%      9  11.8% 
Not Hispanic or Latino      12  80.0%      15  93.8%      12  80.0%      13  86.7%      15 100.0%      67  88.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   6.3%      0   0.0%      2  13.3%      0   0.0%      3   3.9% 
White      14  93.3%      14  87.5%      15 100.0%      13  86.7%      15 100.0%      71  93.4% 
More than one race      1   6.7%      1   6.3%      0   0.0%      0   0.0%      0   0.0%      2   2.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Change From Baseline in Mixed Meal Tolerance Test (MMTMT) Stimulated C-peptide 2 Hour Area Under the Concentration-time Curve (AUC)   [ Time Frame: Baseline, Week 52 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink) ]

2.  Secondary:   Change From Baseline for MMTT Stimulated C-peptide 2h AUC   [ Time Frame: Baseline, Weeks 14, 27, 39, 69, 87, and 104 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink) ]

3.  Secondary:   Change From Baseline for HbA1c Levels   [ Time Frame: Baseline, Weeks 14, 27, 39, 52, 69, 87, and 104 ]

4.  Secondary:   Number of Subjects With Overall Severe Hypoglycemic Episodes   [ Time Frame: 104 weeks ]

5.  Secondary:   Change From Baseline for Mean Daily Insulin Dose Requirements   [ Time Frame: Baseline, Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104 ]

6.  Secondary:   Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime   [ Time Frame: Baseline, Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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:  
Name/Title: Kimberly Steinmann, MD
Organization: Grifols Therapeutics LLC
phone: 919-308-5444
e-mail: kimberly.steinmann@grifols.com



Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT02093221     History of Changes
Other Study ID Numbers: GTI1302
First Submitted: March 11, 2014
First Posted: March 20, 2014
Results First Submitted: March 23, 2018
Results First Posted: April 19, 2018
Last Update Posted: September 5, 2018