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Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT02151461
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : February 2, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
NuSirt Biopharma

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Low Metformin
Drug: Metformin
Drug: Mid Metformin
Drug: High Metformin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of four treatment arms in the ratio of 1:1:1:1 (A:B:C:D). The randomization was stratified by fasting plasma glucose (≥126 mg/dL to <200 mg/dL, and ≥200 mg/dL to ≤220 mg/dL), as well as metformin experience. Yes/No history of abdominal side effects.

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
FDC125 Leucine 1100mg +Metformin 125mg
FDC250 Leucine 1100mg +Metformin 250mg
FDC500 Leucine 1100mg +Metformin 500mg
Control Day 1-14: 500mg, Day 15-28: 850mg

Participant Flow:   Overall Study
    FDC125   FDC250   FDC500   Control
STARTED   24   25   24   23 
COMPLETED   18   24   21   19 
NOT COMPLETED   6   1   3   4 
Adverse Event                5                1                0                2 
Lost to Follow-up                0                0                1                1 
Withdrawal by Subject                1                0                1                1 
Treatment discontinuation                0                0                1                0 



  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.
Subjects who had adequate exposure to the randomized study medication during the 4-week treatment period (Day 1/Visit 4 to Day 28/Visit 7) and had adequately complied with the protocol as assessed by the sponsor prior to database lock.The groups in Metformin experience are mutually exclusive.

Reporting Groups
  Description
FDC125 Leucine 1100mg +Metformin 125mg
FDC250 Leucine 1100mg +Metformin 250mg
FDC500 Leucine 1100mg +Metformin 500mg
Control Day 1-14: 500mg, Day 15-28: 850mg
Total Total of all reporting groups

Baseline Measures
   FDC125   FDC250   FDC500   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   25   24   23   96 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 53.6  (9.87)   55.1  (8.3)   56.1  (10.08)   59.3  (9.64)   56.0  (9.56) 
[1] Subjects who met the inclusion criteria, with FPG>126 to <220 mg/dL, HbA1c>7 to<8.5% and BMI<40kgm2
Age, Customized 
[Units: Participants]
Count of Participants
         
<65 years   19   21   18   17   75 
≥65 years   5   4   6   6   21 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      15  62.5%      13  52.0%      13  54.2%      10  43.5%      51  53.1% 
Male      9  37.5%      12  48.0%      11  45.8%      13  56.5%      45  46.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      14  58.3%      15  60.0%      12  50.0%      12  52.2%      53  55.2% 
Not Hispanic or Latino      10  41.7%      10  40.0%      12  50.0%      11  47.8%      43  44.8% 
Unknown or Not Reported      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%      1   4.0%      0   0.0%      0   0.0%      1   1.0% 
Asian      0   0.0%      1   4.0%      0   0.0%      1   4.3%      2   2.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   8.3%      3  12.0%      5  20.8%      6  26.1%      16  16.7% 
White      22  91.7%      20  80.0%      19  79.2%      16  69.6%      77  80.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 87.049  (17.3747)   88.584  (19.4687)   84.493  (19.8622)   86.777  (16.5700)   86.745  (18.1696) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.142  (4.7113)   30.985  (5.5766)   29.927  (5.1504)   31.146  (4.5838)   30.798  (4.9778) 
Fasting Plasma Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 194.3  (50.86)   170.3  (44.28)   182.8  (40.97)   184.7  (50.87)   182.9  (46.93) 
Haemoglobin A1c (HbA1c) 
[Units: %]
Mean (Standard Deviation)
 7.95  (0.837)   8.01  (0.713)   7.82  (0.563)   8.24  (0.831)   8.00  (0.747) 
Previous Metformin experience 
[Units: Participants]
Count of Participants
         
No Previous Experience   4   1   5   3   13 
No Abdominal side effects from prior Metformin   18   20   17   16   71 
Had Abdominal side effects from prior Metformin   2   4   2   4   12 


  Outcome Measures

1.  Primary:   Change From Baseline to Day 28 in Absolute Plasma Glucose Area Under the Curve (AUC) 0-3hr   [ Time Frame: 0, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs and 3 hrs ]

2.  Secondary:   Change From Baseline to Day 28 in Incremental Plasma Glucose Area Under the Curve (AUC)   [ Time Frame: Baseline, Day 28 ]

3.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: Baseline, Day 28 ]

4.  Secondary:   Change in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, Day 28 ]

5.  Secondary:   Change in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline, Day 28 ]

6.  Secondary:   Change In 7-Point Glucose Profiles   [ Time Frame: Baseline, Day 7, Day 21, Day 28 ]

7.  Secondary:   Plasma Insulin Absolute and Incremental Meal Tolerance Test Area Under the Curve (AUC) 0-2hr   [ Time Frame: Baseline,Day 28 ]

8.  Secondary:   Change From Baseline to Day 28 in Fasting Plasma Insulin Concentration   [ Time Frame: Baseline, Day 28 ]


  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: Barbara Cannon
Organization: NuSirt Biopharma
phone: 6156567898
e-mail: BCannon@nusirt.com



Responsible Party: NuSirt Biopharma
ClinicalTrials.gov Identifier: NCT02151461     History of Changes
Other Study ID Numbers: NS-0100-01
First Submitted: May 28, 2014
First Posted: May 30, 2014
Results First Submitted: September 21, 2017
Results First Posted: February 2, 2018
Last Update Posted: February 27, 2018