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Metformin at the Cellular Level and Dosing for Diabetes Mellitus (DM)

This study has been terminated.
(All investigators/co-investigators relocating to other institutions.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01876992
First Posted: June 13, 2013
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 2, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Diabetes
Pre-diabetes
Obesity
Intervention: Drug: Metformin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited through the Clinical Research Center.

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
Metformin

Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.

For children <50kg:

Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm, Week 8:500mg po bid.

For children ≥50kg:

Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.

For adults:

Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.

Metformin

Obese Controls

Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.

There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn.


Participant Flow:   Overall Study
    Metformin   Obese Controls
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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
Metformin

Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.

For children <50kg:

Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm

, Week 8:500mg po bid.

For children ≥50kg:

Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.

For adults:

Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.

Metformin

Obese Controls

Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.

There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn.

Total Total of all reporting groups

Baseline Measures
   Metformin   Obese Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5 100.0%      5 100.0%      10 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 32 
 (19 to 44) 
 36 
 (22 to 38) 
 34 
 (19 to 44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  60.0%      3  60.0%      6  60.0% 
Male      2  40.0%      2  40.0%      4  40.0% 
Region of Enrollment 
[Units: Participants]
     
United States   5   5   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   % Cyclic Amine Mono Phosphate (cAMP) Response Element Binding Protein (CBP) White Blood Cell (WBC) Phosphorylation (Metformin Treated vs no Treatment)   [ Time Frame: 10 weeks ]

2.  Secondary:   Change in BMI   [ Time Frame: Baseline and after about 30 days ]

3.  Secondary:   Fasting Blood Glucose.   [ Time Frame: 30 days ]

4.  Other Pre-specified:   Effect of Dose Escalation   [ Time Frame: Approximately Week 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sally Radovick
Organization: Johns Hopkins University
phone: 7322359524 ext 7733073353
e-mail: sradovick@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01876992     History of Changes
Other Study ID Numbers: NA_00046072
NA_00046072 ( Other Identifier: JohnHopkinsU )
First Submitted: May 2, 2013
First Posted: June 13, 2013
Results First Submitted: August 2, 2016
Results First Posted: August 28, 2017
Last Update Posted: September 26, 2017