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Incretins in Impaired Fasting Glucose

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ClinicalTrials.gov Identifier: NCT00364377
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : December 6, 2011
Last Update Posted : December 6, 2011
Sponsor:
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pre-diabetes
Interventions Drug: Sitagliptin
Other: Placebo
Enrollment 22
Recruitment Details Impaired Fasting Glucose (IFG) not on treatment with glucose-lowering medication
Pre-assignment Details  
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description People with impaired fasting glucose treated with sitagliptin 100mg once daily. People with impaired fasting glucose treated with placebo once daily.
Period Title: Overall Study
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Sitagliptin Placebo Total
Hide Arm/Group Description People with impaired fasting glucose treated with sitagliptin 100mg once daily. People with impaired fasting glucose treated with placebo once daily. Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
55.2  (2.5) 54.1  (2.4) 54.7  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
10
  90.9%
8
  72.7%
18
  81.8%
Male
1
   9.1%
3
  27.3%
4
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Lowering of Fasting Glucose
Hide Description fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol - all participants completed the intervention
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
People with impaired fasting glucose treated with sitagliptin 100mg once daily.
People with impaired fasting glucose treated with placebo once daily.
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: mmol/l
5.78  (0.12) 5.83  (0.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin, Placebo
Comments Paired comparisons (within groups) to examine differences between the baseline study and after 8-weeks of treatment were made using Student's two-tailed t-test for paired samples. Between-group comparisons were made using Student's two-tailed t-test for unpaired samples. Given the previously observed variation in fasting glucose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Twelve weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description People with impaired fasting glucose treated with sitagliptin 100mg once daily. People with impaired fasting glucose treated with placebo once daily.
All-Cause Mortality
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Sitagliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sitagliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)    
Skin and subcutaneous tissue disorders     
Rash   0/11 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adrian Vella
Organization: Mayo Clinic
Phone: 507-284-3754
EMail: vella.adrian@mayo.edu
Layout table for additonal information
Responsible Party: Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00364377    
Other Study ID Numbers: 06-002673
First Submitted: August 14, 2006
First Posted: August 15, 2006
Results First Submitted: April 4, 2011
Results First Posted: December 6, 2011
Last Update Posted: December 6, 2011