Incretins in Impaired Fasting Glucose

• 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: Mayo Clinic
• 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

Participant Flow

Recruitment Details	Impaired Fasting Glucose (IFG) not on treatment with glucose-lowering medication
Pre-assignment Details

Arm/Group Title	Sitagliptin	Placebo
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

Baseline Characteristics

Arm/Group Title		Sitagliptin	Placebo	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Lowering of Fasting Glucose
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

Outcome Measure Data

Analysis Population Description

Analysis was per protocol - all participants completed the intervention

Arm/Group Title	Sitagliptin	Placebo
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)

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]

Adverse Events

Time Frame	Twelve weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Sitagliptin		Placebo
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	--/--		--/--
Serious Adverse Events
	Sitagliptin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0.00%)		0/11 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Adrian Vella
• Organization: Mayo Clinic
• Phone: 507-284-3754
• EMail: vella.adrian@mayo.edu

Publications of Results:

Bock G, Dalla Man C, Micheletto F, Basu R, Giesler PD, Laugen J, Deacon CF, Holst JJ, Toffolo G, Cobelli C, Rizza RA, Vella A. The effect of DPP-4 inhibition with sitagliptin on incretin secretion and on fasting and postprandial glucose turnover in subjects with impaired fasting glucose. Clin Endocrinol (Oxf). 2010 Aug;73(2):189-96. doi: 10.1111/j.1365-2265.2009.03764.x. Epub 2009 Dec 18.

• 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