Incretins in Impaired Fasting Glucose

This study has been completed.

Study NCT00364377 Information provided by Mayo Clinic

First Received on August 14, 2006. Last Updated on November 1, 2011 History of Changes

Results First Received: April 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Pre-diabetes
Interventions:	Drug: Sitagliptin Other: 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
Impaired Fasting Glucose (IFG) not on treatment with glucose-lowering medication

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
Sitagliptin	People with impaired fasting glucose treated with sitagliptin 100mg once daily.
Placebo	People with impaired fasting glucose treated with placebo once daily.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Sitagliptin	People with impaired fasting glucose treated with sitagliptin 100mg once daily.
Placebo	People with impaired fasting glucose treated with placebo once daily.

Baseline Measures

	Sitagliptin	Placebo	Total
Number of Participants [units: participants]	11	11	22
Age [units: years] Mean ± Standard Deviation	55.2 ± 2.5	54.1 ± 2.4	54.7 ± 1.8
Gender [units: participants]
Female	10	8	18
Male	1	3	4
Region of Enrollment [units: participants]
United States	11	11	22

Outcome Measures

1. Primary:

Lowering of Fasting Glucose [ Time Frame: 8 weeks ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

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

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.

Results Point of Contact:

Name/Title: Adrian Vella
Organization: Mayo Clinic
phone: 507-284-3754
e-mail: vella.adrian@mayo.edu

Publications of Results:

Responsible Party:	Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00364377 History of Changes
Other Study ID Numbers:	06-002673
Study First Received:	August 14, 2006
Results First Received:	April 4, 2011
Last Updated:	November 1, 2011
Health Authority:	United States: Food and Drug Administration