Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus

This study has been completed.

Study NCT00511108 Information provided by Merck

First Received on August 2, 2007. Last Updated on April 20, 2010 History of Changes

Results First Received: January 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus (T2DM)
Interventions:	Drug: Comparator: sitagliptin phosphate Drug: Comparator: pioglitazone Drug: Comparator: placebo to pioglitazone Drug: Comparator: placebo to sitagliptin

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
First Patient In: 12-Sep-2007; Last Patient Last Visit: 24-Feb-2009 Forty-four medical clinics worldwide (17 in the United States, 20 in Europe, 4 in Australia, and 3 in Israel).

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

First Patient In: 12-Sep-2007; Last Patient Last Visit: 24-Feb-2009

Forty-four medical clinics worldwide (17 in the United States, 20 in Europe, 4 in Australia, and 3 in Israel).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 30-65 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (fasting plasma glucose [FPG] 130-260 mg/dL [7.2-14.4 mmol/L]) on diet and exercise alone were eligible for randomization.

Reporting Groups

	Description
Sitagliptin 100 mg	Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
Pioglitazone 30 mg	Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
Sitagliptin 100 mg + Pioglitazone 30 mg	Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
Placebo	Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.

Participant Flow: Overall Study

	Sitagliptin 100 mg	Pioglitazone 30 mg	Sitagliptin 100 mg + Pioglitazone 30 mg	Placebo
STARTED	52	54	52	53
COMPLETED	46	52	47	48
NOT COMPLETED	6	2	5	5
Adverse Event	2	0	1	2
Lost to Follow-up	0	2	1	0
Physician Decision	0	0	0	1
Withdrawal by Subject	4	0	3	2

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin 100 mg	Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
Pioglitazone 30 mg	Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
Sitagliptin 100 mg + Pioglitazone 30 mg	Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
Placebo	Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.

Baseline Measures

	Sitagliptin 100 mg	Pioglitazone 30 mg	Sitagliptin 100 mg + Pioglitazone 30 mg	Placebo	Total
Number of Participants [units: participants]	52	54	52	53	211
Age [units: years] Mean ± Standard Deviation	54.6 ± 7.6	53.4 ± 7.8	53.3 ± 8.6	53.3 ± 7.7	53.6 ± 7.9
Gender [units: participants]
Female	24	31	18	21	94
Male	28	23	34	32	117
Race/Ethnicity, Customized [units: participants]
White	45	43	49	48	185
Black	6	9	3	2	20
Asian	1	1	0	2	4
Other	0	1	0	1	2
Glucose 5-hour (hr) Total area under the curve (AUC) ^[1] [units: mg*hr/dL] Mean ± Standard Deviation	1179.9 ± 322.8	1250.6 ± 349.6	1276.0 ± 348.5	1255.1 ± 290.9	1240.4 ± 328.4
Hemoglobin A1c (HbA1c) [units: Percent] Mean ± Standard Deviation	7.7 ± 0.8	7.9 ± 0.9	7.9 ± 0.9	8.0 ± 1.1	7.9 ± 1.0

[1]	Glucose concentration was measured at 11 points during a Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The number of participants for the "Sitagliptin 100 mg + Pioglitazone 30 mg" arm is 51, making the total number of participants for this measure 210.

[1]

Glucose concentration was measured at 11 points during a Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method.

The number of participants for the "Sitagliptin 100 mg + Pioglitazone 30 mg" arm is 51, making the total number of participants for this measure 210.

Outcome Measures

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1. Primary:

Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]

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2. Primary:

Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]

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3. Secondary:

Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00511108 History of Changes
Other Study ID Numbers:	2007_530, MK0431-061
Study First Received:	August 2, 2007
Results First Received:	January 8, 2010
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration