Initial Combination With Pioglitazone Study

This study has been completed.

Study NCT00397631 Information provided by Merck

First Received on November 8, 2006. Last Updated on April 20, 2010 History of Changes

Results First Received: May 19, 2009

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
Interventions:	Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.

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: 01-Feb-2007; Last Patient Last Visit: 28-Jun-2008; 60 study sites worldwide.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients ≥18 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (HbA1C ≥8% and ≤12%) on diet and exercise alone were eligible for randomization.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patients ≥18 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (HbA1C

≥8% and ≤12%) on diet and exercise alone were eligible for randomization.

Reporting Groups

	Description
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.	The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
Pioglitazone 30 mg q.d.	The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.

Participant Flow: Overall Study

	Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.	Pioglitazone 30 mg q.d.
STARTED	261 ^[1]	259
COMPLETED	231	215
NOT COMPLETED	30	44
Adverse Event	5	6
Lack of Efficacy	7	10
Lost to Follow-up	8	9
Physician Decision	2	0
Protocol Violation	0	1
Withdrawal by Subject	7	14
protocol discontinuation criteria	1	4

[1]	Randomization ratio was 1:1

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.	The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
Pioglitazone 30 mg q.d.	The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.

Baseline Measures

	Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.	Pioglitazone 30 mg q.d.	Total
Number of Participants [units: participants]	261	259	520
Age [units: years] Mean ± Standard Deviation	50.2 ± 10.2	51.6 ± 11.2	50.9 ± 10.7
Gender [units: participants]
Female	124	114	238
Male	137	145	282
Race/Ethnicity, Customized [units: participants]
White	138	134	272
Black	11	8	19
Asian	85	83	168
Other	27	34	61
HbA1c (Hemoglobin A1C) [units: Percent] Mean ± Standard Deviation	9.5 ± 1.2	9.5 ± 1.2	9.5 ± 1.2

Outcome Measures

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1. Primary:

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: Baseline and 24 weeks ]

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2. Secondary:

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ]

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3. Secondary:

Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ]

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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:	NCT00397631 History of Changes
Other Study ID Numbers:	2006_531, MK0431-064
Study First Received:	November 8, 2006
Results First Received:	May 19, 2009
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration