A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00701090

First received: June 17, 2008

Last updated: December 17, 2010

Last verified: December 2010

History of Changes

Results First Received: September 13, 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
Conditions:	Type 2 Diabetes Mellitus, Non Insulin Dependent. Diabetes Mellitus, Non-Insulin-Dependent
Interventions:	Drug: sitagliptin Drug: Comparator: glimepiride Drug: open-label metformin

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
Phase III First Patient In: 14-May-2008; Last Patient Last Visit: 27-Oct-2009; 109 study centers worldwide

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients at least 18 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥6.5 and ≤9.0%) on a stable dose of metformin (at a dose of at least 1500 mg per day for at least 12 weeks) were eligible to enter the 30 week study. Up to a 2 week screening period, followed by a 2-week placebo run-in.

Reporting Groups

	Description
Sitagliptin	The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Glimepiride	The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).

Participant Flow: Overall Study

	Sitagliptin	Glimepiride
STARTED	516	519
COMPLETED	468	468
NOT COMPLETED	48	51
Adverse Event	11	2
Death	0	1
Lack of Efficacy	5	4
Lost to Follow-up	9	9
Physician Decision	3	4
Protocol Violation	2	3
Withdrawal by Subject	11	16
Other	7	12

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin	The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Glimepiride	The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Total	Total of all reporting groups

Baseline Measures

	Sitagliptin	Glimepiride	Total
Number of Participants [units: participants]	516	519	1035
Age [units: years] Mean ± Standard Deviation	56.3 ± 9.7	56.2 ± 10.1	56.3 ± 9.9
Gender [units: participants]
Female	232	240	472
Male	284	279	563
Race/Ethnicity, Customized [units: participants]
White	297	298	595
Black	6	6	12
Asian	109	111	220
American Indian/Alaska Native	25	26	51
Other	79	78	157
A1C (Hemoglobin A1c) [units: Percent] Mean ± Standard Deviation	7.50 ± 0.70	7.51 ± 0.76	7.50 ± 0.73

Outcome Measures

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1. Primary:

Change From Baseline in HbA1c at Week 30 [ Time Frame: Week 0 to Week 30 ]

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2. Secondary:

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 [ Time Frame: Week 0 to Week 30 ]

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3. Secondary:

Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 [ Time Frame: Week 0 to Week 30 ]

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4. Secondary:

Change From Baseline in Body Weight at Week 30 [ Time Frame: Week 0 to Week 30 ]

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5. Secondary:

Percent of Patients With A1C <7.0% at Week 30 [ Time Frame: Week 30 ]

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6. Secondary:

Percent of Patients With A1C <6.5% at Week 30 [ Time Frame: Week 30 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	Particpants analyzed are those who received at least 1 dose of study medication. One participant in the Glimepiride group did not receive any study medication and is not included in the analysis.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Sitagliptin	The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Glimepiride	The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).

Other Adverse Events

	Sitagliptin	Glimepiride
Total, other (not including serious) adverse events
# participants affected / at risk	58/519	134/518
Infections and infestations
Nasopharyngitis ^{* 1}
# participants affected / at risk	25/519 (4.82%)	36/518 (6.95%)
Metabolism and nutrition disorders
Hypoglycaemia ^{* 1}
# participants affected / at risk	36/519 (6.94%)	114/518 (22.01%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (12.1)

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
No text entered.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00701090 History of Changes
Other Study ID Numbers:	MK-0431-803, 2008_503
Study First Received:	June 17, 2008
Results First Received:	September 13, 2010
Last Updated:	December 17, 2010
Health Authority:	Austria: Federal Ministry for Health and Women

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