An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus - Study Results

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:	Diabetes Mellitus, Type 2
Interventions:	Drug: sitagliptin (MK0431) Drug: Comparator: glipizide

Participant Flow

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: 26-Oct-2004; Last Patient Last Visit: 17-May-2007; 173 medical clinics worldwide.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants 18-78 years of age with type 2 diabetes mellitus (T2DM) and inadequate glycemic control (Hemoglobin A1c >6.5% and < 10%) on metformin at a dose of >1500mg/day.

Reporting Groups

	Description
Sitagliptin 100 mg	The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
Glipizide	The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

Participant Flow for 2 periods

Period 1: Year 1 ( Week 0 to Week 52)

	Sitagliptin 100 mg	Glipizide
STARTED	588	584
COMPLETED	386 ^[1]	412 ^[2]
NOT COMPLETED	202	172
Adverse Event	25	26
Lack of Efficacy	86	58
Lost to Follow-up	19	10
Protocol Violation	10	10
Protocol Specified Discontinuation	19	25
Patient Moved	6	2
Withdrawal by Subject	25	28
Site Terminated	2	2
Unspecified	10	11

[1]	4 Participants who Completed Week 52, Did NOT Enter second year
[2]	11 Participants who Completed Week 52, Did NOT Enter second year

Period 2: Year 2 (Week 0 to Week 104)

	Sitagliptin 100 mg	Glipizide
STARTED	588	584
COMPLETED	255	264
NOT COMPLETED	333	320
Adverse Event	35	36
Lack of Efficacy	180	162
Lost to Follow-up	25	15
Protocol Violation	13	12
Protocol Specified Discontinuation	29	30
Patient Moved	6	2
Withdrawal by Subject	28	38
Site Terminated	2	2
Unspecified	15	23

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin 100 mg	The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
Glipizide	The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

Baseline Measures

	Sitagliptin 100 mg	Glipizide	Total
Number of Participants [units: participants]	588	584	1172
Age [units: years] Mean ± Standard Deviation	56.8 ± 9.3	56.6 ± 9.8	56.7 ± 9.55
Gender [units: participants]
Female	252	226	478
Male	336	358	694
Race/Ethnicity, Customized [units: participants]
Asian	50	49	99
Black	41	35	76
Hispanic	43	46	89
White	432	434	866
Other	22	20	42
Hemoglobin A1c (HbA1c) [units: Percent] Mean ± Standard Deviation	7.7 ± 0.9	7.6 ± 0.9	7.7 ± 0.9

Outcome Measures

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1. Primary:

Change From Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ]

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2. Secondary:

Change From Baseline in HbA1c at Week 104 [ Time Frame: Baseline and Week 104 ]

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3. Secondary:

Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline and Week 52 ]

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4. Secondary:

Change From Baseline in Body Weight at Week 104 [ Time Frame: Baseline and Week 104 ]

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5. Secondary:

Hypoglycemic Events at Week 52 [ Time Frame: Baseline to Week 52 ]

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6. Secondary:

Hypoglycemic Events at Week 104 [ Time Frame: Baseline to Week 104 ]

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7. Secondary:

Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 [ Time Frame: Baseline to Week 104 ]

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8. Secondary:

Number of Participants With Serious CAEs at Week 104 [ Time Frame: Baseline to Week 104 ]

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9. Secondary:

Number of Participants With Drug-related CAEs at Week 104 [ Time Frame: Baseline to Week 104 ]

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10. Secondary:

Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 [ Time Frame: Baseline to Week 104 ]

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11. Secondary:

Number of Participants With Serious LAEs at Week 104 [ Time Frame: Baseline to Week 104 ]

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12. Secondary:

Number of Participants With Drug-related LAEs at Week 104 [ Time Frame: Baseline to Week 104 ]

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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

Publications:

Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205.

Publications automatically indexed to this study:

Seck TL, Engel SS, Williams-Herman DE, Sisk CM, Golm GT, Wang H, Kaufman KD, Goldstein BJ. Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide. Diabetes Res Clin Pract. 2011 Jul;93(1):e15-7. Epub 2011 Apr 8.

Seck T, Nauck M, Sheng D, Sunga S, Davies MJ, Stein PP, Kaufman KD, Amatruda JM; Sitagliptin Study 024 Group. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010 Apr;64(5):562-76.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00094770 History of Changes
Other Study ID Numbers:	2004_049, MK0431-024
Study First Received:	October 22, 2004
Results First Received:	September 24, 2009
Last Updated:	April 7, 2010
Health Authority:	United States: Food and Drug Administration