Study of Sitagliptin in Older Type 2 Diabetics - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition:	Type 2 Diabetes
Interventions:	Drug: Comparator: sitagliptin phosphate Drug: Comparator: 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
First Patient In: 30-MAR-2006 Last Patient Last Visit: 12-MAR-2008 60 medical clinics in the United States.

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

First Patient In: 30-MAR-2006

Last Patient Last Visit: 12-MAR-2008

60 medical clinics in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Community dwelling patients ≥65 years of age with a diagnosis of type 2 diabetes with HbA1c ≥7% and ≤10% on diet and exercise were eligible to participate. Following a screening period of variable duration, patients were randomized in a 1:1 ratio to sitagliptin 100 mg q.d. (or 50 mg q.d. based on creatinine clearance) and placebo.

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

Community dwelling patients ≥65 years of age with a diagnosis of type 2 diabetes with HbA1c ≥7% and ≤10% on diet and exercise were eligible to participate. Following a screening period of variable duration, patients were randomized in a 1:1 ratio to sitagliptin 100 mg q.d. (or 50 mg q.d.

based on creatinine clearance) and placebo.

Reporting Groups

	Description
Sitagliptin	Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to <50 mL/min at any time during the study.
Placebo	Sitagliptin-matching placebo tablets.

Participant Flow: Overall Study

	Sitagliptin	Placebo
STARTED	102	104
COMPLETED	70	57
NOT COMPLETED	32	47
Adverse Event	6	3
Lack of Efficacy	11	18
Lost to Follow-up	0	4
Protocol Violation	2	1
Withdrawal by Subject	12	21
Patient moved	1	0

Baseline Characteristics

Reporting Groups

	Description
Sitagliptin	Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to <50 mL/min at any time during the study.
Placebo	Sitagliptin-matching placebo tablets.

Baseline Measures

	Sitagliptin	Placebo	Total
Number of Participants [units: participants]	102	104	206
Age [units: years] Mean ± Standard Deviation	71.6 ± 6.1	72.1 ± 6.0	71.9 ± 6.0
Gender [units: participants]
Female	54	55	109
Male	48	49	97
Race, Customized [units: participants]
White	76	86	162
Black	10	9	19
Hispanic	9	6	15
Asian	3	3	6
Other	4	0	4
HbA1c (Hemoglobin A1c) [units: Percent] Mean ± Standard Deviation	7.8 ± 0.8	7.8 ± 0.7	7.8 ± 0.7

Outcome Measures

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1. Primary Outcome Measure: Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24

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2. Secondary Outcome Measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24

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3. Secondary Outcome Measure: Change From Baseline in 2-Hour PPG (Post-Prandial Glucose) at Week 24

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4. Secondary Outcome Measure: Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week

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Reported Adverse Events

Reporting Groups

	Description
Sitagliptin	Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to <50 mL/min at any time during the study.
Placebo	Sitagliptin-matching placebo tablets.

Serious Adverse Events

	Sitagliptin	Placebo
Total, serious adverse events
number of participants affected	7	14
Cardiac disorders
Any Cardiac disorders number of participants at risk number of participants affected	102 1	104 4
Coronary Artery Disease number of participants at risk number of participants affected	102 1	104 3
Angina Pectoris number of participants at risk number of participants affected	102 0	104 1
Gastrointestinal disorders
Any Gastrointestinal disorders number of participants at risk number of participants affected	102 0	104 2
Gastroesophageal Reflux Disease number of participants at risk number of participants affected	102 0	104 1
Lower Gastrointestinal Hemorrhage number of participants at risk number of participants affected	102 0	104 1
Hepatobiliary disorders
Any Hepatobiliary disorders number of participants at risk number of participants affected	102 0	104 1
Cholecystitis number of participants at risk number of participants affected	102 0	104 1
Infections and infestations
Any Infections and infestations number of participants at risk number of participants affected	102 3	104 3
Bronchitis number of participants at risk number of participants affected	102 1	104 0
Diverticulitis number of participants at risk number of participants affected	102 0	104 1
Mycobacterium Avium Complex Infection number of participants at risk number of participants affected	102 0	104 1
Pneumonia number of participants at risk number of participants affected	102 1	104 1
Sinusitis number of participants at risk number of participants affected	102 1	104 0
Staphylococcal Sepsis number of participants at risk number of participants affected	102 1	104 0
Injury, poisoning and procedural complications
Any Injury, poisoning and procedural complications number of participants at risk number of participants affected	102 0	104 2
Lumbar Vertebral Fracture number of participants at risk number of participants affected	102 0	104 1
Upper Limb Fracture number of participants at risk number of participants affected	102 0	104 1
Metabolism and nutrition disorders
Any Metabolism and nutrition disorders number of participants at risk number of participants affected	102 0	104 1
Dehydration number of participants at risk number of participants affected	102 0	104 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Neoplasms benign, malignant and unspecified number of participants at risk number of participants affected	102 3	104 0
Basal Cell Carcinoma number of participants at risk number of participants affected	102 2	104 0
Colon Cancer number of participants at risk number of participants affected	102 1	104 0
Malignant Melanoma number of participants at risk number of participants affected	102 1	104 0
Squamous Cell Carcinoma Of Skin number of participants at risk number of participants affected	102 1	104 0
Renal and urinary disorders
Any Renal and urinary disorders number of participants at risk number of participants affected	102 0	104 2
Bladder Obstruction number of participants at risk number of participants affected	102 0	104 1
Renal Failure Acute number of participants at risk number of participants affected	102 0	104 1
Reproductive system and breast disorders
Any Reproductive system and breast disorders number of participants at risk number of participants affected	102 0	104 1
Pelvic Pain number of participants at risk number of participants affected	102 0	104 1
Respiratory, thoracic and mediastinal disorders
Any Respiratory, thoracic and mediastinal disorders number of participants at risk number of participants affected	102 0	104 1
Asthma number of participants at risk number of participants affected	102 0	104 1

Events were spontaneously reported.

Frequency Threshold for Reporting Other Adverse Events: ≥5%

Other Adverse Events

	Sitagliptin	Placebo
Total, other (not including serious) adverse events
number of participants affected	4	6
Infections and infestations
Any Infections and Infestations number of participants at risk number of participants affected	102 4	104 6
Urinary Tract Infection number of participants at risk number of participants affected	102 4	104 6

Events were spontaneously reported.

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
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Results Point of Contact:

Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_003, MK0431-047
Study First Received:	March 20, 2006
Results First Received:	February 24, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00305604 History of Changes
Health Authority:	United States: Food and Drug Administration