Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takeda Global Research & Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT00755846

First received: September 17, 2008

Last updated: February 1, 2012

Last verified: February 2012

History of Changes

Results First Received: June 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Diabetes Mellitus
Interventions:	Drug: Alogliptin Drug: Placebo

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
Participants enrolled at 62 sites in Chile and the United States from 17 March 2005 to 10 June 2005.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of type 2 diabetes mellitus who were either receiving no current treatment or currently treated with diet and exercise, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin enrolled in once daily (QD) groups.

Reporting Groups

	Description
Placebo QD	Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg QD	Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg QD	Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg QD	Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.

Participant Flow: Overall Study

	Placebo QD	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Alogliptin 100 mg QD
STARTED	43	44	44	45	44	45
COMPLETED	18	27	32	32	27	31
NOT COMPLETED	25	17	12	13	17	14
Adverse Event	0	0	0	1	3	2
Protocol Violation	1	1	1	1	1	1
Lost to Follow-up	0	2	1	0	4	2
Withdrawal by Subject	2	3	5	2	0	1
Hyperglycemic Rescue	21	7	5	8	8	7
Physician Decision	1	3	0	1	0	1
Administrative Error	0	1	0	0	0	0
Participant Non-compliance	0	0	0	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo QD	Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg QD	Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg QD	Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg QD	Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo QD	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Alogliptin 100 mg QD	Total
Number of Participants [units: participants]	43	44	44	45	44	45	265
Age, Customized [units: participants]
<65 years	33	38	33	36	31	34	205
≥65 years	10	6	11	9	13	11	60
Gender [units: participants]
Female	24	25	22	17	26	25	139
Male	19	19	22	28	18	20	126

Outcome Measures

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1. Primary:

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. [ Time Frame: Baseline and Day 85. ]

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2. Secondary:

Change From Baseline in Glycosylated Hemoglobin at Day 43. [ Time Frame: Baseline and Day 43. ]

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3. Secondary:

Change From Baseline in Fasting Plasma Glucose (Day 43). [ Time Frame: Baseline and Day 43 ]

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4. Secondary:

Change From Baseline in Fasting Plasma Glucose (Day 85). [ Time Frame: Baseline and Day 85. ]

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5. Secondary:

Change From Baseline in Fasting Fructosamine (Day 43). [ Time Frame: Baseline and Day 43. ]

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6. Secondary:

Change From Baseline in Fasting Fructosamine (Day 85). [ Time Frame: Baseline and Day 85. ]

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7. Secondary:

Change From Baseline in Total Cholesterol (Day 43). [ Time Frame: Baseline and Day 43 ]

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8. Secondary:

Change From Baseline in Total Cholesterol (Day 85). [ Time Frame: Baseline and Day 85. ]

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9. Secondary:

Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). [ Time Frame: Baseline and Day 43. ]

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10. Secondary:

Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). [ Time Frame: Baseline and Day 85. ]

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11. Secondary:

Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). [ Time Frame: Baseline and Day 43. ]

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12. Secondary:

Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). [ Time Frame: Baseline and Day 85. ]

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13. Secondary:

Change From Baseline in Triglycerides (Day 43). [ Time Frame: Baseline and Day 43. ]

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14. Secondary:

Change From Baseline in Triglycerides (Day 85). [ Time Frame: Baseline and Day 85. ]

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15. Secondary:

Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). [ Time Frame: 85 Days. ]

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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: No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.

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: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com

Publications of Results:

Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. Epub 2009 Sep 30.

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00755846 History of Changes
Other Study ID Numbers:	SYR-322-003, U1111-1113-8352
Study First Received:	September 17, 2008
Results First Received:	June 8, 2011
Last Updated:	February 1, 2012
Health Authority:	United States: Food and Drug Administration

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