Trial Outcomes & Findings for An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201) (NCT NCT01357135)

Last Updated: 2017-06-05

Results Overview

The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.

Recruitment status

COMPLETED

Target enrollment

3453 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2017-06-05

Participant Flow

This was an observational, non-randomized, prospective, longitudinal study of participants with Type 2 diabetes mellitus treated in routine clinical practice by 1,569 primary care practitioners in metropolitan France. Study participants were enrolled from July 29, 2009 to December 31, 2010. The end of study follow-up was August 31, 2013.

Participant milestones

Participant milestones
Measure	Metformin + Sitagliptin Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.	Metformin + Sulfonylurea Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.	Sitagliptin +/- Other Antihyperglycemic Medication Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
Overall Study STARTED	1874	733	846
Overall Study COMPLETED	1276	510	583
Overall Study NOT COMPLETED	598	223	263

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin + Sitagliptin n=1874 Participants Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.	Metformin + Sulfonylurea n=733 Participants Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.	Sitagliptin +/- Other Antihyperglycemic Medication n=846 Participants Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.	Total n=3453 Participants Total of all reporting groups
Age, Continuous	62.4 Years STANDARD_DEVIATION 10.8 • n=5 Participants	64.2 Years STANDARD_DEVIATION 11.5 • n=7 Participants	65.5 Years STANDARD_DEVIATION 11.3 • n=5 Participants	63.5 Years STANDARD_DEVIATION 11.2 • n=4 Participants
Sex/Gender, Customized Female	758 Participants n=5 Participants	311 Participants n=7 Participants	372 Participants n=5 Participants	1441 Participants n=4 Participants
Sex/Gender, Customized Male	1108 Participants n=5 Participants	422 Participants n=7 Participants	474 Participants n=5 Participants	2004 Participants n=4 Participants
Sex/Gender, Customized Missing	8 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.

Outcome measures

Outcome measures
Measure	Metformin + Sitagliptin n=1874 Participants Participants taking metformin + sitagliptin as prescribed in routine clinical practice.	Metformin + Sulfonylurea n=733 Participants Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
Median Duration (in Months) of Initial Dual Therapy	43.2 months Interval 41.4 to There were insufficient number of participants with events to estimate an upper confidence limit.	20.2 months Interval 17.0 to 25.1

PRIMARY outcome

Timeframe: Up to 3 years

Population: All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.

Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.

Outcome measures

Outcome measures
Measure	Metformin + Sitagliptin n=1874 Participants Participants taking metformin + sitagliptin as prescribed in routine clinical practice.	Metformin + Sulfonylurea n=733 Participants Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
Percentage of Participants With Strict Changes in Initial Dual Therapy	33.1 Percentage of Participants	46.5 Percentage of Participants

Adverse Events

Metformin + Sitagliptin

Serious events: 68 serious events

Other events: 0 other events

Deaths: 0 deaths

Metformin + Sulfonylurea

Serious events: 35 serious events

Other events: 0 other events

Deaths: 0 deaths

Sitagliptin +/- Other Antihyperglycemic Medication

Serious events: 66 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators cannot disclose any results without sponsor's agreement, only on request of French Health Authorities as per French law.
Publication restrictions are in place

Restriction type: OTHER