Type 2 Diabetes Mellitus
Conditions
Brief summary
This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes participants * De novo treatment (first prescription or dated within the past 8 weeks) with: * Metformin + sitagliptin dual therapy, * Metformin + sulfonylurea dual therapy, * Sitagliptin as part of another treatment regimen * Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Duration (in Months) of Initial Dual Therapy | Up to 3 years | 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. |
| Percentage of Participants With Strict Changes in Initial Dual Therapy | Up to 3 years | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Metformin + Sitagliptin Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice. | 1,874 |
| Metformin + Sulfonylurea Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride. | 733 |
| 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. | 846 |
| Total | 3,453 |
Baseline characteristics
| Characteristic | Metformin + Sitagliptin | Metformin + Sulfonylurea | Sitagliptin +/- Other Antihyperglycemic Medication | Total |
|---|---|---|---|---|
| Age, Continuous | 62.4 Years STANDARD_DEVIATION 10.8 | 64.2 Years STANDARD_DEVIATION 11.5 | 65.5 Years STANDARD_DEVIATION 11.3 | 63.5 Years STANDARD_DEVIATION 11.2 |
| Sex/Gender, Customized Female | 758 Participants | 311 Participants | 372 Participants | 1441 Participants |
| Sex/Gender, Customized Male | 1108 Participants | 422 Participants | 474 Participants | 2004 Participants |
| Sex/Gender, Customized Missing | 8 Participants | 0 Participants | 0 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,874 | 0 / 733 | 0 / 846 |
| serious Total, serious adverse events | 68 / 1,874 | 35 / 733 | 66 / 846 |
Outcome results
Primary
Median Duration (in Months) of Initial Dual Therapy
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.
Time frame: Up to 3 years
Population: All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Metformin + Sitagliptin | Median Duration (in Months) of Initial Dual Therapy | 43.2 months |
| Metformin + Sulfonylurea | Median Duration (in Months) of Initial Dual Therapy | 20.2 months |
Primary
Percentage of Participants With Strict Changes in Initial Dual Therapy
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.
Time frame: Up to 3 years
Population: All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metformin + Sitagliptin | Percentage of Participants With Strict Changes in Initial Dual Therapy | 33.1 Percentage of Participants |
| Metformin + Sulfonylurea | Percentage of Participants With Strict Changes in Initial Dual Therapy | 46.5 Percentage of Participants |