Type 2 Diabetes
Conditions
Brief summary
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
Interventions
DRUGSitagliptin phosphate
Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.
DRUGMetformin
Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Participants with T2DM failing metformin monotherapy * Between the ages of 18 and 79
Exclusion criteria
* Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment | 4 weeks | Safety & tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 4 | Baseline and Week 4 | Calculated as the mean change from baseline in fasting plasma glucose at Week 4. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Sitagliptin |
|---|---|
| Age, Customized <= 40 years | 5 Participants |
| Age, Customized 41 to 50 years | 8 Participants |
| Age, Customized 51 to 60 years | 7 Participants |
| Age, Customized >= 60 years | 10 Participants |
| Baseline Fasting Plasma Glucose | 8.9 mmol/L STANDARD_DEVIATION 1.5 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
Safety & tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitagliptin | Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment | At least one adverse event | 5 Participants |
| Sitagliptin | Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment | At least one drug-related adverse event | 5 Participants |
| Sitagliptin | Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment | At least one serious adverse event | 0 Participants |
| Sitagliptin | Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment | Discontinued treatment due to an adverse event | 0 Participants |
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 4
Calculated as the mean change from baseline in fasting plasma glucose at Week 4.
Time frame: Baseline and Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Change From Baseline in Fasting Plasma Glucose at Week 4 | 1.6 mmol/L | Standard Deviation 2.2 |