Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Brief summary
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy
Interventions
DRUGsitagliptin phosphate
sitagliptin 100 mg Once a day (QD) for 24 weeks
metformin 850 mg Twice a day (BID) for 24 weeks
DRUGComparator: Antidiabetic Standard of Care
Patient can take any oral antidiabetic drug (other than metformin)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Patient Has Type 2 Diabetes Mellitus * Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent * Patient Is Currently On Metformin Therapy (1500 Mg/Day) * Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With \>2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication * Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent * Patient Has An A1c of 6.5 % - 11.0%
Exclusion criteria
* Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24 | Baseline and 24 weeks | Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values. |
Participant flow
Recruitment details
Patients were recruited in Principal Investigator's private practice, in Mexico City. First Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008
Pre-assignment details
Patients 30 to 78 years of age with inadequate glycemic control (Glycosylated hemoglobin A1C (A1C) 6.5 to 11%) on diet/exercise and metformin dosed at ≥1500 mg per day patients were to receive either sitagliptin added to ongoing metformin or standard care added to ongoing metformin.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin + Metformin Patients administered sitagliptin and metformin | 36 |
| Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care. | 23 |
| Metformin Alone Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care. | 9 |
| Total | 68 |
Baseline characteristics
| Characteristic | Sitagliptin + Metformin | Metformin + Any Non-DPP-4i Oral Antidiabetic Drug | Metformin Alone | Total |
|---|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 9.8 | 56.0 years STANDARD_DEVIATION 8.5 | 53.3 years STANDARD_DEVIATION 11.7 | 54.69 years STANDARD_DEVIATION 9.55 |
| Body Mass Index (BMI) | 29.0 kg/m2 STANDARD_DEVIATION 4.5 | 28.8 kg/m2 STANDARD_DEVIATION 5.1 | 28.3 kg/m2 STANDARD_DEVIATION 5.2 | 28.84 kg/m2 STANDARD_DEVIATION 4.74 |
| Glycosylated Hemoglobin A1C (A1C) | 8.8 Percent STANDARD_DEVIATION 1.5 | 8.0 Percent STANDARD_DEVIATION 1.8 | 8.2 Percent STANDARD_DEVIATION 1.1 | 8.47 Percent STANDARD_DEVIATION 1.61 |
| Sex: Female, Male Female | 25 Participants | 19 Participants | 6 Participants | 50 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 3 Participants | 18 Participants |
| Time since diagnosis of diabetes | 8.9 Years STANDARD_DEVIATION 7.1 | 6.8 Years STANDARD_DEVIATION 8.5 | 10.9 Years STANDARD_DEVIATION 7.7 | 8.43 Years STANDARD_DEVIATION 7.68 |
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 / 36 | 1 / 23 | 0 / 9 |
| serious Total, serious adverse events | 0 / 36 | 0 / 23 | 0 / 9 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values.
Time frame: Baseline and 24 weeks
Population: Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.