Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Glycemic variability
Brief summary
Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.
Interventions
DRUGVildagliptin
Vildagliptin 50 mg twice daily
DRUGGlimepiride
Glimepiride 1-6 mg once daily
DRUGMetformin
Metformin (1000-1500 mg daily)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have given written informed consent to participate in the study. 2. Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive). 3. Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c \> 7.5 - 9%). 4. Patients with HbA1C levels within the range \> 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).
Exclusion criteria
1. Age \> 75 years ; BMI \<22 or \>40 kg/m2 2. Patients who are on Insulin therapy at the time of study entry. 3. Type 1 Diabetes Mellitus patients. 4. Patients with severe renal (creatinine clearance \< 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST \> 3 x ULN). Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976) 5. Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin. Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Amplitude of Glycemic Excursions (MAGE) | 16 weeks |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A: Vildagliptin Plus Metformin Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). | 48 |
| Group B: Glimepiride Plus Metformin Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). | 47 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Sponsor decision | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group A: Vildagliptin Plus Metformin | Group B: Glimepiride Plus Metformin | Total |
|---|---|---|---|
| Age, Continuous | 49.7 Years STANDARD_DEVIATION 11.86 | 52.1 Years STANDARD_DEVIATION 9.29 | 50.9 Years STANDARD_DEVIATION 10.68 |
| Sex: Female, Male Female | 22 Participants | 14 Participants | 36 Participants |
| Sex: Female, Male Male | 26 Participants | 33 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 48 | 1 / 47 |
| serious Total, serious adverse events | 0 / 48 | 1 / 47 |
Outcome results
Primary
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: 16 weeks
Population: The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed.