Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Glycemic Variability
Brief summary
Glycemic Variability of Combination Therapies in T2DM
Detailed description
A multicenter study to evaluate efficacy and safety
Interventions
5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
DRUGAnagliptin
100 mg, for 12 weeks (PO, BID)
DRUGMetformin
500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
10/5 mg, for 12 weeks (PO, QD)
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, open-label, active-controlled, parallel, phase IV
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor.
Exclusion criteria
* History of acute or chronic metabolic acidosis * Moderate to severe renal impairment (eGFR \< 45 mL/min/1.73m²) * Severe hepatic impairment * History of heart failure (NYHA Class III/IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12 | Baseline to week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the percentage of time spent within the target glucose range (70-180 mg/dL) | Baseline to week 12 | — |
| Change from baseline in mean blood glucose at 12 weeks | Baseline to week 12 | — |
| Change from baseline in HbA1c at 12 weeks | Baseline to week 12 | — |
| Change from baseline in FPG at 12 weeks | Baseline to week 12 | — |
| Change from baseline in HOMA-β at 12 weeks | Baseline to week 12 | HOMA- β: 20\*fasting insulin/\[(fasting plasma glucose\*0.0555)-3.5\] |
| Change from baseline in HOMA-IR at 12 weeks | Baseline to week 12 | HOMA-IR: fasting insulin\*(fasting glucose\*0.0555)/22.5 |
Countries
South Korea
Contacts
CONTACTSaemi Kang
PRINCIPAL_INVESTIGATORSung Rae Kim
The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator
Outcome results
None listed