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Glycemic Variability of Combination Therapies in T2DM

ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorJW Pharmaceutical

About this trial

Glycemic Variability of Combination Therapies in T2DM

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin/Metformin

    Drug

    5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)

  • Anagliptin

    Drug

    100 mg, for 12 weeks (PO, BID)

  • Metformin

    Drug

    500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)

  • Empagliflozin/Linagliptin

    Drug

    10/5 mg, for 12 weeks (PO, QD)

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 2 interventions
Group B: Active ComparatorActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12

Time frame
Baseline to week 12

Secondary outcomes

1

Change in the percentage of time spent within the target glucose range (70-180 mg/dL)

Time frame
Baseline to week 12
2

Change from baseline in mean blood glucose at 12 weeks

Time frame
Baseline to week 12
3

Change from baseline in HbA1c at 12 weeks

Time frame
Baseline to week 12
4

Change from baseline in FPG at 12 weeks

Time frame
Baseline to week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JW Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov
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