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A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes

ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Capable of understanding and voluntarily signing the written informed consent form.

Disqualifiers

1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cofrogliptin

    Drug

    10mg administered once every two weeks

  • Acarbose

    Drug

    50mg administered 3 times daily

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Cofrogliptin （HSK7653）Experimental treatment 1 intervention
Group B: AcarboseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

The difference in HbA1c from the baseline

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

FPG (Fasting plasma glucose)

The difference in FPG from the baseline

Time frame
From enrollment to the end of treatment at 12 weeks
2

2h-PPG (2-hour postprandial glucose)

The difference in 2h-PPG from the baseline

Time frame
From enrollment to the end of treatment at 12 weeks
3

Fasting C-peptide

The difference in fasting C-peptide from the baseline

Time frame
From enrollment to the end of treatment at 12 weeks
4

Insulin sensitivity

The difference in insulin sensitivity from the baseline

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

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

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: