Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients

Namyi Gu

Status and phase: Unknown; Early Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Combination of Metformin + S. Baicalensis; Drug: Combination of Metformin + Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02844803

S.baicalensis-Metformin

Details and patient eligibility

About

The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as a diabetes mellitus patient at least 3 months ago on screening
• Treated with metformin of ≥ 500 mg/day over 3 months on screening
• Fasting glucose level of 110~180 mg/dl or HbA1c of 7.0~9.0% on screening

Exclusion criteria

• With acute or chronic inflammation
• Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication
• With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases
• With acute or chronic renal failure or nephrotic syndrome
• With impaired hepatic function.
• Drug or Alcoholic abuser
• Pregnant or nursing woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Active drug-> Placebo

Other group

Description:

Metformin + S. Baicalensis --\> Metformin + Placebo

Treatment:

Drug: Combination of Metformin + Placebo

Drug: Combination of Metformin + S. Baicalensis

Placebo -> Active drug

Other group

Description:

Metformin + Placebo --\> Metformin + S. Baicalensis

Treatment:

Drug: Combination of Metformin + Placebo

Drug: Combination of Metformin + S. Baicalensis