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

N

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

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

Trial contacts and locations

1

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Central trial contact

Namyi Gu, MD, PhD; Han Seok Choi, MD, PhD

Data sourced from clinicaltrials.gov

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