The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01120873
• Date of registration: 05/05/2010
• Prospective Registration: No
• Primary sponsor: Taichung Veterans General Hospital
• Public title: The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome
• Scientific title: Phase 3 Study of 3D in Metabolic Syndrome
• Date of first enrolment: March 2007
• Target sample size: 110
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01120873
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: I Te Lee, MD
• Affiliation: Taichung Veterans General Hospital, Taichung

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age between 30 and 75 years

- Fasting plasma glucose >= 100 mg/dl

- Triglyceride >= 150 mg/dl

- one of the criteria following

1. HDL <40 mg/dl in man or <50 mg/dl in woman

2. Blood pressure >= 135/85 mmHg or anti-hypertension drug treatment

3. Waist >90cm in man or 80cm in woman

- Signed the inform consent

Exclusion Criteria:

- Fasting plasma glucose > 180mg/dl

- Treated by more than two types oral hypoglycemic agents in past 3 months

- Treated continuously by anti-lipid agents for 3 months in past 6 months

- Treated by thiazolidinedione or digitalis at present

- Serum creatine > 2.5mg/dl

- Liver function (GOT or GPT) more than 3-fold upper limit

- Severe systemic disease by investigator's judgement

- Pregnant or nursing women

- Enrolled in other clinical study in recent 1 month



Age minimum: 30 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Intervention(s)

Drug: Metamin 3D

Primary Outcome(s)

Total cholesterol [Time Frame: 12 weeks]

Secondary Outcome(s)

Fasting plasma glucose [Time Frame: 12 weeks]

Fasting plasma glucose [Time Frame: 4 and 8 weeks]

The plasma glucose by meal tolerant test [Time Frame: 12 weeks]

Total cholesterol [Time Frame: 4 and 8 weeks]

Alanine aminotransferase [Time Frame: 12 weeks]

Low-density lipoprotein cholesterol [Time Frame: 4, 8 and 12 weeks]

Glycosylated hemoglobin [Time Frame: 12 weeks]

Glycosylated hemoglobin [Time Frame: 4 and 8 weeks]

Aspartate aminotransferase [Time Frame: 12 weeks]

The plasma insulin by meal tolerant test [Time Frame: 4 and 8 weeks]

Triglycerides [Time Frame: 4 and 8 weeks]

Systolic and diastolic blood pressure [Time Frame: 4, 8 and 12 weeks]

Creatinine [Time Frame: 12 weeks]

Triglycerides [Time Frame: 12 weeks]

Secondary ID(s)

S06203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors