NCT01472614

Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus

Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.

Detailed description

There will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100 mg once daily for 12 weeks. Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.

Conditions

• Type-2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DLBS3233	Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2011-11-16
• Last updated: 2013-05-27

Locations

2 sites across 1 country: Indonesia