Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01645332
First received: July 18, 2012
Last updated: October 7, 2014
Last verified: October 2014

July 18, 2012
October 7, 2014
July 2012
August 2014   (final data collection date for primary outcome measure)
Reduction of A1c level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reduction of A1c level from baseline to Week 12 of treatment
Same as current
Complete list of historical versions of study NCT01645332 on ClinicalTrials.gov Archive Site
  • Reduction of venous FPG [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment
  • Reduction of venous 2h-PG [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment
  • Response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with FPG < 110 mg/dL and/or reduction of at least 10% in FPG level from baseline to Week 12 of treatment
  • Change in fasting insulin level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in fasting insulin level from baseline to Week 12 of treatment
  • Change in HOMA-IR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in HOMA-IR from baseline to Week 12 of treatment
  • Change in HOMA-B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in HOMA-B from baseline to Week 12 of treatment
  • Change in adiponectin level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in adiponectin level from baseline to Week 12 of treatment
  • Change in lipid profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment
  • Change in body weight [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline to Week 6 and Week 12 of treatment
  • Vital signs [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: Yes ]
    Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12
  • Liver function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12
  • Renal function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Renal function (serum creatinine level) will be evaluated at baseline and Week 12
  • Electrocardiography (ECG) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    ECG will be evaluated at baseline and Week 12
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse events as well as number of subjects experienced the events will be observed and evaluated throughout study period (12 weeks) and until all adverse events have been recovered or stabilized
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus
Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy.

Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type-2-diabetes Mellitus
  • New Onset
  • Drug: Placebo of DLBS3233
    Placebo of DLBS3233 once daily for 12 weeks
    Other Name: Placebo of Inlacin
  • Drug: DLBS3233
    100 mg DLBS3233 once daily for 12 weeks
    Other Name: Inlacin
  • Other: Lifestyle modification
    Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
    Other Name: Lifestyle modification
  • Placebo Comparator: Treatment I (control)
    Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification
    Interventions:
    • Drug: Placebo of DLBS3233
    • Other: Lifestyle modification
  • Experimental: Treatment II
    100 mg DLBS3233 once daily for 12 weeks + lifestyle modification
    Interventions:
    • Drug: DLBS3233
    • Other: Lifestyle modification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
September 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects with age of 18-60 years
  • BMI ≥ 18.5 kg/m2
  • Newly diagnosed (new onset of) type 2 DM subjects, defined as FPG level of ≥ 126 mg/dL or 2h-PG level of ≥ 200 mg/dL or A1c of ≥ 6.5%)
  • FPG ≤ 183 mg/dL
  • Hemoglobin level of ≥ 10.0 g/dL
  • Serum ALT ≤ 2.5 times upper limit of normal
  • Serum creatinine < 1.5 times upper limit of normal

Exclusion Criteria:

  • Female of childbearing potential
  • Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
  • Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
  • History of renal and/or liver disease
  • History of or the presence of any clinical evidence of malignancies
  • Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
  • Current treatment with systemic corticosteroids or herbal (alternative) medicines
  • Participation in any other intervention trial within 30 days prior to Screening
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01645332
DLBS3233-0912
No
Dexa Medica Group
Dexa Medica Group
Not Provided
Principal Investigator: Heri Nugroho, Dr,dr,SpPD,KEMD,FINASIM Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia
Dexa Medica Group
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP