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Completed

NCT Number: NCT01645332

Efficacy and Safety of DLBS3233 in 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.

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Key information

Conditions

Type-2-diabetes Mellitus New Onset

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital

Semarang, Central Java, 50231, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo of DLBS3233

Drug

Placebo of DLBS3233 once daily for 12 weeks

Other names: Placebo of Inlacin

DLBS3233

Drug

100 mg DLBS3233 once daily for 12 weeks

Other names: Inlacin

lifestyle modification

Other

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.

Primary outcomes

  1. Reduction of A1c level

    Time frame: 12 weeks

    Reduction of A1c level from baseline to Week 12 of treatment

Secondary outcomes

  1. Reduction of venous FPG

    Time frame: 6 weeks and 12 weeks

    Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment

  2. Reduction of venous 2h-PG

    Time frame: 6 weeks and 12 weeks

    Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment

  3. Response rate

    Time frame: 12 weeks

    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

  4. Change in fasting insulin level

    Time frame: 12 weeks

    Change in fasting insulin level from baseline to Week 12 of treatment

  5. Change in HOMA-IR

    Time frame: 12 weeks

    Change in HOMA-IR from baseline to Week 12 of treatment

  6. Change in HOMA-B

    Time frame: 12 weeks

    Change in HOMA-B from baseline to Week 12 of treatment

  7. Change in adiponectin level

    Time frame: 12 weeks

    Change in adiponectin level from baseline to Week 12 of treatment

  8. Change in lipid profile

    Time frame: 12 weeks

    Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment

  9. Change in body weight

    Time frame: 6 weeks and 12 weeks

    Change in body weight from baseline to Week 6 and Week 12 of treatment

  10. Vital signs

    Time frame: 6 weeks and 12 weeks

    Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12

  11. Liver function

    Time frame: 12 weeks

    Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12

  12. Renal function

    Time frame: 12 weeks

    Renal function (serum creatinine level) will be evaluated at baseline and Week 12

  13. Electrocardiography (ECG)

    Time frame: 12 weeks

    ECG will be evaluated at baseline and Week 12

  14. Adverse events

    Time frame: 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Registry information

Official study title

Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2012
Registry last updated
Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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