NCT01645332

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

July 18, 2012

Last Update Submit

October 7, 2014

Conditions

Type-2-diabetes MellitusNew Onset

Keywords

DLBS3233new onsettype-2-diabetes mellitusoral anti-hyperglycemic agent

Outcome Measures

Primary Outcomes (1)

  • Reduction of A1c level

    Reduction of A1c level from baseline to Week 12 of treatment

    12 weeks

Secondary Outcomes (14)

  • Reduction of venous FPG

    6 weeks and 12 weeks

  • Reduction of venous 2h-PG

    6 weeks and 12 weeks

  • Response rate

    12 weeks

  • Change in fasting insulin level

    12 weeks

  • Change in HOMA-IR

    12 weeks

  • +9 more secondary outcomes

Study Arms (2)

Treatment I (control)

PLACEBO COMPARATOR

Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification

Drug: Placebo of DLBS3233Other: Lifestyle modification

Treatment II

EXPERIMENTAL

100 mg DLBS3233 once daily for 12 weeks + lifestyle modification

Drug: DLBS3233Other: Lifestyle modification

Interventions

Placebo of DLBS3233DRUG

Placebo of DLBS3233 once daily for 12 weeks

Also known as: Placebo of Inlacin
Treatment I (control)
DLBS3233DRUG

100 mg DLBS3233 once daily for 12 weeks

Also known as: Inlacin
Treatment II
Lifestyle modificationOTHER

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.

Treatment I (control)Treatment II

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Semarang, Central Java, 50231, Indonesia

Location

MeSH Terms

Interventions

DLBS3233

Study Officials

  • Heri Nugroho, Dr,dr,SpPD,KEMD,FINASIM

    Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

ID(1)