Back to resultsEfficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus
Primary Purpose
Type-2-diabetes Mellitus, New Onset
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Placebo of DLBS3233
DLBS3233
Lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for Type-2-diabetes Mellitus focused on measuring DLBS3233, new onset, type-2-diabetes mellitus, oral anti-hyperglycemic agent
Eligibility Criteria
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
Sites / Locations
- Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Treatment I (control)
Treatment II
Arm Description
Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification
100 mg DLBS3233 once daily for 12 weeks + lifestyle modification
Outcomes
Primary Outcome Measures
Reduction of A1c level
Reduction of A1c level from baseline to Week 12 of treatment
Secondary Outcome Measures
Reduction of venous FPG
Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment
Reduction of venous 2h-PG
Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment
Response rate
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
Change in fasting insulin level from baseline to Week 12 of treatment
Change in HOMA-IR
Change in HOMA-IR from baseline to Week 12 of treatment
Change in HOMA-B
Change in HOMA-B from baseline to Week 12 of treatment
Change in adiponectin level
Change in adiponectin level from baseline to Week 12 of treatment
Change in lipid profile
Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment
Change in body weight
Change in body weight from baseline to Week 6 and Week 12 of treatment
Vital signs
Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12
Liver function
Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12
Renal function
Renal function (serum creatinine level) will be evaluated at baseline and Week 12
Electrocardiography (ECG)
ECG will be evaluated at baseline and Week 12
Adverse events
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01645332
Brief Title
Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus
Official Title
Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-2-diabetes Mellitus, New Onset
Keywords
DLBS3233, new onset, type-2-diabetes mellitus, oral anti-hyperglycemic agent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment I (control)
Arm Type
Placebo Comparator
Arm Description
Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification
Arm Title
Treatment II
Arm Type
Experimental
Arm Description
100 mg DLBS3233 once daily for 12 weeks + lifestyle modification
Intervention Type
Drug
Intervention Name(s)
Placebo of DLBS3233
Other Intervention Name(s)
Placebo of Inlacin
Intervention Description
Placebo of DLBS3233 once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
DLBS3233
Other Intervention Name(s)
Inlacin
Intervention Description
100 mg DLBS3233 once daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Lifestyle modification
Intervention Description
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 Outcome Measure Information:
Title
Reduction of A1c level
Description
Reduction of A1c level from baseline to Week 12 of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction of venous FPG
Description
Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment
Time Frame
6 weeks and 12 weeks
Title
Reduction of venous 2h-PG
Description
Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment
Time Frame
6 weeks and 12 weeks
Title
Response rate
Description
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
Time Frame
12 weeks
Title
Change in fasting insulin level
Description
Change in fasting insulin level from baseline to Week 12 of treatment
Time Frame
12 weeks
Title
Change in HOMA-IR
Description
Change in HOMA-IR from baseline to Week 12 of treatment
Time Frame
12 weeks
Title
Change in HOMA-B
Description
Change in HOMA-B from baseline to Week 12 of treatment
Time Frame
12 weeks
Title
Change in adiponectin level
Description
Change in adiponectin level from baseline to Week 12 of treatment
Time Frame
12 weeks
Title
Change in lipid profile
Description
Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment
Time Frame
12 weeks
Title
Change in body weight
Description
Change in body weight from baseline to Week 6 and Week 12 of treatment
Time Frame
6 weeks and 12 weeks
Title
Vital signs
Description
Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12
Time Frame
6 weeks and 12 weeks
Title
Liver function
Description
Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12
Time Frame
12 weeks
Title
Renal function
Description
Renal function (serum creatinine level) will be evaluated at baseline and Week 12
Time Frame
12 weeks
Title
Electrocardiography (ECG)
Description
ECG will be evaluated at baseline and Week 12
Time Frame
12 weeks
Title
Adverse events
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heri Nugroho, Dr,dr,SpPD,KEMD,FINASIM
Organizational Affiliation
Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital
City
Semarang
State/Province
Jawa Tengah
ZIP/Postal Code
50231
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus
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