Clinical trial NCT01645332: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type-2-diabetes Mellitus
New Onset
Keywords: DLBS3233
new onset
type-2-diabetes mellitus
oral anti-hyperglycemic agent
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of A1c level
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction of venous FPG
timeFrame: 6 weeks and 12 weeks
measure: Reduction of venous 2h-PG
timeFrame: 6 weeks and 12 weeks
measure: Response rate
timeFrame: 12 weeks
measure: Change in fasting insulin level
timeFrame: 12 weeks
measure: Change in HOMA-IR
timeFrame: 12 weeks
measure: Change in HOMA-B
timeFrame: 12 weeks
measure: Change in adiponectin level
timeFrame: 12 weeks
measure: Change in lipid profile
timeFrame: 12 weeks
measure: Change in body weight
timeFrame: 6 weeks and 12 weeks
measure: Vital signs
timeFrame: 6 weeks and 12 weeks
measure: Liver function
timeFrame: 12 weeks
measure: Renal function
timeFrame: 12 weeks
measure: Electrocardiography (ECG)
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital
state: Jawa Tengah
Study officials:
affiliation: Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia
name: Heri Nugroho, Dr,dr,SpPD,KEMD,FINASIM
role: PRINCIPAL_INVESTIGATOR
References: