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Tang-min-ling pills low dosage

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |China Pharma Holdings, Inc.|Last Updated: Apr 21, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment210
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01107171Trial of Tang-min-ling Pills in the Treatment of Type 2 DiabetesPHASE2 COMPLETED 210May 1, 2008Dec 1, 2008Apr 21, 20106 China
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Study Endpoints
Primary Endpoints
Hemoglobin A1c (HbA1c)
12 weeks after treatment

The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison.

Secondary Endpoints
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC)
12 weeks after treatment
symptoms score and Chinese syndrome
12 weeks after treatment
The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
12 weeks after treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
placeboPLACEBO_COMPARATORTang-min Lin pills analogue
Tang-min-ling pills high dosageEXPERIMENTALTang-min-ling pills, high dosage, 12g, tid po
Tang-min-ling pills low dosageEXPERIMENTALlow dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
Interventions
NameTypeDescription
Tang-min-ling pills low dosageDRUGlow dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
Tang-min-ling pills high dosageDRUGhigh dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
PlaceboDRUGTang-min-Ling pills analogue 6g,tid,po
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Eligibility Criteria
Age Range30 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Patients with primary type 2 diabetes mellitus 2. BMI ≥ 24 kg•m-2 3. 30-70 years old 4. HbA1c≥7.0%, and FPG\>7.0 mmol/L, but \<13.9 mmol/L or 2hPG\>11.1 mmol/L 5. Informed consent has been signed 6. stagnated heat of liver and stomach syndrome according to TCM syndrome differ...

Countries:China
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