Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

Abbott

Status and phase

Completed

Phase 3

Phase 2

Conditions

Type 2 Diabetes

Treatments

Other: herbal extract; root of woody shrub grown in India/Sri-Lanka

Study type

Interventional

Funder types

Industry

Identifiers

BJ82

Details and patient eligibility

About

The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.

Enrollment

59 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

type 2 diabetes
Between 18 and 75 years of age
Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
If of childbearing potential, is practicing birth control
BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit

Exclusion criteria

Uses insulin for glucose control or has type 1 diabetes
History of diabetic ketoacidosis.
Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
Active malignancy
Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
End state organ failure or status post organ transplant
History of renal disease
Current hepatic disease
History of severe gastroparesis
Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
Clotting or bleeding disorders
Allergic or intolerant to any ingredient found in the study products