Phase 3 N=24 Randomized Quadruple-blind Treatment

Impact of Mulberry Leaf on Type 2 Diabetes

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00795704 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Aug 2012

Primary outcome: Primary: Hemoglobin A1C — -0.39; -0.26 percent — p=0.079

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mulberry Leaf Extract (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Mississippi Medical Center
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemoglobin A1C	-0.39; -0.26	0.079
SECONDARY Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels	6; 4	—
SECONDARY Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages	-28.1; 3.6	<0.05 sig

Summary

The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients.

Eligibility Criteria

Inclusion Criteria

Type 2 diabetes
No diabetes medication adjustments for at least 2 months
Stable hemoglobin A1C [Between 7.0% to 8.0% (inclusive) and not varying by more than 10% since prior visit; If no A1C exists prior to the current visit and no medication adjustments are made, the current A1C may used as the baseline]

Exclusion Criteria

On insulin
History of overt cardiovascular disease
History of missed appointments or non-compliance with medications
History of hepatic or renal insufficiency
History of hemoglobinopathies
Women of reproductive potential not on oral contraceptives
Pregnant/nursing women.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00795704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.